- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02537912
Blood Glucose and Body Fat Regulatory Effect of Peanut Skin Extract
February 1, 2019 updated by: You-Cheng Shen, Chung Shan Medical University
Effects of Peanut Skin Extract on Blood Glucose Regulation and Body Fat Reduction
The regulatory effects of the peanut skin extract (Sugarlock®) on body fat and blood glucose was demonstrated in a double-blind, placebo-controlled study. .
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Peanut skins, a by-product of peanut processing industry, is usually discarded as a waste in despite of the high content of phenolic compounds.
Polyphenol extract from peanut skins has been demonstrated to inhibit α-amylase activity in vitro.
Hence, the aim of this study was to evaluate the regulatory effects of the peanut skin extract on blood glucose and body fat by a double-blind, placebo-controlled, clinical study.
Subjects with simple obesity (body mass index [BMI] ≥ 27 or body fat ≥ 30%) ingested 4 Sugarlock® (n = 16) capsules or placebo (n = 14) a day for a total of 6 weeks.
Anthropometric measurements (body weight, body fat, blood pressure) and blood biochemical markers including fasting blood glucose (FBG), albumin, total cholesterol (TC), triglyceride (TG), HDL-C, LDL-C, creatinine (Cr), blood urea nitrogen (BUN), AST, ALT were examined every three weeks.
Also, 5 subjects were randomly selected for MRI scans to examine the distribution and thickness of abdominal fat layers before and after the trial.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
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 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults ages 20-70 years;
- Body mass index (BMI) ≥ 27 or body fat ≥ 30;
- No history of serious diseases associated with heart, liver, kidney, endocrine systems or other organs;
- No drugs consumption.
Exclusion Criteria:
- BMI >35;
- Alcoholic;
- US-controlled diabetics;
- Stoke in past one year;
- High blood pressure;
- Mental diseases or melancholia;
- Pregency or breast-feeding a child.
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: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Sugarlock®
Subjects ingested 2 capsules Sugarlock® (Experimental group) in the morning and 2 capsules in the evening (4 capsules/d) for a total of 6 weeks.
|
Subjects ingested 2 capsules (Experimental group) in the morning and 2 capsules in the evening (4 capsules/d) for a total of 6 weeks.
Anthropometric measurements such as body weight, body fat, waistline, hipline, blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) and blood biochemical parameters including FBG, albumin, TC, TG, HDL-C, LDL-C, Cr, BUN, AST and ALT were measured every three weeks.
Five subjects were randomly selected to take MRI abdominal scans before and after the trial.
After 6-week consumption, anthropometric measurements were examined on week 8 for a follow-up observation.
Other Names:
|
|
Placebo Comparator: Placebo
Subjects ingested 2 capsules placebo (Control group) in the morning and 2 capsules in the evening (4 capsules/d) for a total of 6 weeks.
|
Subjects ingested 2 capsules placebo in the morning and 2 capsules in the evening (4 capsules/d) for a total of 6 weeks.
Anthropometric measurements such as body weight, body fat, waistline, hipline, blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) and blood biochemical parameters including FBG, albumin, TC, TG, HDL-C, LDL-C, Cr, BUN, AST and ALT were measured every three weeks.
Five subjects were randomly selected to take MRI abdominal scans before and after the trial.
After 6-week consumption, anthropometric measurements were examined on week 8 for a follow-up observation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The changes of body fat of the subjects.
Time Frame: 6 weeks
|
values change of body fat (%) between before to after 6 weeks
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The changes of fasting blood glucose (FBG) of the subjects
Time Frame: 6 weeks
|
values change of fasting blood glucose (FBG) between before to after 6 weeks
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- Grussu D, Stewart D, McDougall GJ. Berry polyphenols inhibit alpha-amylase in vitro: identifying active components in rowanberry and raspberry. J Agric Food Chem. 2011 Mar 23;59(6):2324-31. doi: 10.1021/jf1045359. Epub 2011 Feb 17.
- McDougall GJ, Shpiro F, Dobson P, Smith P, Blake A, Stewart D. Different polyphenolic components of soft fruits inhibit alpha-amylase and alpha-glucosidase. J Agric Food Chem. 2005 Apr 6;53(7):2760-6. doi: 10.1021/jf0489926.
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
December 1, 2013
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
August 23, 2015
First Submitted That Met QC Criteria
August 30, 2015
First Posted (Estimate)
September 2, 2015
Study Record Updates
Last Update Posted (Actual)
February 4, 2019
Last Update Submitted That Met QC Criteria
February 1, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CS13167
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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