Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
51 participants
INTERVENTIONAL
2015-08-31
2021-01-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
TRIPLE
Study Groups
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300mg SC
300 mg Salacia Chinensis (SC). This will be compared to placebo.
300 mg SC
Salacia (T1) capsule given with breakfast (mixed meal tolerance test)
500mg SC
500 mg Salacia Chinensis (SC). This will be compared to placebo.
500 mg SC
Salacia (T2) capsule given with breakfast (mixed meal tolerance test)
Placebo
The investigators will examine subjects before and during a 3 hour period after subjects consume a Placebo capsule and a fixed breakfast meal.
Placebo
Placebo capsule given with breakfast (mixed meal tolerance test)
Interventions
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300 mg SC
Salacia (T1) capsule given with breakfast (mixed meal tolerance test)
500 mg SC
Salacia (T2) capsule given with breakfast (mixed meal tolerance test)
Placebo
Placebo capsule given with breakfast (mixed meal tolerance test)
Eligibility Criteria
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Inclusion Criteria
* Must be willing and able to visit the geographic vicinity of New Brunswick, NJ
Exclusion Criteria
* 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.
20 Years
59 Years
ALL
Yes
Sponsors
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OmniActive Health Technologies
INDUSTRY
Rutgers University
OTHER
Responsible Party
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Sue A. Shapses, Ph.D., RD
Professor
Principal Investigators
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Sue Shapses, PhD
Role: PRINCIPAL_INVESTIGATOR
Rutgers University
Locations
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Rutgers University
New Brunswick, New Jersey, United States
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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10420
Identifier Type: -
Identifier Source: org_study_id
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