Resistant Starch, Antioxidant Status and Insulin Resistance

NCT ID: NCT01992783

Last Updated: 2015-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Hi-maize resistant starch

13.5 g/day

Group Type EXPERIMENTAL

Hi-maize resistant starch

Intervention Type DIETARY_SUPPLEMENT

13.5 g/day

Maltodextrin

13.5 g/day

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

13.5 g/day

Interventions

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Hi-maize resistant starch

13.5 g/day

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin

13.5 g/day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Urmia University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohammad Alizadeh, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor in Nutrition

Locations

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Urmia, Azerbaijan-gharbi, Iran

Site Status

Countries

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Iran

References

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Eshghi F, Bakhshimoghaddam F, Rasmi Y, Alizadeh M. Effects of Resistant Starch Supplementation on Glucose Metabolism, Lipid Profile, Lipid Peroxidation Marker, and Oxidative Stress in Overweight and Obese Adults: Randomized, Double-Blind, Crossover Trial. Clin Nutr Res. 2019 Oct 28;8(4):318-328. doi: 10.7762/cnr.2019.8.4.318. eCollection 2019 Oct.

Reference Type DERIVED
PMID: 31720257 (View on PubMed)

Other Identifiers

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umsu.rec.1392.75

Identifier Type: -

Identifier Source: org_study_id

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