Resistant Starch, Antioxidant Status and Insulin Resistance

August 14, 2015 updated by: Urmia University of Medical Sciences

The Effect of Resistant Starch Supplementation on Antioxidant Status and Insulin Resistance in Overweight and Obese Adults

The aim of this study is to evaluate whether supplementation with resistant starch improves biomarkers associated with antioxidant status and insulin resistance in subjects with overweight and obesity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Overweight and obese adults
  • Age: 20-50 years

Exclusion Criteria:

  • weight loss or gain (more than10%) over the past 6 months, or weight loss (more than 5%) over the past 1 month
  • pregnancy, lactation or menopause
  • History of acute disease or clinical evidence of cancer, acute or chronic inflammatory diseases, cardiovascular disease, renal disease, liver disease, thyroid or endocrine disease
  • Gastrointestinal disease of which ingredients found in the study products have adverse effects on that
  • Use of antihypertensive, lipid lowering or glucose lowering medications
  • Taking antioxidant, vitamin, and/or mineral supplements
  • smoking

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: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Hi-maize resistant starch
13.5 g/day
Dietary supplement: Hi-maize resistant starch
13.5 g/day
PLACEBO_COMPARATOR: Maltodextrin
13.5 g/day
Dietary supplement: Maltodextrin
13.5 g/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antioxidant status
Time Frame: 4 weeks
Superoxide dismutase (SOD), Plasma malondialdehyde (MDA), Total antioxidant capacity (TAC)
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: 4 weeks
4 weeks
Insulin resistance
Time Frame: 4 weeks
Fasting glucose, Fasting insulin, Insulin resistant (HOMA-IR)
4 weeks
Lipid profile
Time Frame: 4 weeks
Triglyceride, Total cholesterol, HDL-cholesterol, LDL-cholesterol, Total cholesterol/HDL-cholesterol
4 weeks
Anthropometric parameters
Time Frame: 4 weeks
Height, Weight, Body Mass Index (BMI), Waist circumference
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Urmia University of Medical Sciences

Investigators

  • Principal Investigator: Mohammad Alizadeh, PhD, Assistant Professor in Nutrition

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

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

August 1, 2013

Primary Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

November 5, 2013

First Submitted That Met QC Criteria

November 19, 2013

First Posted (ESTIMATE)

November 25, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

August 18, 2015

Last Update Submitted That Met QC Criteria

August 14, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • umsu.rec.1392.75

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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