None listed
Conditions
Brief 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.
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 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 inves
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
Sponsors
CYVEX NUTRITION, INC
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
Participants who meet the following eligibility criteria will be recruited in the trial: 1. Males and females aged 18-40 with Body Mass Index (BMI) >30, otherwise healthy. 2. Are comfortable with computers and willing and able to participate in all scheduled visits, treatment plan, tests and other trial procedures according to the protocol. 3. Are comfortable with taking a daily supplement of SolaThin or Placebo for 21 days. 4. Provide a personally signed and dated informed consent indicating that the participant has been informed of all pertinent aspects of the trial.
Exclusion criteria
Participants presenting with any of the following will not be included in the trial: 1. History of anxiety, depression, psychiatric disorders. 2. History of / do not currently suffer from heart disease or high blood pressure or diabetes 3. Taking any medication, herbal extracts, vitamin supplements or illicit drugs for 4 weeks prior to (and duration of) study 4. Taking any form of medication within 5 days of admission (except for prophylactic antibiotics, or other routine medications to treat benign conditions, such as antibiotics to treat acne) and agree not to take any medication throughout the study 5. Health conditions that would affect food metabolism including the following: food allergies, kidney disease, liver disease and/or gastrointestinal diseases (e.g. Irritable bowel syndrome, coeliac disease, peptic ulcers) 6. Renal function problems, Hypercalcaemia; Hypermagnesemia, Severe hypercalciuria, phenylketonuria (autosomal metabolic disorder), 7. Currently pregnant or lactating
Outcome results
None listed