Slimvance Core Slimming Complex Raspberry Iced Tea by GNC BodyDynamix

POSSIBLY INEFFECTIVE

• Obesity. Most research shows that taking oral caralluma extract does not result in clinically meaningful improvements in weight loss in patients with obesity. Details: Small clinical studies in adults with obesity have shown conflicting effects of caralluma on weight loss and appetite (15272,94080,99999,106437). A meta-analysis of these studies shows that taking caralluma extract 500 mg orally twice daily for 8-16 weeks reduces waist circumference by 1.6 cm, but does not affect body weight, body mass index, or appetite, when compared with placebo (109492). Taking caralluma also does not affect serum lipids or blood pressure (15272,94080,99999,106437,109492).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Generalized anxiety disorder (GAD). It is unclear if oral caralluma is beneficial for GAD. Details: Preliminary clinical research in patients with mild to moderate GAD shows that taking caralluma 500 mg twice daily with food for 8 weeks improves measures of anxiety and stress when compared with placebo. Reductions in anxiety were approximately 1.7-fold greater in patients taking caralluma (100000). However, the validity of these findings is limited by the low level of anxiety at baseline and the use of online reporting for symptom evaluation.
• Prader-Willi syndrome (PWS). It is unclear if oral caralluma is beneficial in children with PWS. Details: Preliminary clinical research in children and adolescents with PWS between the ages of 5 and 17 shows that taking a caralluma extract (Slimaluma, Gencor Pacific International Ltd.) 25 mg/kg, up to 1000 mg daily for 4 weeks, decreases hyperphagic drive and associated behaviors when compared with placebo. These results suggest the effects may be more pronounced in females and may be dose-dependent, with more improvement seen at the highest dose of 1000 mg daily (94081). More evidence is needed to rate caralluma for these uses.

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INSUFFICIENT RELIABLE EVIDENCE to RATE

• Constipation. It is unclear if oral polydextrose is beneficial in adults or children with constipation. Details: One small, low-quality, study in Japanese patients with dialysis-related constipation despite the use of laxatives shows that taking polydextrose 10 grams daily for 4 weeks increases weekly stool frequency from 3 stools to 8.5 stools, compared with an increase from 3.5 stools to 5 stools in the placebo group. However, taking polydextrose did not improve stool consistency, abdominal distention, or diarrhea when compared with placebo (98658). Other clinical research in adults with functional constipation shows that taking 4-12 grams of polydextrose orally daily for 2 weeks improves weekly stool frequency when compared with placebo. Preliminary subgroup analyses suggest that taking 12 grams of polydextrose may be more effective than lower doses. However, taking polydextrose did not improve colonic transit times or symptom scores when compared with placebo (106481). In contrast, clinical research in adults with chronic constipation shows that taking polydextrose (LitesseUltra, Danisco) 8 or 12 grams orally daily for 4 weeks does not improve stool consistency or frequency when compared with placebo (98659). Reasons for the conflicting results may relate to heterogeneity among the trial participants, including baseline constipation severity, and the studied dose and duration of polydextrose. In children aged 4-8 years with functional constipation, preliminary clinical research shows that taking a mixture of polydextrose 4.17 grams and fructo-oligosaccharides 0.45 grams orally daily for 45 days improves the weekly frequency of bowel movements, clinical manifestations of constipation, and quality of stool type when compared with baseline (106482). It is unclear if these effects are due to polydextrose, fructo-oligosaccharides, or the combination. Also, the validity of these findings is limited by the lack of a comparator group.
• Diabetes. It is unclear if oral polydextrose is beneficial in patients with diabetes. Details: Preliminary clinical research shows that drinking 200 mL of a beverage containing polydextrose (Litesse, Danisco Sweeteners) 40 grams/L twice daily for 12 weeks does not affect fasting plasma glucose or glycated hemoglobin (HbA1c) when compared with placebo in individuals with impaired glucose tolerance, impaired fasting glucose, or diet-treated type 2 diabetes (34118).
• Impaired glucose tolerance (Prediabetes). It is unclear if oral polydextrose is beneficial in patients with prediabetes. Details: Preliminary clinical research shows that drinking 200 mL of a beverage containing polydextrose (Litesse, Danisco Sweeteners) 40 grams/L twice daily for 12 weeks does not affect fasting plasma glucose or glycated hemoglobin (HbA1c) when compared with placebo in individuals with impaired glucose tolerance, impaired fasting glucose, or diet-treated type 2 diabetes (34118).
• Irritable bowel syndrome (IBS). Oral polydextrose has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in adults with constipation-predominant IBS shows that consuming polydextrose 5.85 grams in a 350-mL sterilized probiotic beverage containing Lactobacillus helveticus once daily for 1 week does not improve constipation-related symptoms or intestinal transit time when compared with consuming the sterilized probiotic beverage alone (106480). Additionally, it is unclear how these findings would compare with the use of standard care. More evidence is needed to rate polydextrose for these uses.

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INSUFFICIENT RELIABLE EVIDENCE to RATE

• Diabetes. Preliminary clinical research in adults with type 2 diabetes shows that consuming salacia tea with each meal might lower glycated hemoglobin (HbA1C) levels (13508). Also, taking a single dose of salacia, in combination with a meal, decreases postprandial serum insulin and glucose levels in healthy volunteers and in patients with type 2 diabetes (13032,13507,15572). Other preliminary clinical research shows that taking salacia extract 240 mg daily as part of the diet for 6 weeks decreases fasting blood glucose and HbA1C levels when compared with baseline in patients with type 2 diabetes (72886). The validity of these findings is limited by the lack of a comparator group. There is insufficient reliable information available about the effectiveness of salacia for its other 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 commonly found in foods. A hydroethanolic extract of Caralluma has Generally Recognized as Safe (GRAS) status in the US (94084).

POSSIBLY SAFE ...when used orally in medicinal amounts, short-term. Caralluma extract 500 mg twice daily has been used with apparent safety for up to 12 weeks (15272,94080,99999). The maximum recommended adult dose is 1000 mg daily (94081).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

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LIKELY SAFE ...when used orally as a food additive. Polydextrose is considered by the US Food and Drug Administration (FDA) to be safe when used as a food additive, provided a single serving contains less than 15 grams (26210).

POSSIBLY SAFE ...when used orally and appropriately in divided doses up to 50 grams daily for 12 weeks (27193,34118,98658,98659,106478). However, polydextrose can have laxative effects when taken orally in doses greater than 90 grams daily or greater than 50 grams as a single dose (27193,106478).

POSSIBLY UNSAFE ...when used orally in higher doses. The European Food Safety Authority (EFSA) has determined that there is no need for an acceptable daily intake of polydextrose when used as a food additive (106478). However, polydextrose can have laxative effects when taken orally in doses greater than 90 grams daily or greater than 50 grams as a single dose (27193,106478).

CHILDREN: POSSIBLY SAFE
when used orally and appropriately. Polydextrose appears to be safe for infants when administered at doses of 2-4 grams per liter of formula and for children aged 4-8 years when administered at doses of about 4 grams daily. While some studies show no adverse effects of polydextrose, others suggest a potential for increased abdominal pain, diarrhea, and eczema (26709,27200,106482).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

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POSSIBLY SAFE ...when used orally, short-term. Salacia has been used with apparent safety as a single dose of 1000 mg (13032,13507). Salacia has also been used with apparent safety at a dose of 240 mg daily for up to 6 weeks (72886).

PREGNANCY AND LACTATION:
Insufficient reliable information available; 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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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, caralluma seems to be generally well tolerated.
Most Common Adverse Effects:
Orally: Abdominal distention, constipation, flatulence, and gastritis in the first 2 weeks of use.

Cardiovascular ...Orally, in one clinical trial, one patient with a history of hypertension receiving caralluma extract 500 mg twice daily experienced a transient increase in blood pressure. However, it subsided, and the subject remained on the extract without reappearance of the adverse event (94080).

Dermatologic ...Orally, caralluma extract use has been associated with the development of a mild skin rash in one person (99999).

Gastrointestinal ...Orally, in clinical trials, side effects have included gastrointestinal upset, abdominal distention, flatulence, constipation, and gastritis. These side effects appeared to subside within the first two weeks of use and have also been reported in patients taking placebo (15272,99999).

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General ...Orally, polydextrose seems to be well tolerated when used in doses of less than 50 grams.
Most Common Adverse Effects:
Orally: Bloating, diarrhea, gas.

Gastrointestinal ...Orally, polydextrose may cause gas, bloating, and loose stools (27194,27208,27212). These adverse effects are more common when single doses of more than 50 grams or daily doses of more than 90 grams are used. Higher doses of polydextrose (90 grams/day or more) may also cause transient diarrhea in some people (27193).

Neurologic/CNS ...Orally, one participant in one clinical study complained of transient dizziness after eating yogurt containing polydextrose 12. 5 grams (98660).

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General ...Orally, salacia seems to be well tolerated. It can cause flatulence, distention, belching, abdominal pain, nausea, and diarrhea. These side effects seem to be dose-dependent (13032,13507,15572). Drinking salacia tea can cause dyspepsia and loose stools (13508).

Gastrointestinal ...Orally, salacia can cause flatulence, distention, belching, abdominal pain, nausea, and diarrhea. These side effects seem to be dose-dependent (13032,13507,15572). Drinking salacia tea can cause dyspepsia and loose stools (13508). These gastrointestinal side effects are due to the fermentation of undigested carbohydrates in the bowel (15572).

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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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