Satiety and Glucose Indices in Adults

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: 500 mg SC; Dietary Supplement: 300 mg SC

• Registration Number: NCT02929849
• Lead Sponsor: Rutgers University

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.

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 Timeline

• Study Start: 2015-08
• Primary Completion: 2016-06
• Study First Submitted: 2016-08-16
• Study First Submitted QC: 2016-10-10
• Study First Posted: 2016-10-11
• Study Completion: 2021-01-30
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-28
• Last Update Posted: 2022-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	The investigators will examine subjects before and during a 3 hour period after subjects consume a Placebo capsule and a fixed breakfast meal.
500mg SC	500 mg SC	500 mg Salacia Chinensis (SC). This will be compared to placebo.
300mg SC	300 mg SC	300 mg Salacia Chinensis (SC). This will be compared to placebo.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Taste perception (dose compared to placebo)	Change from Baseline and 3 hours	visual analog scale
Glucose indices (at either dose vs placebo)	Change from Baseline and 3 hours	serum markers

Trial Locations

Locations (1)

Rutgers University; 🇺🇸 New Brunswick, New Jersey, United States