Satiety and Glucose Indices in Adults

Study Overview
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Brief Summary
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The purpose of this study is to determine whether an herb with known alpha-glucosidase inhibitor properties (Salacia Chinensis, SC), affects postprandial appetite ratings and glucose indices in overweight/obese individuals.

Detailed Description
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Subjects are randomly assigned (double blinded) to 300 mg SC, 500 mg SC or placebo using a cross-over design on three different days (1 month wash out). Subjects consuming a capsule containing placebo or treatment(s) are examined before and after a fixed breakfast meal (50% carbohydrate; 30% fat; 20% protein). Subjective appetite sensations are rated using visual analog scales (VAS) for hunger, satiety, fullness, and prospective food intake. In addition, the desire for specific tastes is analyzed and measurements are taken twice before breakfast (fasting baseline). After baseline screening and blood draw, postprandial appetite and taste perception ratings and blood will be obtained at multiple time points during the 3 hour postprandial period (30, 60, 90, 120,180 min). Blood will be analyzed for glucose/insulin, gut peptides, and other markers in response to the meal.

Official Title
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Influence of Herb With Alpha-glucosidase Properties (Salacia Chinensis) on Appetite, Glucose and Hormonal Factors: A Double Blind Randomized Placebo Controlled-crossover Trial

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: 300 mg SC
* Dietary Supplement: 500 mg SC
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI - overweight or stage 1 obesity Must be willing and able to visit the geographic vicinity of New Brunswick, NJ Exclusion Criteria: (BP) [systolic BP> 140 and/or diastolic BP> 90] Fasting blood glucose >126 Subject has a significant history or current presence of treated or untreated bleeding disorder, diabetes mellitus, thyroid disease, tachyarrhythmia, heart disease, kidney disease, or liver disease. History of chronic conditions and on prescription medication, surgery and or any treatment Any significant GI condition that would severely interfere with the evaluation of the study product including but not limited to inflammatory bowel disease (Ulcerative Colitis or Crohn's), history of frequent diarrhea, history of surgery for weight loss (including gastric bypass or lapband), history of perforation of the stomach or intestines, gastroparesis, clinically important lactose intolerance History or presence of all cancers in the prior two years. Participation in a clinical study with exposure to any registered and non-registered drug product within 30 days prior. Pregnant or lactating women. Subjects who are currently on any weight loss diets, weight loss regimen Subjects currently taking prescription medication for hypertension, cardiovascular disease, diabetes and/or other chronic conditions. Subject currently suffers from a sleep disorder and/or has a known history of (or is currently being treated for) clinical depression, eating disorder(s) or any other psychiatric condition(s), which in the opinion of the investigator, might put the subject at risk and/or confound the results of the study. Subject has a known allergy or sensitivity to any ingredient in the test product. Subject has any medical condition or uses any medication, nutritional product, dietary supplement or program, which in the opinion of the investigator, might interfere with the conduct of the study or place the subject at risk. Subject has a history of difficulty swallowing large pills or tablets. Investigator is uncertain about subject's capability or willingness to comply with the protocol requirements.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 300mg SC<br>300 mg Salacia Chinensis (SC). This will be compared to placebo. | Dietary Supplement: 300 mg SC<br>* Salacia (T1) capsule given with breakfast (mixed meal tolerance test)<br>|
| Active Comparator: 500mg SC<br>500 mg Salacia Chinensis (SC). This will be compared to placebo. | Dietary Supplement: 500 mg SC<br>* Salacia (T2) capsule given with breakfast (mixed meal tolerance test)<br>|
| Placebo Comparator: Placebo<br>The investigators will examine subjects before and during a 3 hour period after subjects consume a Placebo capsule and a fixed breakfast meal. | Dietary Supplement: Placebo<br>* Placebo capsule given with breakfast (mixed meal tolerance test)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appetite ratings (VAS) at either dose compared to placebo compared to placebo) | Visual analog scale (VAS) | Change from Baseline and 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose indices (at either dose vs placebo) | serum markers | Change from Baseline and 3 hours | 
| Taste perception (dose compared to placebo) | visual analog scale | Change from Baseline and 3 hours |