Satiety and Glucose Indices in Adults

NCT ID: NCT02929849

Last Updated: 2022-02-14

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2021-01-30

Brief Summary

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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

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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300mg SC

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

Group Type EXPERIMENTAL

300 mg SC

Intervention Type DIETARY_SUPPLEMENT

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

500mg SC

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

Group Type ACTIVE_COMPARATOR

500 mg SC

Intervention Type DIETARY_SUPPLEMENT

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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)

Intervention Type DIETARY_SUPPLEMENT

500 mg SC

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo capsule given with breakfast (mixed meal tolerance test)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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OmniActive Health Technologies

INDUSTRY

Sponsor Role collaborator

Rutgers University

OTHER

Sponsor Role lead

Responsible Party

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Sue A. Shapses, Ph.D., RD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

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.

Reference Type BACKGROUND
PMID: 22237063 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10702749 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22245724 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28805670 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33432459 (View on PubMed)

Other Identifiers

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10420

Identifier Type: -

Identifier Source: org_study_id

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