Clinical trial NCT02537912: Blood Glucose and Body Fat Regulatory Effect of Peanut Skin Extract
Official title: Effects of Peanut Skin Extract on Blood Glucose Regulation and Body Fat Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: peanut skin
body fat
blood glucose
waistline
body weight
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2015-09-02
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The changes of body fat of the subjects.
timeFrame: 6 weeks
Secondary outcomes:
measure: The changes of fasting blood glucose (FBG) of the subjects
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Chung Shan Medical University
name: You-Cheng Mr Shen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Yu Y, Gao F, Deng X, Pu X, Zhang M, Pang Y. Inhibitory effect of polyphenol extracts from peanut shells on the activity of pancreatic α-amylase activity in vitro. J Food Agric Environ. 2013; 11: 38-42.J Agric Food Chem. 2005; 53: 2760-2766.