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| Name | Class |
|---|---|
| OmniActive Health Technologies | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 300mg SC | Experimental | 300 mg Salacia Chinensis (SC). This will be compared to placebo. |
|
| 500mg SC | Active Comparator | 500 mg Salacia Chinensis (SC). This will be compared to placebo. |
|
| Placebo | Placebo Comparator | The investigators will examine subjects before and during a 3 hour period after subjects consume a Placebo capsule and a fixed breakfast meal. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 300 mg SC | Dietary Supplement | Salacia (T1) capsule given with breakfast (mixed meal tolerance test) |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Appetite regulating hormones and other markers at either dose or placebo | blood | Change from Baseline and 3 hours |
| Bone Turnover markers at either dose or placebo | blood |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sue Shapses, PhD | Rutgers University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers University | New Brunswick | New Jersey | 08901 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22237063 | Background | Kissileff HR, Thornton JC, Torres MI, Pavlovich K, Mayer LS, Kalari V, Leibel RL, Rosenbaum M. Leptin reverses declines in satiation in weight-reduced obese humans. Am J Clin Nutr. 2012 Feb;95(2):309-17. doi: 10.3945/ajcn.111.012385. Epub 2012 Jan 11. | |
| 10702749 | Background | Flint A, Raben A, Blundell JE, Astrup A. Reproducibility, power and validity of visual analogue scales in assessment of appetite sensations in single test meal studies. Int J Obes Relat Metab Disord. 2000 Jan;24(1):38-48. doi: 10.1038/sj.ijo.0801083. |
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rules/regulations would need to be confirmed
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 500 mg SC | Dietary Supplement | Salacia (T2) capsule given with breakfast (mixed meal tolerance test) |
|
| Placebo | Dietary Supplement | Placebo capsule given with breakfast (mixed meal tolerance test) |
|
| Change from Baseline and 3 hours |
| Change from baseline over 3 hours |
| 22245724 | Background | Ibrugger S, Kristensen M, Mikkelsen MS, Astrup A. Flaxseed dietary fiber supplements for suppression of appetite and food intake. Appetite. 2012 Apr;58(2):490-5. doi: 10.1016/j.appet.2011.12.024. Epub 2012 Jan 5. |
| 28805670 | Result | Hao L, Schlussel Y, Fieselmann K, Schneider SH, Shapses SA. Appetite and Gut Hormones Response to a Putative alpha-Glucosidase Inhibitor, Salacia Chinensis, in Overweight/Obese Adults: A Double Blind Randomized Controlled Trial. Nutrients. 2017 Aug 12;9(8):869. doi: 10.3390/nu9080869. |
| 33432459 | Result | Kreitman A, Schneider SH, Hao L, Schlussel Y, Bello NT, Shapses SA. Reduced postprandial bone resorption and greater rise in GLP-1 in overweight and obese individuals after an alpha-glucosidase inhibitor: a double-blinded randomized crossover trial. Osteoporos Int. 2021 Jul;32(7):1379-1386. doi: 10.1007/s00198-020-05791-5. Epub 2021 Jan 11. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |