Blood Glucose and Body Fat Regulatory Effect of Peanut Skin Extract

NCT ID: NCT02537912

Last Updated: 2019-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-06-30

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Sugarlock®

Intervention Type: DIETARY_SUPPLEMENT

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.

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

Sugarlock®

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

peanut skin

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chung Shan Medical University

OTHER

Sponsor Role: lead

Responsible Party

You-Cheng Shen

School of Health Diet and Industry Managment

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

You-Cheng Mr Shen, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Chung Shan Medical University

References

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.

Reference Type: BACKGROUND

PMID: 21329358 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15796622 (View on PubMed)

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.

Reference Type: BACKGROUND

Other Identifiers

CS13167

Identifier Type: -

Identifier Source: org_study_id