Appetite Suppressant Study

At Ethical, we’re proud to be honest and transparent with our products and what’s in them. And we’re happy to share our Appetite Suppressant study with you.

1. SUPPLEMENT FACTS

Supplement Facts Serving Size: 1 mini tabletServings Per Container: 150
Amount Per Serving		%Daily Value
Gotu Kola extract (Herb)	11.7 mg	†
Dandelion extract  (Root)	11.7 mg	†
Griffonia extract  (Seed)Providing 9.728 mg 5-HTP	10.24 mg	†
Globe Artichoke extract  (Leaf)	9.75 mg	†
Guarana extract  (Seed)	4.55 mg	†
Klamath Algae powder (Thallus)	39 mcg	†
† Daily Value not established.

Other ingredients: TBD.

2. DIRECTIONS

Allow one mini tablet to dissolve in your mouth before swallowing. Take 30 minutes before breakfast, lunch and dinner. Also do the same between breakfast and lunch, and again between lunch and dinner for a total of 5 mini tablets daily. 

3. CLAIMS

Claim	Substantiation
Shown in two clinical studies to significantly decrease appetite compared to placebo.*	5-HTP study 1-2
In a clinical study, resulted in a 32.8% decrease in binge eating scores.*	5-HTP study 2
In a clinical study, resulted in a 27.2% improvement in satiety scores.*	5-HTP study 2
Shown in two clinical studies to help reduce waist size more than diet and exercise alone.*	5-HTP study 1-2
Shown in two clinical studies to help reduce hip size more than diet and exercise alone.*	5-HTP study 1-2
Shown in two clinical studies to help reduce BMI more than diet and exercise alone.*	5-HTP study 1-2

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

4. SUBSTANTIATION STUDIES

Note 2: Serotonin is a neurotransmitter with many functions in the body.  One of those functions is that it can help to reduce appetite.  In fact, in the pharmaceutical market, the role of serotonin in appetite control and satiety (which means the state of being satisfactorily full and unable to eat more) is well established and is the basis for selective serotonin reuptake inhibitor (SSRI) medications which increase serotonin levels and help reduce food intake. 

5-HTP, or 5-hydroxytryptophan, is a type of amino acid. In the body, 5-HTP is converted into serotonin. In fact, 5-HTP readily crosses the blood-brain barrier and increases central nervous system (CNS) production of serotonin.  And once the serotonin is produced it helps reduce hunger pangs. This is possible because there are numerous types of serotonin receptors in the brain, and two of them (called 5-HT1B and 5-HT2C) have been specifically recognized as promoting serotonin-induced satiety.

5-HTP study 1

The fourth randomized, double-blind, placebo-controlled study took place in 2009, lasted for two months, and included 27 healthy, overweight women. This study used a spray delivery system designed to be absorbed in the mouth and under the tongue (sublingual), rather than a tablet or capsule which must be swallowed. Researchers speculated that the sublingual delivery system would have better absorption than standard pills and would require a far lower dose than used in other studies (see studies 3 through 5 listed below). Another difference from other studies was that the sublingual delivery system used a few other herbs in addition to Griffonia simplicifolia (as the source of 5-HTP):

Gotu Kola extract (Herb) 11.7 mg

Dandelion extract (Root) 11.7 mg

Griffonia extract  (Seed) 10.24 mg

Providing 9.728 mg 5-HTP

Globe Artichoke extract (Leaf) 9.75 mg

Guarana extract (Seed) 4.55 mg

Klamath Algae powder (Thallus) 39 mcg

The sublingual mix of herbs was used five times daily (before breakfast, lunch and dinner, and between meals). The results were that, compared to placebo, the 5HTP group experienced a significantly greater increase in their sensation of satiety. Specifically, there was 32.8% decrease in binge eating scores, and a 27.2% improvement in satiety scores. In addition, 5-HTP subjects lost 1.02 points off their BMI, 0.64 inches off their waist, and 1.06 inches off their hips. Additionally the study showed that the 5-HTP was effective absorbed in the sublingual form. Also, the sublingual mix of herbs was well tolerated, and there were no serious adverse events over the 8 weeks of the study—including nausea which occurred with higher 5-HTP doses in studies 3 through 5.

5-HTP study 2

The fifth randomized, double-blind, placebo-controlled study took place in 2012, lasted for four weeks, and included 20 healthy, overweight women. The same aforementioned sublingual mix of herbs was used five times daily. In addition, all subjects (5-HTP and placebo groups) were trained to reduce their daily calorie intake by about 800 calories daily (e.g. if they were previously eating 2500 calories, they would now eat 1700 calories), while maintaining a prudent caloric balance of 25% fat, 60% carbohydrates and 15% protein. A registered dietician performed initial dietary counselling. The results were that the 5HTP group experienced a significant decrease in appetite compared to placebo. They also lost 2.49 lbs, 0.89 points off their BMI, 0.95 inches off their waist, and 2.3 inches off their hips. As with the fourth study, no adverse events were reported.

Note 3: The following studies use much higher doses of 5-HTP than are used in this formulation. Nevertheless, summaries of these studies are included to demonstrate the larger body of research on 5-HTP for reducing appetite and promoting satiety.

In addition, these studies showed a significant number of the subjects taking these higher doses of 5-HTP reported mild periodic nausea which was significantly reduced as the studies progressed. This suggests that this symptom may be considered a temporary effect of 5-HTP administration. In each case, the mild nausea was not severe enough to cause any subjects to drop out of the study.  Nevertheless, nausea—however mild—is not a particularly desirable side effect.  That’s what the data from the prior two studies particularly interesting.

5-HTP study 3

This study took place in 1989. Nineteen obese female subjects with body mass index ranging between 30 and 40 (which means they were significantly obese) were included in a double-blind crossover study aimed at evaluating the effects of oral 5-HTP on feeding behavior, mood state and weight loss. Either 5-HTP (8 mg/kg/day, which would be 544 mg for a 150 lb woman) or placebo was administered for five weeks during which patients were not prescribed any dietary restrictions. The subjects took capsules of 5-HTP 30 minutes before each of three daily meals. The results were that 5-HTP resulted in no changes in mood state but reduced appetite, decreased food intake and promoted weight loss during the period of observation.  Specifically, subjects reduced their daily calorie intake by 37% (from 2903 to 1819 calories) and ate about 98 grams less carbohydrate per day when using 5-HTP.  Likewise, subjects lost about 3.3 lbs when using 5-HTP, compared to only about 1 lb lost while using a placebo.

5-HTP study 4

This study took place in 1992. Twenty obese patients were randomly assigned to receive either 5-HTP (900 mg/day) or a placebo. The study was double-blinded and was for two consecutive six-week periods. No diet was prescribed during the first period, but a 1200 calorie per day diet was recommended for the second. The results were that 100% and 90% of obese subjects receiving 900 mg 5-HTP daily during two consecutive six-week study periods, respectively, reported early satiety (that is, they felt fuller sooner). The reduction in appetite was further reflected in the fact that during the first study period, the 5-HTP group reduced their daily calorie intake by 42% (from 3233 to1886 calories).  During the second study period, the 5-HTP group further reduced their calories by a total of 61% compared to the beginning of the first period (from 3233 to 1273 calories). A reduction in carbohydrate intake and a consistent presence of early satiety were also found. The placebo group experienced no significant reduction in daily calorie intake during the first or second study periods. 

Significant weight loss was observed in 5-HTP-treated patients during both periods. The 5-HTP group lost about 4 lbs during the first study period, and another 7 lbs during the second study period. The total weight loss is equivalent to 5% of their starting body weight. Subjects receiving the placebo did not show any significant change in their body weight during either study period. These findings, together with the good tolerance observed, suggest that 5-HTP may be safely used to treat obesity.

5-HTP study 5

The third study took place in 1998. Twenty-five overweight non-insulin dependent diabetic outpatients were enrolled in a double-blind, placebo-controlled study, and randomized to receive either 5-HTP (750 mg/day) or placebo for two consecutive weeks, during which no dietary restriction was prescribed. Calorie intake and eating behavior were evaluated using a daily diet diary. All 20 patients (nine from the 5-HTP group and 11 from the placebo group) completed the study. Patients receiving 5-HTP significantly reduced their daily calorie intake by 21% (from 1933 to 1527 calories) over a period of two weeks. This calorie reduction was the result of a decreased intake of carbohydrates and fats. The placebo group experienced no significant reduction in daily calorie intake. The 5-HTP group also lost 5 lbs during two weeks (from 190 to 185 lbs). Subjects receiving the placebo did not show any significant change in their body weight.

References:

1. Halford JC, Harrold JA, Boyland EJ, Lawton CL, Blundell JE. Serotonergic drugs : effects on appetite expression and use for the treatment of obesity. Drugs 2007;67(1):27-55.
2. Shaw K, Turner J, Del Mar C. Tryptophan and 5-hydroxytryptophan for depression. Cochrane Database Syst Rev 2002;(1):CD003198.
3. Halford JC, Harrold JA, Boyland EJ, Lawton CL, Blundell JE. Serotonergic drugs: effects on appetite expression and use for the treatment of obesity. Drugs 2007;67(1):27-55.
4. Rondanelli M, Klersy C, Iadarola P, Monteferrario F, Opizzi A. Satiety and amino-acid profile in overweight women after a new treatment using a natural plant extract sublingual spray formulation. Int J Obes (Lond). 2009 Oct;33(10):1174-82.
5. Rondanelli M, Opizzi A, Faliva M, Bucci M, Perna S. Relationship between the absorption of 5-hydroxytryptophan from an integrated diet, by means of Griffonia simplicifolia extract, and the effect on satiety in overweight females after oral spray administration. Eat Weight Disord. 2012 Mar;17(1):e22-8.
6. Ceci F, Cangiano C, Cairella M, Cascino A, Del Ben M, Muscaritoli M, Sibilia L, Rossi Fanelli F. The effects of oral 5-hydroxytryptophan administration on feeding behavior in obese adult female subjects.J Neural Transm 1989;76(2):109-17.
7. Cangiano C, Ceci F, Cascino A, Del Ben M, Laviano A, Muscaritoli M, Antonucci F, Rossi-Fanelli F. Eating behavior and adherence to dietary prescriptions in obese adult subjects treated with 5-hydroxytryptophan. Am J Clin Nutr 1992;56(5):863-7.
8. Cangiano C, Laviano A, Del Ben M, Preziosa I, Angelico F, Cascino A, Rossi- Fanelli F. Effects of oral 5-hydroxy-tryptophan on energy intake and macronutrient selection in non-insulin dependent diabetic patients. Int J Obes Relat Metab Disord 1998;22(7):648-54.