CompletedPhase 2Phase 3ACTRN12612000198820

21 day trial into the weight reduction effects of supplementation with 1g and 500mg SolaThin.

21 day trial into the weight reduction effects of supplementation with 1g and 500mg SolaThin in adults aged between 18 and 40 with a Body Mass Index (BMI) of over 30.


Sponsor

CYVEX NUTRITION, INC

Enrollment

60 participants

Start Date

Apr 16, 2012

Study Type

Interventional

Conditions

Summary

The current study aims to investigate the potential appetite suppressing, mood enhancing and weight loss effects of protease inhibitor PI-2 found in a potato protein extract (SolaThin). The study will utilize pre and post supplementation scale measurements of appetite, mood, energy intake, CCK and morphometric data to assess the effect of 21 day supplementation of SolaThin.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 40 Yearss

Plain Language Summary

Simplified for easier understanding

This 21-day trial tests whether SolaThin, a plant-based supplement, helps with weight reduction in otherwise healthy obese adults aged 18-40 (BMI over 30). Participants take either 1g or 500mg of SolaThin or a placebo daily. The study measures changes in appetite, body weight, and food intake to determine if the supplement is effective for weight management.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

SolaThin is an extract of pure potato protein consisting of several low molecular weight proteins, including protease inhibitor PI-2. It has been suggested that certain protease inhibitor fractions ma

SolaThin is an extract of pure potato protein consisting of several low molecular weight proteins, including protease inhibitor PI-2. It has been suggested that certain protease inhibitor fractions may lead to a reduction in food intake via modulation of Cholecystokinin (CCK) levels. On the testing days participants will have weight, height and body measurements recorded and complete baseline mood and appetite questionnaires. Participants will then consume one beverage pre-prepared by the investigator containing SolaThin Supplement or matching placebo. 20 minutes after the consumption of the treatment participants will complete the mood and appetite questionnaires again and have a series of blood tests taken. At the end of testing day one, participants will be given their 21 day allotment of beverages containing the same treatment as the testing day and counselled on the appropriate way to consume the beverages. Participants will be required to consume the beverage 20 minutes before all main meals (three times a day) for the 21 days. Testing day two will be the same as testing day one however participants will also have energy intake measured (assessed by analysis of buffet food intake) The 3 treatments are: - 500mg SolaThin (see details below) - 1g SolaThin (see details below) - Placebo (matched for taste and appearance) Beverages will consist of 200 ml water mixed with one sachet of treatment. SolaThin Nutritional Analysis NUTRIENTS PER 1 gram of SolaThin trademark TOTAL CARBOHYDRATE 14 mg PROTEIN, 6.25 factor 946 mg SODIUM 1.87 mg IRON 0.004 mg Amino Acids (g) Per 100 Grams Alanine 2.79 Arginine <0.10 Aspartic Acid 12.17 Cysteine 0.34 Cystine 0.12 Glutamic Acid 7.16 Glutamine 0.18 Glycine 5.14 Histidine 1.68 Isoleucine 7.91 Leucine 7.96 Lysine 12.51 Methionine 1.99 Phenylalanine 1.24 Proline 4.82 Serine 5.55 Threonine 4.70 Tryptophan 1.89 Tyrosine 5.23 Valine <0.10 Minerals Per 100 Grams Calcium 8.2 mcg Cobalt 1.2 mcg Copper 1.7 mcg Iron 546.3 mcg Magnesium 3.53 mg Manganese 124.0 mcg Phosphorus 3.0 mg Potassium 6.0 mcg Selenium 210.2 mcg Sodium 40.5 mg Zinc 2.4 mg Vitamins Per 10 Grams Beta-Carotene 34.0 IU Biotin (B7) 8.2 mcg Choline 3.8 mg Pyrodixie (B6) 40 mcg Riboflavin (B2) 460 mcg Thiamin (B) 3.2 mcg Vitamin E 0.47 IU Vitamin K 4.3 mcg


Locations(1)

VIC, Australia

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ACTRN12612000198820