Blood Glucose and Body Fat Regulatory Effect of Peanut Skin Extract

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: Sugarlock®; Dietary Supplement: Placebo

• Registration Number: NCT02537912
• Lead Sponsor: Chung Shan Medical University

Brief Summary

The regulatory effects of the peanut skin extract (Sugarlock®) on body fat and blood glucose was demonstrated in a double-blind, placebo-controlled study. .

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 Timeline

• Study Start: 2013-12
• Primary Completion: 2014-08
• Study Completion: 2015-06
• Study First Submitted: 2015-08-23
• Study First Submitted QC: 2015-08-30
• Study First Posted: 2015-09-02
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugarlock®	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.
Placebo	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.

Primary Outcome Measures

Name	Time	Method
The changes of body fat of the subjects.	6 weeks	values change of body fat (%) between before to after 6 weeks

Secondary Outcome Measures

Name	Time	Method
The changes of fasting blood glucose (FBG) of the subjects	6 weeks	values change of fasting blood glucose (FBG) between before to after 6 weeks