Weight management products -
Despite treatments and lifestyle changes, some patients may not be able to lose weight or maintain weight-loss. For some weight-loss devices, patients should be evaluated and treated for eating disorders before considering device use as part of their obesity treatment.
An undiagnosed and untreated eating disorder can have serious health consequences for patients. Some devices are not for contraindicated in patients that have a history of eating disorders.
Medical professionals may also find it appropriate to closely monitor patients with certain weight-loss devices during treatment for evidence of an eating disorder. If you experience an injury or problem when using a weight-loss or weight-management device, we encourage you to file a voluntary report by phone at FDA or online at MedWatch, the FDA Safety Information and Adverse Event Reporting program.
In February , August , June , and April , the FDA issued letters to health care providers based on reports of patient problems related to liquid-filled gastric balloon systems, including death.
Other problems included a hole in the stomach gastric perforation ; sudden inflammation of the pancreas, which typically causes a sudden and severe stomach ache acute pancreatitis ; and balloons filling with air and enlarging, causing discomfort spontaneous hyperinflation.
The FDA continues to monitor these problems and recommends health care providers closely monitor patients who have liquid-filled gastric balloons for complications. Some research indicates that CLA has no major effect on lipid profiles, but other research shows that certain CLA isomers might decrease HDL cholesterol and increase lipoprotein a levels [ , , , ].
The CLA isomer t10,cCLA has also been reported to increase insulin resistance and glycemia in men with obesity and metabolic syndrome [ , ]. Fucoxanthin is a carotenoid in brown seaweed and other algae.
Results from laboratory and animal studies suggest that fucoxanthin might promote weight loss by increasing resting energy expenditure and fatty acid oxidation as well as by suppressing adipocyte differentiation and lipid accumulation [ , ]. Only one clinical trial has been conducted on the possible weight-loss effects of fucoxanthin.
This week trial used Xanthigen, a dietary supplement containing brown seaweed extract and pomegranate-seed oil [ ].
Compared to the placebo group, those receiving Xanthigen lost significantly more body weight by the end of the trial mean loss of 6. The safety of fucoxanthin has not been thoroughly evaluated in humans. Although participants using Xanthigen in the clinical trial described above reported no adverse effects [ ], further investigation of the safety and potential side effects of fucoxanthin at various levels of intake is required.
Garcinia cambogia is a fruit-bearing tree that grows throughout Asia, Africa, and the Polynesian islands [ ]. The pulp and rind of its fruit contain high amounts of hydroxycitric acid HCA , a compound that has been proposed to inhibit lipogenesis, increase hepatic glycogen synthesis, suppress food intake, and reduce weight gain [ 6 , 15 , , , ].
Studies in rats have found that Garcinia cambogia suppresses food intake and inhibits weight gain [ 3 ]. In humans, however, the evidence on whether Garcinia cambogia or HCA is effective for weight loss is conflicting, and any effects it has appear to be small [ 6 , 17 , ].
In one randomized, placebo-controlled trial, 89 women who were mildly overweight mean BMI Women receiving Garcinia cambogia lost significantly more weight 3.
However, Garcinia cambogia did not alter appetite, and the study produced no evidence that the supplement affected feelings of satiety.
Participants in both groups lost weight, but the between-group weight-loss differences were not statistically significant. HCA also had no effect on body fat loss. A review and meta-analysis of 12 randomized controlled trials with a total of participants examined the effects of Garcinia cambogia on weight loss [ ].
Therefore, the effect of Garcinia cambogia on body weight remains uncertain. The reported adverse effects of Garcinia cambogia and HCA are generally mild and include headache, nausea, upper respiratory tract symptoms, and gastrointestinal symptoms [ , , ].
However, dietary supplements containing Garcinia cambogia have been implicated in three cases of mania, which might have been caused by the serotonergic activity of HCA [ ].
Symptoms included grandiosity an unrealistic sense of superiority , irritability, pressured speech, and decreased need for sleep. Reports have also described 10 cases of liver toxicity, resulting in one death and two liver transplants, in people taking products containing Garcinia cambogia [ 43 , ].
In most of these cases, the products contained other botanical ingredients and minerals as well, so the toxicity cannot be definitively attributed to Garcinia cambogia. Because all clinical trials of Garcinia cambogia and HCA have been short, its long-term safety is unknown.
Glucomannan is a soluble dietary fiber derived from konjac root Amorphophallus konjac that can absorb up to 50 times its weight in water [ 16 ]. Like guar gum, glucomannan has been proposed to increase feelings of satiety and fullness and prolong gastric emptying by absorbing water in the gastrointestinal tract [ 16 , , ].
It might also reduce fat and protein absorption in the gut [ 16 ]. Glucomannan appears to have beneficial effects on blood lipids and glucose levels [ ], but its effects on weight loss are inconsistent. At the end of the study, glucomannan produced significantly greater weight loss mean loss of 2.
In another study conducted in the United States, supplementation with glucomannan 3. Eight weeks of glucomannan supplementation 1.
The authors of a systematic review of six randomized controlled trials with a total of participants concluded that 1.
Similarly, a meta-analysis of eight trials that included participants found that glucomannan did not significantly affect weight loss compared to placebo [ ]. The authors of an older meta-analysis of 14 studies designed primarily to investigate glucomannan's effect on lipid and blood glucose levels concluded that 1.
Little is known about the long-term safety of glucomannan. Glucomannan appears to be well tolerated for short-term use, with minor adverse effects, including belching, bloating, loose stools, flatulence, diarrhea, constipation, and abdominal discomfort [ , , , ].
The use of tablet forms of glucomannan was reported to be associated with seven cases of esophageal obstruction in — in Australia [ 99 ]. Users should therefore be cautious when taking glucomannan tablets.
Powdered and capsule forms have not been associated with this effect [ ]. The seeds or beans of the coffee plant Coffea arabica, Coffea canephora, Coffea robusta are green until they are roasted. Compared to roasted beans, green coffee beans have higher levels of chlorogenic acid.
Green coffee extract, probably because of its chlorogenic acid content, inhibits fat accumulation in mice and humans by regulating adipogenesis. Green coffee extract also modulates glucose metabolism [ ], perhaps by reducing glucose absorption in the gut [ ].
Green coffee beans contain caffeine see section on caffeine above [ ], although decaffeinated forms are available [ 16 ]. In mice, green coffee bean extract in combination with a high-fat diet significantly reduced body weight gain and fat mass [ , ].
Only a few clinical trials have examined the effects of green coffee bean extract on weight loss in humans, and all were of poor methodological quality. The researchers concluded that green coffee bean extract has a moderate but significant effect on body weight mean weight loss of 2.
The authors of another small clinical trial claimed to show a benefit of green coffee bean extract for weight loss [ ], but the study was strongly criticized by the FTC for having several critical flaws in its design [ , ].
Two of the three study authors subsequently retracted the journal publication. Green coffee bean extract appears to be well tolerated, but its safety has not been rigorously studied. Reported adverse effects include headaches and urinary tract infections [ ].
The caffeine naturally present in green coffee beans acts as a stimulant and can cause adverse effects, depending on the dose and whether it is combined with other stimulants see section on caffeine above.
Green tea Camellia sinensis is a popular beverage consumed worldwide that has several purported health benefits [ ]. Green tea is present in some dietary supplements, frequently in the form of green tea extract. The active components of green tea that are associated with weight loss are caffeine see section on caffeine above and catechins, primarily epigallocatechin gallate EGCG , which is a flavonoid [ 41 , ].
A typical brewed cup of green tea has about — mg catechins [ ] and 45 mg caffeine. It has been suggested that green tea and its components might reduce body weight by increasing energy expenditure and fat oxidation, reducing lipogenesis, and decreasing fat absorption [ 41 , ].
Green tea might also decrease carbohydrate digestion and absorption [ ]. Available green tea extracts cover the range from minimally processed tea leaves to highly processed, manufactured concentrates of single constituents, such as EGCG.
The authors of a meta-analysis of six randomized controlled trials with a total of 98 participants found that caffeine alone or in combination with catechins significantly increases energy expenditure in a dose-dependent fashion compared with placebo [ ]. This effect might be important for maintaining weight loss by helping counteract the decrease in metabolic rate that can occur during weight loss.
Catechins combined with caffeine also significantly increase fat oxidation, but caffeine alone does not. Other human research indicates that EGCG alone does not increase resting metabolic rate, fat oxidation, or the thermic effect of feeding the increase in metabolic rate associated with the digestion and absorption of food [ , ].
Taken together, these findings suggest that green tea catechins and caffeine might act synergistically [ 41 , , ]. Several human studies have examined the effects of green tea catechins on weight loss and weight maintenance. A Cochrane Review analyzed the results from 14 randomized controlled trials of green tea preparations in a total of 1, participants with overweight or obesity [ ].
The trials lasted from 12 to 13 weeks, and doses of green tea catechins ranged from to 1, mg; in 10 of the 14 trials, the green tea preparations contained caffeine. Green tea supplementation reduced body weight by a mean of 0. However, when the authors analyzed the six studies that were conducted outside of Japan where study methodologies were less heterogeneous than in the Japanese studies , they found no statistically significant difference in weight loss for green tea compared to placebo.
The authors reported that green tea catechins combined with caffeine over a median of 12 weeks modestly yet significantly reduced body weight by a mean of 1. Only two studies in this meta-analysis examined the effects of green tea catechins alone.
Their results suggest that green tea catechins alone do not affect body weight or other anthropometric measurements. A meta-analysis of 11 randomized controlled trials found that people who took EGCG combined with caffeine for 12—13 weeks lost a mean of 1.
In , EFSA examined health claims related to green tea and concluded that "a cause and effect relationship has not been established between the consumption of catechins including EGCG from green tea … and contribution to the maintenance or achievement of a normal body weight" [ ].
Taken together, the findings of these studies suggest that if green tea is an effective weight-loss aid, any effect it has is small and not likely to be clinically relevant [ , ].
No adverse effects have been reported from the consumption of green tea as a beverage [ ]. For green tea extract, most reported adverse effects are mild to moderate, and they include nausea, constipation, abdominal discomfort, and increased blood pressure [ ].
Toxicology studies in rats and mice show that green tea extract does not cause cancer but does cause nonneoplastic lesions in many areas of the body, including the nose, liver, and bone marrow [ ]. Other evidence in mice shows that high doses of catechins cause liver toxicity. There is also increasing evidence in humans that green tea extract might cause liver damage, though the underlying mechanism is not well understood [ ].
An analysis of 1, postmenopausal women participating in the Minnesota Green Tea Trial found that women who consumed green tea extract containing 1, mg total catechins including mg EGCG and Consumption of some green tea extracts—primarily ethanolic extracts of green tea—has also been linked to liver damage in at least 50 case reports since [ 43 , ].
In , the U. Pharmacopeia USP systematically reviewed the safety of green tea products [ ]. The USP noted that problems are more likely when green tea extract is taken on an empty stomach and, therefore, advises taking green tea extracts with food to minimize the possible risk of liver damage.
Other researchers and medical experts advise using dietary supplements containing green tea extract only with caution [ ]. Guar gum is a soluble dietary fiber derived from seeds of the Indian cluster bean Cyamopsis tetragonolobus [ 16 , ].
Guar gum is present in certain dietary supplements and is an ingredient in some food products, especially gluten-free baked goods, because it helps bind and thicken these products. Like glucomannan, guar gum is purported to promote weight loss by acting as a bulking agent in the gut; delaying gastric emptying; increasing feelings of satiety; and, theoretically, decreasing appetite and food intake [ 16 , ].
However, guar gum does not appear to enhance weight loss. In a meta-analysis of 20 randomized, double-blind, placebo-controlled trials that statistically pooled data from 11 trials, Pittler and colleagues evaluated the effects of guar gum for body weight reduction in a total of adults [ ].
Trial participants included people with hypercholesterolemia, hyperlipidemia, or type 1 or type 2 diabetes; menopausal women; and healthy volunteers. Compared with placebo, guar gum had no significant effect on weight loss. The authors concluded that guar gum is not effective for body weight reduction.
Reported adverse effects for guar gum are primarily gastrointestinal and include abdominal pain, flatulence, diarrhea, increased number of bowel movements, nausea, and cramps [ , , ]. Case reports indicate that guar gum can cause severe esophageal and small-bowel obstruction if taken without sufficient fluid [ , ].
However, these reports were about a guar gum product that is no longer available [ ]. In their meta-analysis, Pittler and colleagues concluded that given the adverse effects associated with the use of guar gum, the risks of taking it outweigh its benefits [ ].
Hoodia gordonii is a succulent plant that grows in the Kalahari Desert of southern Africa. The San people have traditionally used hoodia as an appetite suppressant during long hunts. This anecdotal evidence, combined with results of a few animal studies indicating that hoodia reduces food intake [ ], led to the widespread marketing of hoodia as a weight-loss supplement in the United States in the early s.
Scientists have not determined the exact mechanism whereby hoodia might suppress appetite. A glycoside commonly called P57, which may have central nervous system activity [ ], is widely believed to be the main active ingredient, although not all researchers agree [ 16 , ].
Despite its popularity as a weight-loss supplement, very little scientific research on hoodia has been conducted in humans [ ]. Compared to placebo, hoodia extract had no significant effect on energy intake or body weight.
Hoodia has been reported to cause significant increases in heart rate and blood pressure [ ]. It also raises bilirubin and alkaline phosphatase levels which may indicate impaired liver function , although the clinical significance of these findings is unclear because hoodia has not been reported to affect levels of other liver enzymes.
Other side effects include headache, dizziness, nausea, and vomiting. In the past, some hoodia products were found to contain little or no hoodia [ ]. The human microbiota, which outnumber human cells by up to fold, have myriad roles in human health [ , ].
Although microbes are found throughout the human body, the vast majority inhabit the colon. The gut microbiota play an important role in nutrient and energy extraction from food. Research in mice suggests that the gut microbiota affect not only use of energy from the diet but also energy expenditure and storage within the host [ ].
Whether these effects translate to humans is unknown. However, manipulating the gut microbiota has been proposed as a method to prevent or treat obesity in humans, and probiotics might provide a way to accomplish this. Probiotics are in foods, such as some yogurts, as well as dietary supplements.
The many different genera of probiotics include Lactobacillus, Streptococcus, and Bifidobacterium, which all have widely varying effects in the body [ , ].
Much of the research on probiotics and its influence on the gut microbiota and obesity has been in mice, and the results have been promising. For example, probiotic supplementation reduced body weight gain and fat accumulation in obese mice fed a high-fat diet [ ].
In humans, however, results of clinical trials that assessed the impact of probiotics on obesity-related endpoints have been inconsistent. In another randomized clinical trial, daily supplementation with 3.
However, among the 77 female participants, the Lactobacillus supplementation did significantly reduce body weight after 12 weeks loss of 1. Another recent systematic review and meta-analysis of 15 randomized controlled trials in individuals with overweight or obesity found that supplementation with various doses and strains of probiotics for 3 to 12 weeks resulted in larger reductions in body weight by 0.
However, these effects were small and of questionable clinical significance. The most recent systematic review and meta-analysis, which included 19 randomized trials in 1, participants, found that supplementation with probiotics or synbiotics products containing both probiotic organisms and prebiotic sugars, which microorganisms in the gastrointestinal tract use as metabolic fuel reduced waist circumference slightly by 0.
The findings from another meta-analysis of 14 trials in adults, 5 trials in children, and 12 trials in 1, infants suggested that probiotics promote an average loss of 0.
Taken together, these results indicate that the effects of probiotics on body weight and obesity might depend on several factors, including the probiotic strain, dose, and duration as well as certain characteristics of the user, including age, sex, and baseline body weight.
Additional research is needed to understand the potential effects of probiotics on body fat, body weight, and obesity in humans. Many probiotic strains derive from species with a long history of safe use in foods or from microorganisms that colonize healthy gastrointestinal tracts. For these reasons, the common probiotic species—such as Lactobacillus species acidophilus, casei, fermentum, gasseri, johnsonii, paracasei, plantarum, rhamnosus, and salivarius and Bifidobacterium species adolescentis, animalis, bifidum, breve, and longum —are unlikely to cause harm [ ].
Side effects of probiotics are usually minor and consist of self-limited gastrointestinal symptoms, such as gas. In a few cases, mainly involving individuals who were severely ill or immunocompromised, the use of probiotics has been linked to bacteremia, fungemia fungi in the blood , or infections that result in severe illness [ , ].
For individuals with compromised immune function or other serious underlying diseases, the World Gastroenterology Organisation advises restricting probiotic use to the strains and indications that have proven efficacy [ ]. Pyruvate is a three-carbon compound that is generated in the body through glycolysis [ ].
Pyruvate is also available as a dietary supplement, frequently in the form of calcium pyruvate. Researchers have suggested that pyruvate enhances exercise performance and reduces body weight and body fat, possibly by increasing lipolysis and energy expenditure [ 6 , , ]. Only a few studies have examined the effects of pyruvate supplementation in humans.
Although some of these studies suggest that pyruvate decreases body weight and body fat, others do not. At the end of the trial, the pyruvate group had significant decreases in body weight mean loss of 1. In the placebo group, these measurements did not change significantly compared to baseline. However, a double-blind, placebo-controlled trial in 23 women who were overweight mean BMI The authors of a systematic review and meta-analysis of six randomized controlled trials in a total of participants concluded that 5—30 g pyruvate for 3—6 weeks reduces body weight by a mean of 0.
However, the authors noted that the methodological quality of all trials is weak, preventing them from drawing firm conclusions. The safety of pyruvate has not been rigorously studied. Pyruvate might also increase LDL levels and decrease HDL levels [ , ]. Additional research is needed to better understand the safety and possible side effects of this compound.
Raspberry ketone is the primary aroma compound found in red raspberries Rubus idaeus , and it is added to some foods as a flavoring agent [ 16 , ].
In vitro and animal studies suggest that raspberry ketone might help prevent weight gain by increasing fatty acid oxidation, suppressing lipid accumulation, and inhibiting pancreatic lipase activity [ 16 ].
Although it has been touted on the Internet and national television as an effective way to burn fat, little evidence exists to support this claim.
In mice fed a high-fat diet, raspberry ketone supplementation reduced food intake and body weight compared to the same diet without raspberry ketone [ ]. Only one randomized controlled trial has examined the effects of a dietary supplement containing raspberry ketone on weight loss.
This product contained 2, mg of a proprietary blend of raspberry ketone, caffeine, bitter orange, ginger, garlic, cayenne, L-theanine, and pepper extract along with B-vitamins and chromium. During the 8-week study, participants followed a calorie-restricted diet approximately calories less per day than estimated needs and engaged in moderate exercise 60 minutes 3 days per week.
Compared to the placebo group, those receiving METABO lost significantly more body weight mean loss of 1. However, 25 of the 70 participants dropped out of the study, and results were reported for only the 45 participants who completed the study i. Furthermore, the product contained many ingredients in addition to raspberry ketone, making it impossible to determine the effects of raspberry ketone alone.
Typical diets provide only a few mg of raspberry ketone a day. Doses contained in dietary supplements typically range from to 1, mg, and the safety of such doses has never been evaluated in humans [ ].
Participants in the METABO study described above had no serious adverse effects [ ]. However, additional research on raspberry ketone is needed to better understand its safety and side effects. Vitamin D, which is fat soluble, is present in a few foods, such as fatty fish, cheese, egg yolks, and vitamin D-fortified milk.
It is also available in many dietary supplements, and humans synthesize it naturally when their skin is exposed to sunlight. Vitamin D promotes calcium absorption in the gastrointestinal tract and is needed for proper bone growth and remodeling [ 56 ]. Observational studies indicate that greater body weights are associated with lower vitamin D status, and individuals with obesity frequently have marginal or deficient circulating levels of vitamin D [ ].
Nevertheless, the association between vitamin D and obesity raises the question of whether increasing vitamin D concentrations might reduce body weight [ , ]. Despite the association between low vitamin D levels and obesity, scientific evidence does not support a cause-and-effect relationship.
The authors commented that the cause of this finding might have been stored vitamin D in body fat and skeletal muscle that was released during weight loss. However, according to a meta-analysis of 12 vitamin D supplementation trials including 5 in which body composition measurements were primary outcomes , vitamin D supplements without calorie restriction did not affect body weight or fat mass compared to placebo [ ].
Overall, the available research suggests that consuming higher amounts of vitamin D or taking vitamin D supplements does not promote weight loss. Protein Drink Mix: Chocolate g. Beverage Mix: Peach Mango g. Protein Baked Goods Mix.
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