CLA Soft Chew Strawberry Banana Smoothie [Discontinued] by GNC Total Lean

POSSIBLY EFFECTIVE

• Hypertension. Oral CLA seems to modestly reduce blood pressure when used along with ramipril. However, oral CLA alone does not seem to reduce blood pressure. Details: A meta-analysis of small clinical trials shows that taking CLA in doses of 1 gram to 10.8 grams daily does not lower systolic or diastolic blood pressure when compared with placebo or a control diet (111053). However, this analysis is limited by the heterogeneous populations in the individual studies. Only one study was specifically conducted in individuals with hypertension (45569). This small clinical trial in individuals with stage one uncontrolled hypertension shows that taking CLA 4.5 grams daily along with ramipril 37.5 mg daily for 8 weeks modestly reduces systolic and diastolic blood pressure when compared with ramipril alone (45569).
• Obesity. In adults and children, oral CLA seems to decrease fat mass by a small amount, including abdominal fat mass. However, it is unclear if oral CLA is beneficial for weight loss, body mass index (BMI) reduction, or improvement of metabolic measures. Details: Taking CLA 3-6.8 grams daily seems to decrease body fat mass, increase lean body mass, and reduce waist and hip circumference in some patients (2819,3153,4947,13137,45295,45303,45685,45799,97003,105809). A meta-analysis of clinical research in adults with overweight or obesity also undergoing an exercise program shows a small effect on body fat reduction, but not body weight or plasma lipids (111056). Most research suggests that doses greater than 3.4 grams daily do not seem to offer any additional benefit when compared with lower doses (2819,2821,3153,4947,10410,11327,13137,45295,45799). Also, supplementing milk with CLA 3 grams daily seems to reduce total fat mass in individuals with overweight when compared with placebo (45331). CLA also seems to reduce hunger and improve satiety and feelings of fullness, but this appetite suppression does not necessarily result in a lower energy intake or improved body weight maintenance (11327). In children with overweight aged 6-10 years, taking CLA 3 grams daily for approximately 7 months seems to reduce body fat, abdominal fat, and peripheral fat percentages when compared with placebo (45713). There is inconsistent evidence regarding the effects of CLA on body weight and BMI, with most research suggesting that CLA does not reduce total body weight or BMI (2819,2821,3153,10410,13137,45007,45679,45790,97003,97006). Also, taking CLA in combination with omega-3 fatty acids or chromium picolinate does not seem to improve BMI and body weight in individuals with overweight or obesity (42627,45431). Although one meta-analysis of clinical research shows that taking CLA 2.4-6 grams daily for 6-12 months increases weight loss by 0.7 kg and fat loss by 1.3 kg when compared with placebo, this effect is small and may not be clinically significant (91585). Also, taking CLA 3.4 grams daily for 1 year does not seem to prevent weight or body fat regain in individuals with overweight who previously lost some of their initial body weight (45083,45221). However, one study shows that taking CLA 8 grams daily for 16 weeks seems to reduce BMI in obese, postmenopausal adults with type 2 diabetes (45614). Some studies have evaluated the consumption of CLA-enriched fatty foods. In males with overweight, consuming butter enriched with CLA does not seem to have beneficial metabolic effects (45192). Also, in individuals with overweight or obesity, consuming a goat cheese naturally enriched in CLA and omega-3 fatty acids for 12 weeks does not seem to improve BMI, fat mass, or weight, or most metabolic measures, including fasting glucose, blood pressure, or inflammatory factors, when compared to a control goat cheese. However, there was an increase in total cholesterol, possibly related to an increase in high-density lipoprotein (HDL) cholesterol, and reduced levels of C-reactive protein (CRP) (105808). There is evidence that the isolated trans-10,cis-12 isomer of CLA can increase hyperproinsulinemia and insulin resistance in patients with abdominal obesity (2821,13026,13137). Hyperproinsulinemia is an independent risk factor for type 2 diabetes and cardiovascular disease. Therefore, CLA might not be a good choice for obese patients. However, most commercial CLA products contain a mixture of CLA isomers. It is not known if these mixed CLA isomer products carry this risk. One meta-analysis of clinical research shows that insulin resistance is modestly reduced when a CLA supplement is taken by adults undergoing an exercise program when compared with exercise alone (111056).

POSSIBLY INEFFECTIVE

• Common cold. Oral CLA does not seem to be beneficial for common cold prevention or treatment. Details: Some clinical research shows that taking CLA 2 grams daily does not reduce the risk of developing a cold or reduce cough or sore throat severity in individuals with a common cold when compared with placebo (45577).
• Diabetes. Oral CLA does not seem to be beneficial for diabetes. Details: Some clinical research shows that taking CLA 6.4 grams daily for 16 weeks does not improve fasting glucose, postprandial glucose, or insulin in individuals with type 2 diabetes when compared with safflower oil (45614,45835).
• Hyperlipidemia. Oral CLA does not seem to be beneficial for hyperlipidemia. Details: A meta-analysis and individual clinical trials show that taking CLA as supplements or fortified foods does not improve levels of cholesterol or triglycerides (45790,97006,111054). One meta-analysis of small clinical trials in heterogenous populations shows that taking CLA does not improve levels of total cholesterol, low-density lipoprotein (LDL) cholesterol, or triglycerides, and modestly DECREASES levels of high-density lipoprotein (HDL) cholesterol, when compared with taking placebo or a control diet (111054). CLA has generally been taken in doses of 1.4 to 6.8 grams daily for up to 24 weeks (45790,97006,111054). However, research in patients with hyperlipidemia is limited. Most studies have included general populations of healthy adults, patient with type 2 diabetes, or populations with obesity.

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Allergic rhinitis (hay fever). It is unclear if oral CLA is beneficial for reducing symptoms of allergic rhinitis. Details: Clinical research shows that taking CLA 2 grams daily for 12 weeks improves overall well-being in patients with birch pollen allergy when compared with placebo, but does not improve eye or total allergy symptoms (45395).
• Asthma. It is unclear if oral CLA is beneficial for reducing symptoms of asthma. Details: A small clinical trial in patients with mild asthma shows that taking CLA 4.5 grams daily for 12 weeks improves airway hypersensitivity and tolerance to strenuous exercise when compared with placebo, but without significantly reducing the need to use rescue bronchodilators or improving lung capacity (45787). In addition, a small clinical trial in children 6-18 years of age with allergic asthma shows that taking CLA 3 grams daily for 12 weeks does not reduce the use of emergency bronchodilators or improve peak expiratory flow, forced expiratory volume (FEV1), or vital lung capacity when compared with placebo (97005).
• Atherosclerosis. Although there is interest in using oral CLA for preventing atherosclerosis, there is insufficient reliable information about the clinical effects of CLA for this purpose.
• Athletic performance. It is unclear if oral CLA is beneficial for improving athletic performance. Details: Some preliminary clinical research in student athletes shows that taking CLA powder (CLAce Powder, The Nisshin OilliO Group, Ltd.) 900 mg daily for 14 days increases time to exhaustion during exercise by an average of 179 seconds, but does not reduce rate of perceived exertion, when compared with placebo (97002). Other small clinical trials show that taking a specific product containing CLA oil (Clarinol A-80, Stepan Specialty Products, LLC) 5.63 grams daily for 6 weeks in combination with aerobic training does not improve muscle endurance, muscle power, peak oxygen uptake, or cardiorespiratory fatigue threshold when compared with placebo in untrained to moderately trained males (91587,91588).
• Breast cancer. It is unclear if dietary CLA is beneficial for preventing breast cancer. Details: Some observational research has found that a higher intake of CLA in foods, particularly cheese, is linked with a lower risk of developing breast cancer in postmenopausal individuals (5058). However, other population research has found that intake of CLA is not associated with a reduced risk of breast cancer (45609). Furthermore, some epidemiological evidence has found that CLA intake might be weakly associated with an increased risk of breast cancer (45048).
• Cognitive function. It is unclear if oral CLA is beneficial for improving cognitive function in older adults. Details: Preliminary clinical research in older adults shows that taking CLA 1.75 grams twice daily for 6 weeks may modestly improve verbal learning and recall in males, but not females, when compared with placebo (97008).
• Colorectal cancer. It is unclear if dietary CLA is beneficial for preventing colorectal cancer. Details: Epidemiological research has found that high dietary intake of CLA might reduce the risk of colorectal cancer in females by up to 39% (13775). It is not known if taking CLA supplements is associated with a reduced risk of colorectal cancer.
• Metabolic syndrome. It is unclear if oral CLA is beneficial for metabolic syndrome. Details: Evidence from a small clinical trial shows that taking CLA 3 grams daily orally for 90 days, along with a hypocaloric diet, decreases body fat mass by approximately 3% when compared to baseline in females with metabolic syndrome. However, this reduction does not appear to be significant when compared with placebo treatment, and CLA does not lower blood lipid levels or blood pressure (91586).
• Muscle strength. It is unclear if oral CLA is beneficial for increasing muscle strength. Details: Some preliminary clinical research shows that adding CLA 6 grams to supplementation with creatine 9 grams and whey protein 36 grams daily for 12 weeks modestly enhances strength improvement and lean tissue mass when compared with placebo in adults participating in strength training (45596). However, other clinical research shows that taking CLA 5 grams daily for 7 weeks does not improve most measures of strength in adults participating in resistance training when compared with placebo, although bench press strength was modestly improved in males, and lean tissue mass and fat mass were also improved (45222). Other clinical research shows that taking CLA 6 grams daily for 4 weeks does not improve body composition or strength in resistance-trained athletes (45041). The reasons for these discrepancies are unclear, but may be related to the duration of treatment.
• Nonalcoholic fatty liver disease (NAFLD). It is unclear if oral CLA is beneficial for NAFLD. Details: Preliminary clinical research shows that taking CLA (Nutrifit, Nutricentury) 1 gram three times daily in conjunction with a weight loss diet for 8 weeks reduces fat mass, low-density lipoprotein (LDL) cholesterol levels, and alanine aminotransferase (ALT) levels and increases muscle mass when compared with a weight loss diet alone in obese adults with NAFLD. CLA was also associated with a reduction in glycated hemoglobin, but with no corresponding reduction in fasting plasma glucose (97004).
• Physical performance. It is unclear if oral CLA is beneficial for improving physical performance in older adults. Details: Preliminary clinical research in adults 65-85 years of age shows that taking CLA 1.75 grams twice daily for 6 weeks does not improve handgrip strength or hand discomfort when compared with placebo (97008).
• Rheumatoid arthritis (RA). It is unclear if oral CLA is beneficial for RA. Details: Preliminary clinical research shows that taking CLA 2.5 grams daily with or without vitamin E 400 mg daily for 12 weeks reduces pain and morning stiffness and reduces erythrocyte sedimentation rate in patients with RA when compared to baseline (45730). The validity of these findings is limited by the lack of a comparator group. More evidence is needed to rate conjugated linoleic acid for these uses.

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LIKELY EFFECTIVE

• Cystic fibrosis. Long-term nebulized hypertonic sodium chloride improves lung function and reduces pulmonary exacerbations in patients with cystic fibrosis. Details: Meta-analyses of clinical research in adults with cystic fibrosis show that, when taken along with a bronchodilator and other standard therapies, nebulized hypertonic sodium chloride in concentrations of 3% to 7%, up to 10 mL twice daily for 4 weeks, increases forced expiratory volume at one second (FEV1) when compared with isotonic saline (sodium chloride 0.9%) (26230,26230). This benefit was not seen at 48 weeks. Other clinical research in adults with cystic fibrosis shows that inhaling sodium chloride 7%, 4 mL twice daily for 48 weeks, does not improve FEV1 when compared with isotonic saline. However, chronic treatment with hypertonic saline does reduce the number of pulmonary exacerbations and increase the number of patients without pulmonary exacerbations when compared with isotonic saline (29402). It is not clear if this benefit occurs in children with cystic fibrosis. The Pulmonary Clinical Practice Guidelines Committee of the Cystic Fibrosis Foundation recommends that individuals with cystic fibrosis aged 6 years or older use nebulized hypertonic saline long-term to improve lung function, reduce the number of exacerbations, and improve quality of life (29403).

POSSIBLY EFFECTIVE

• Amphotericin B nephrotoxicity. Oral sodium chloride seems to prevent nephrotoxicity associated with use of amphotericin B. Details: Clinical research shows that administering oral or intravenous sodium chloride 150 mEq daily during treatment with amphotericin B can attenuate the rise in serum creatinine levels and preserve renal function when compared to treatment with amphotericin B alone (26226).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Bipolar disorder. It is unclear if oral sodium is beneficial in preventing lithium level fluctuations in patients with bipolar disorder. Details: A moderate-sized open-label clinical study in adults with type I bipolar disorder receiving lithium carbonate shows that taking sodium chloride 1 gram daily for 12 weeks along with dietary salt restriction of 1 gram daily reduces the percentage of patients with lithium level fluctuations above 0.8 mEq/L, but does not significantly affect serum sodium, potassium, aldosterone, or creatinine levels when compared with controls who were not salt restricted, but were advised not to consume additional salt at the table (112909). However, the interpretation of these findings is limited by missing data in both groups.
• Canker sores. Although there is interest in using topical sodium chloride for canker sores, there is insufficient reliable information about the clinical effects of sodium chloride for this condition.
• Congestive heart failure. It is unclear if oral sodium is beneficial in patients with acute decompensated heart failure requiring decongestive therapy with diuretics. Details: A moderate-sized clinical study in adults hospitalized with acute decompensated heart failure requiring high-dose intravenous furosemide shows that taking sodium chloride 2 grams three times daily for up to 96 hours does not affect patient weight or serum creatinine levels when compared with placebo (112911). However, the clinical relevance of this study is unclear and it may have been inadequately powered to detect a difference between groups.
• Conjunctivitis. Although there is interest in using ophthalmic sodium chloride for conjunctivitis, there is insufficient reliable information about the clinical effects of sodium chloride for this condition.
• Hyponatremia. Although there is interest in using oral sodium chloride for hyponatremia, there is insufficient reliable information about the clinical effects of oral sodium chloride for this condition.
• Pharyngitis. Although there is interest in using topical sodium chloride for pharyngitis, there is insufficient reliable information about the clinical effects of sodium chloride for this condition.
• Prematurity. It is unclear if oral sodium is beneficial for premature infants. Details: Preliminary clinical research in infants born at less than 32 weeks' gestation shows that adding sodium 4 mEq/kg daily to enteral feedings, starting from the 7th day after birth and continuing through the 35th day, reduces the risk of developing hyponatremia and improves weight gain when compared with adding water (98180). A small, open-label clinical study in newborns less than 35 weeks gestation shows that high sodium intake, defined as an average of 0.25% sodium in maintenance fluids, for 48 hours on day 2 and 3 after birth results in less weight loss within the first 72 hours of life when compared with control, but does not improve mortality, length of hospital stay, or complications from prematurity (112908). However, interpretation of these findings is limited by varied concentrations of sodium as an intervention. More evidence is needed to rate sodium for these uses.

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LIKELY SAFE ...when used orally in amounts found in foods. CLA occurs naturally in milk fat, beef, and the meat of other ruminant animals (5924,5925,5932,5933).

POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts of up to 6. 8 grams daily, short-term (2819,2821,3153,4947,10410,11327,111056).

CHILDREN: LIKELY SAFE
when used orally in amounts found in foods. CLA occurs naturally in milk fat, beef, and the meat of other ruminant animals (5924,5925,5932,5933).

CHILDREN: POSSIBLY SAFE
when used orally and appropriately in medicinal amounts. Some evidence suggests that CLA 3 grams daily can be taken safely for up to 7 months (45713).

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in amounts found in foods (5924,5932,5933). There is insufficient reliable information available about the safety of CLA when used in medicinal amounts during pregnancy or lactation; avoid using.

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LIKELY SAFE ...when used orally and appropriately. Sodium is safe in amounts that do not exceed the Chronic Disease Risk Reduction (CDRR) intake level of 2.3 grams daily (100310). Higher doses can be safely used therapeutically with appropriate medical monitoring (26226,26227).

POSSIBLY UNSAFE ...when used orally in high doses. Tell patients to avoid exceeding the CDRR intake level of 2.3 grams daily (100310). Higher intake can cause hypertension and increase the risk of cardiovascular disease (26229,98176,98177,98178,98181,98183,98184,100310,109395,109396,109398,109399). There is insufficient reliable information available about the safety of sodium when used topically.

CHILDREN: LIKELY SAFE
when used orally and appropriately (26229,100310). Sodium is safe in amounts that do not exceed the CDRR intake level of 1.2 grams daily for children 1 to 3 years, 1.5 grams daily for children 4 to 8 years, 1.8 grams daily for children 9 to 13 years, and 2.3 grams daily for adolescents (100310).

CHILDREN: POSSIBLY UNSAFE
when used orally in high doses. Tell patients to avoid prolonged use of doses exceeding the CDRR intake level of 1.2 grams daily for children 1 to 3 years, 1.5 grams daily for children 4 to 8 years, 1.8 grams daily for children 9 to 13 years, and 2.3 grams daily for adolescents (100310). Higher intake can cause hypertension (26229).

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally and appropriately. Sodium is safe in amounts that do not exceed the CDRR intake level of 2.3 grams daily (100310).

PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when used orally in higher doses. Higher intake can cause hypertension (100310). Also, both the highest and the lowest pre-pregnancy sodium quintile intakes are associated with an increased risk of hypertensive disorders of pregnancy, including gestational hypertension and pre-eclampsia, and the delivery of small for gestational age (SGA) infants when compared to the middle intake quintile (106264).

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ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, CLA may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs.  Details Some clinical evidence suggests that intake of CLA reduces platelet aggregation by approximately 10% (45607). The clinical significance of this effect is unclear.

ANTIHYPERTENSIVE DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = A Theoretically, taking CLA with antihypertensive drugs might increase the risk of hypotension.  Details Animal research suggests that a particular form of CLA reduces systolic blood pressure (45081). Also, some clinical research shows that CLA enhances the blood pressure-lowering effects of ramipril, an antihypertensive drug (45569).

RAMIPRIL (ALTACE) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = A Theoretically, taking black seed with ramipril might increase the risk of hypotension.  Details Some clinical research shows that CLA enhances the blood pressure-lowering effects of ramipril (45569).

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ANTIHYPERTENSIVE DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = A Theoretically, a high intake of dietary sodium might reduce the effectiveness of antihypertensive drugs.  Details High intake of dietary sodium can increase systolic and diastolic blood pressure (26222). Also, high intake of sodium may necessitate increased use of antihypertensive medications to achieve blood pressure control in some patients, such as those with chronic kidney disease (26223).

CORTICOSTEROIDS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Concomitant use of mineralocorticoids and some glucocorticoids with sodium supplements might increase the risk of hypernatremia.  Details Mineralocorticoids and some glucocorticoids (corticosteroids) cause sodium retention. This effect is dose-related and depends on mineralocorticoid potency. It is most common with hydrocortisone, cortisone, and fludrocortisone, followed by prednisone and prednisolone (4425).

LITHIUM Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = B Altering dietary intake of sodium might alter the levels and clinical effects of lithium.  Details High sodium intake can reduce plasma concentrations of lithium by increasing lithium excretion (26225). Reducing sodium intake can significantly increase plasma concentrations of lithium and cause lithium toxicity in patients being treated with lithium carbonate (26224,26225). Stabilizing sodium intake is shown to reduce the percentage of patients with lithium level fluctuations above 0.8 mEq/L (112909). Patients taking lithium should avoid significant alterations in their dietary intake of sodium.

SODIUM-CONTAINING DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Concomitant use of sodium-containing drugs with additional sodium from dietary or supplemental sources may increase the risk of hypernatremia and long-term sodium-related complications.  Details The Chronic Disease Risk Reduction (CDRR) intake level of 2.3 grams of sodium daily indicates the intake at which it is believed that chronic disease risk increases for the apparently healthy population (100310). Some medications contain high quantities of sodium. When used in conjunction with sodium supplements or high-sodium diets, the CDRR may be exceeded. Additionally, concomitant use may increase the risk for hypernatremia; this risk is highest in the elderly and people with other risk factors for electrolyte disturbances.

TOLVAPTAN (Samsca) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = C Theoretically, concomitant use of tolvaptan with sodium might increase the risk of hypernatremia.  Details Tolvaptan is a vasopressin receptor 2 antagonist that is used to increase sodium levels in patients with hyponatremia (29406). Patients taking tolvaptan should use caution with the use of sodium salts such as sodium chloride.

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General ...Orally, CLA is well tolerated when found in foods. When taken in medicinal amounts, CLA seems to be well tolerated.
Most Common Adverse Effects:
Orally: Diarrhea, dyspepsia, flatulence, loose stools, and nausea.
Serious Adverse Effects (Rare) :
Orally: Cases of hepatotoxicity have been reported.

Cardiovascular ...Some preliminary clinical research suggests that the t10,c12 isomer of CLA can decrease high-density lipoprotein (HDL) cholesterol levels (2821). This isomer of CLA, as well as a mixture of CLA isomers, seems to increase plasma triglyceride levels, the ratio of low-density lipoprotein (LDL) cholesterol to HDL cholesterol, and the ratio of total cholesterol to HDL cholesterol (45148,45468), although not all research has identified these effects (107475).
A meta-analysis of 6 randomized, controlled trials shows that administration of CLA in individuals who are overweight or obese significantly increases lipoprotein (a) levels, a value associated with increased risk of cardiovascular disease. Subgroup analyses suggest this increase is more prominent in trials that are longer than 6 months in duration and with CLA doses of at least 3.5 grams daily (107475).

Endocrine ...Orally, CLA has been shown to increase insulin resistance and glucose concentrations, as well as decrease insulin sensitivity in some patients, including obese individuals or patients with type 2 diabetes (2821,13026,45145,45152,45513). Some evidence suggests that this effect is isomer-specific and occurs with only the t10,c12 isomer (2821,13026), while other evidence shows that decreased insulin sensitivity may also occur with the c9,t11 isomer or with a 50:50 mixture of c9,t11 and t10,c12 isomers (45145,45152).

Gastrointestinal ...Orally, the most common adverse effect reported with CLA is gastrointestinal upset including diarrhea, constipation, nausea, loose stools, dyspepsia, bloating, and flatulence (3153,4947,45280,45705,45730,111056). Esophageal irritation was reported in one patient who bit open and swallowed a capsule containing CLA (45577).

Hepatic ...Orally, clinical research shows that CLA 3 grams daily for 12 weeks does not affect liver outcome measures (105809). However, there are at least two case reports of hepatotoxicity. Asthenia, jaundice, and pruritus were reported in a 46-year-old female who consumed CLA for two weeks. Abnormal liver enzyme levels returned to normal following discontinuation of CLA supplementation (45483). Hepatotoxicity, presenting as fulminant hepatitis and characterized by anorexia, nausea, jaundice, choluria, and hepatic encephalopathy requiring liver transplantation has also been reported in a 63-year-old female taking a CLA-containing weight-loss supplement for one month (91589).

Musculoskeletal ...Orally, CLA has been reported to cause back ache in one individual in one clinical trial (45787).

Neurologic/CNS ...Orally, CLA may cause headache or fatigue (3153,45787). In one case report, a 50-year-old female presented with headache and subarachnoid hemorrhage due to reversible cerebral vasoconstriction syndrome (RCVS) after taking a combination product containing green tea, L-carnitine, and CLA for one week. At 28 days after discontinuation of the combination product and surgery, angiography showed complete regression of vascular restrictions (97007). It is unclear if this adverse effect was due to CLA, another ingredient in the product, or a combination of ingredients.

Other ...Orally, CLA has been reported to cause halitosis in one patient in one clinical trial (45839).

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General ...Orally, sodium is well tolerated when used in moderation at intakes up to the Chronic Disease Risk Reduction (CDRR) intake level. Topically, a thorough evaluation of safety outcomes has not been conducted.
Serious Adverse Effects (Rare):
Orally: Worsened cardiovascular disease, hypertension, kidney disease.

Cardiovascular ...Orally, intake of sodium above the CDRR intake level can exacerbate hypertension and hypertension-related cardiovascular disease (CVD) (26229,98176,100310,106263). A meta-analysis of observational research has found a linear association between increased sodium intake and increased hypertension risk (109398). Observational research has also found an association between increased sodium salt intake and increased risk of CVD, mortality, and cardiovascular mortality (98177,98178,98181,98183,98184,109395,109396,109399). However, the existing research is unable to confirm a causal relationship between sodium intake and increased cardiovascular morbidity and mortality; high-quality, prospective research is needed to clarify this relationship (100312). As there is no known benefit with increased salt intake that would outweigh the potential increased risk of CVD, advise patients to limit salt intake to no more than the CDRR intake level (100310).
A reduction in sodium intake can lower systolic blood pressure by a small amount in most individuals, and diastolic blood pressure in patients with hypertension (100310,100311,106261). However, post hoc analysis of a small crossover clinical study in White patients suggests that 24-hour blood pressure variability is not affected by high-salt intake compared with low-salt intake (112910). Additionally, the available research is insufficient to confirm that a further reduction in sodium intake below the CDRR intake level will lower the risk for chronic disease (100310,100311). A meta-analysis of clinical research shows that reducing sodium intake increases levels of total cholesterol and triglycerides, but not low-density lipoprotein (LDL) cholesterol, by a small amount (106261).
It is unclear whether there are safety concerns when sodium is consumed in amounts lower than the adequate intake (AI) levels. Some observational research has found that the lowest levels of sodium intake might be associated with increased risk of death and cardiovascular events (98181,98183). However, this finding has been criticized because some of the studies used inaccurate measures of sodium intake, such as the Kawasaki formula (98177,98178,101259). Some observational research has found that sodium intake based on a single 24-hour urinary measurement is inversely correlated with all-cause mortality (106260). The National Academies Consensus Study Report states that there is insufficient evidence from observational studies to conclude that there are harmful effects from low sodium intake (100310).

Endocrine ...Orally, a meta-analysis of observational research has found that higher sodium intake is associated with an average increase in body mass index (BMI) of 1. 24 kg/m2 and an approximate 5 cm increase in waist circumference (98182). It has been hypothesized that the increase in BMI is related to an increased thirst, resulting in an increased intake of sugary beverages and/or consumption of foods that are high in salt and also high in fat and energy (98182). One large observational study has found that the highest sodium intake is not associated with overweight or obesity when compared to the lowest intake in adolescents aged 12-19 years when intake of energy and sugar-sweetened beverages are considered (106265). However, in children aged 6-11 years, usual sodium intake is positively associated with increased weight and central obesity independently of the intake of energy and/or sugar-sweetened beverages (106265).

Gastrointestinal ...In one case report, severe gastritis and a deep antral ulcer occurred in a patient who consumed 16 grams of sodium chloride in one sitting (25759). Chronic use of high to moderately high amounts of sodium chloride has been associated with an increased risk of gastric cancer (29405).

Musculoskeletal ...Observational research has found that low sodium levels can increase the risk for osteoporosis. One study has found that low plasma sodium levels are associated with an increased risk for osteoporosis. Low levels, which are typically caused by certain disease states or chronic medications, are associated with a more than 2-fold increased odds for osteoporosis and bone fractures (101260).
Conversely, in healthy males on forced bed rest, a high intake of sodium chloride (7.7 mEq/kg daily) seems to exacerbate disuse-induced bone and muscle loss (25760,25761).

Oncologic ...Population research has found that high or moderately high intake of sodium chloride is associated with an increased risk of gastric cancer when compared with low sodium chloride intake (29405). Other population research in patients with gastric cancer has found that a high intake of sodium is associated with an approximate 65% increased risk of gastric cancer mortality when compared with a low intake. When zinc intake is taken into consideration, the increased risk of mortality only occurred in those with low zinc intake, but the risk was increased to approximately 2-fold in this sub-population (109400).

Pulmonary/Respiratory ...In patients with hypertension, population research has found that sodium excretion is modestly and positively associated with having moderate or severe obstructive sleep apnea. This association was not found in normotensive patients (106262).

Renal ...Increased sodium intake has been associated with impaired kidney function in healthy adults. This effect seems to be independent of blood pressure. Observational research has found that a high salt intake over approximately 5 years is associated with a 29% increased risk of developing impaired kidney function when compared with a lower salt intake. In this study, high salt intake was about 2-fold higher than low salt intake (101261).

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