NCT02537912

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. .

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Dec 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 2, 2015

Completed
Last Updated

February 4, 2019

Status Verified

February 1, 2019

Enrollment Period

8 months

First QC Date

August 23, 2015

Last Update Submit

February 1, 2019

Conditions

Obesity

Keywords

peanut skinbody fatblood glucosewaistlinebody weight

Outcome Measures

Primary Outcomes (1)

  • The changes of body fat of the subjects.

    values change of body fat (%) between before to after 6 weeks

    6 weeks

Secondary Outcomes (1)

  • The changes of fasting blood glucose (FBG) of the subjects

    6 weeks

Study Arms (2)

Sugarlock®

ACTIVE COMPARATOR

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.

Dietary Supplement: Sugarlock®

Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Interventions

Sugarlock®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.

Also known as: peanut skin
Sugarlock®
PlaceboDIETARY_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.

Placebo

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • BMI \>35;
  • Alcoholic;
  • US-controlled diabetics;
  • Stoke in past one year;
  • High blood pressure;
  • Mental diseases or melancholia;
  • Pregency or breast-feeding a child.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 21329358BACKGROUND

  • 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.

    PMID: 15796622BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Conditions

ObesityBody Weight

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • You-Cheng Mr Shen, Ph.D.

    Chung Shan Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
School of Health Diet and Industry Managment

Study Record Dates

First Submitted

August 23, 2015

First Posted

September 2, 2015

Study Start

December 1, 2013

Primary Completion

August 1, 2014

Study Completion

June 1, 2015

Last Updated

February 4, 2019

Record last verified: 2019-02