Satiety and Glucose Indices in Adults
May 8, 2026 updated by: Sue A. Shapses, Ph.D., RD, Rutgers University
Influence of Herb With Alpha-glucosidase Properties (Salacia Chinensis) on Appetite, Glucose and Hormonal Factors: A Double Blind Randomized Placebo Controlled-crossover Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
51
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
New Brunswick, New Jersey, United States, 08901
- Rutgers University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 59 years (Adult)
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 300mg SC
300 mg Salacia Chinensis (SC).
This will be compared to placebo.
|
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.
|
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.
|
Placebo capsule given with breakfast (mixed meal tolerance test)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Appetite ratings (VAS) at either dose compared to placebo compared to placebo)
Time Frame: Change from Baseline and 3 hours
|
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)
Time Frame: Change from Baseline and 3 hours
|
serum markers
|
Change from Baseline and 3 hours
|
|
Taste perception (dose compared to placebo)
Time Frame: Change from Baseline and 3 hours
|
visual analog scale
|
Change from Baseline and 3 hours
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Appetite regulating hormones and other markers at either dose or placebo
Time Frame: Change from Baseline and 3 hours
|
blood
|
Change from Baseline and 3 hours
|
|
Bone Turnover markers at either dose or placebo
Time Frame: Change from baseline over 3 hours
|
blood
|
Change from baseline over 3 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sue Shapses, PhD, Rutgers University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.1038/sj.ijo.0801083.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2015
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
January 1, 2017
Study Registration Dates
First Submitted
August 16, 2016
First Submitted That Met QC Criteria
October 10, 2016
First Posted (Estimated)
October 11, 2016
Study Record Updates
Last Update Posted (Actual)
May 13, 2026
Last Update Submitted That Met QC Criteria
May 8, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10420 (Fred Hutch/University of Washington Cancer Consortium)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
rules/regulations would need to be confirmed
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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