Satiety and Glucose Indices in Adults

NCT02929849 | Completed DMC

• 1 other identifier: 10420
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Appetite ratings (VAS) at either dose compared to placebo compared to placebo)

  Visual analog scale (VAS)

  Change from Baseline and 3 hours

Secondary Outcomes (2)

• Glucose indices (at either dose vs placebo)

  Change from Baseline and 3 hours

• Taste perception (dose compared to placebo)

  Change from Baseline and 3 hours

Other Outcomes (2)

• Appetite regulating hormones and other markers at either dose or placebo

  Change from Baseline and 3 hours

• Bone Turnover markers at either dose or placebo

  Change from baseline over 3 hours

Study Arms (3)

300mg SC

EXPERIMENTAL

300 mg Salacia Chinensis (SC). This will be compared to placebo.

Dietary Supplement: 300 mg SC

500mg SC

ACTIVE COMPARATOR

500 mg Salacia Chinensis (SC). This will be compared to placebo.

Dietary Supplement: 500 mg SC

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.

Dietary Supplement: Placebo

Interventions

300 mg SC DIETARY_SUPPLEMENT

Salacia (T1) capsule given with breakfast (mixed meal tolerance test)

300mg SC

500 mg SC DIETARY_SUPPLEMENT

Salacia (T2) capsule given with breakfast (mixed meal tolerance test)

500mg SC

Placebo DIETARY_SUPPLEMENT

Placebo capsule given with breakfast (mixed meal tolerance test)

Placebo

Eligibility Criteria

• Age: 20 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI - overweight or stage 1 obesity
• Must be willing and able to visit the geographic vicinity of New Brunswick, NJ

You may not qualify if:

• (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.

Sponsors & Collaborators

• Rutgers University: lead
• OmniActive Health Technologies: collaborator

Study Sites (1)

Rutgers University

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (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.

  PMID: 22237063 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.

  PMID: 10702749 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.

  PMID: 22245724 BACKGROUND

• 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.

  PMID: 28805670 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.

  PMID: 33432459 RESULT

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sue Shapses, PhD

  Rutgers University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 16, 2016
• First Posted: October 11, 2016
• Study Start: August 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: January 1, 2017
• Last Updated: May 13, 2026

Record last verified: 2026-05

Locations

US (1)