Satiety and Glucose Indices in Adults
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 300mg SC 300 mg Salacia Chinensis (SC). This will be compared to placebo. |
Dietary Supplement: 300 mg SC
Salacia (T1) capsule given with breakfast (mixed meal tolerance test)
|
| Active Comparator: 500mg SC 500 mg Salacia Chinensis (SC). This will be compared to placebo. |
Dietary Supplement: 500 mg SC
Salacia (T2) capsule given with breakfast (mixed meal tolerance test)
|
| Placebo Comparator: Placebo 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
Placebo capsule given with breakfast (mixed meal tolerance test)
|
Outcome Measures
Primary Outcome Measures
- Appetite ratings (VAS) at either dose compared to placebo compared to placebo) [Change from Baseline and 3 hours]
Visual analog scale (VAS)
Secondary Outcome Measures
- Glucose indices (at either dose vs placebo) [Change from Baseline and 3 hours]
serum markers
- Taste perception (dose compared to placebo) [Change from Baseline and 3 hours]
visual analog scale
Other Outcome Measures
- Appetite regulating hormones and other markers at either dose or placebo [Change from Baseline and 3 hours]
blood
- Bone Turnover markers at either dose or placebo [Change from baseline over 3 hours]
blood
Eligibility Criteria
Criteria
Inclusion Criteria:
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BMI - overweight or stage 1 obesity
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Must be willing and able to visit the geographic vicinity of New Brunswick, NJ
Exclusion Criteria:
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(BP) [systolic BP> 140 and/or diastolic BP> 90]
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Fasting blood glucose >126
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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.
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History of chronic conditions and on prescription medication, surgery and or any treatment
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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
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History or presence of all cancers in the prior two years.
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Participation in a clinical study with exposure to any registered and non-registered drug product within 30 days prior.
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Pregnant or lactating women.
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Subjects who are currently on any weight loss diets, weight loss regimen
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Subjects currently taking prescription medication for hypertension, cardiovascular disease, diabetes and/or other chronic conditions.
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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.
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Subject has a known allergy or sensitivity to any ingredient in the test product.
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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.
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Subject has a history of difficulty swallowing large pills or tablets.
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Investigator is uncertain about subject's capability or willingness to comply with the protocol requirements.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rutgers University | New Brunswick | New Jersey | United States | 08901 |
Sponsors and Collaborators
- Rutgers University
- OmniActive Health Technologies
Investigators
- Principal Investigator: Sue Shapses, PhD, Rutgers University
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- Hao L, Schlussel Y, Fieselmann K, Schneider SH, Shapses SA. Appetite and Gut Hormones Response to a Putative α-Glucosidase Inhibitor, Salacia Chinensis, in Overweight/Obese Adults: A Double Blind Randomized Controlled Trial. Nutrients. 2017 Aug 12;9(8). pii: E869. doi: 10.3390/nu9080869.
- Ibrügger 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.
- 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.
- 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 α-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.
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