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Resistant Starch, Antioxidant Status and Insulin Resistance

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Hi-maize resistant starch
Maltodextrin
Sponsored by
Urmia University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Overweight focused on measuring Resistant Starch, Antioxidant Status, Insulin Resistance, Overweight, Obesity

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Hi-maize resistant starch

Maltodextrin

Arm Description

13.5 g/day

13.5 g/day

Outcomes

Primary Outcome Measures

Antioxidant status
Superoxide dismutase (SOD), Plasma malondialdehyde (MDA), Total antioxidant capacity (TAC)

Secondary Outcome Measures

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

Full Information

First Posted
November 5, 2013
Last Updated
August 14, 2015
Sponsor
Urmia University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01992783
Brief Title
Resistant Starch, Antioxidant Status and Insulin Resistance
Official Title
The Effect of Resistant Starch Supplementation on Antioxidant Status and Insulin Resistance in Overweight and Obese Adults
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Urmia University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Resistant Starch, Antioxidant Status, Insulin Resistance, Overweight, Obesity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hi-maize resistant starch
Arm Type
Experimental
Arm Description
13.5 g/day
Arm Title
Maltodextrin
Arm Type
Placebo Comparator
Arm Description
13.5 g/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Hi-maize resistant starch
Intervention Description
13.5 g/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Intervention Description
13.5 g/day
Primary Outcome Measure Information:
Title
Antioxidant status
Description
Superoxide dismutase (SOD), Plasma malondialdehyde (MDA), Total antioxidant capacity (TAC)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Insulin resistance
Description
Fasting glucose, Fasting insulin, Insulin resistant (HOMA-IR)
Time Frame
4 weeks
Title
Lipid profile
Description
Triglyceride, Total cholesterol, HDL-cholesterol, LDL-cholesterol, Total cholesterol/HDL-cholesterol
Time Frame
4 weeks
Title
Blood pressure
Time Frame
4 weeks
Title
Anthropometric parameters
Description
Height, Weight, Body Mass Index (BMI), Waist circumference
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad Alizadeh, PhD
Organizational Affiliation
Assistant Professor in Nutrition
Official's Role
Principal Investigator
Facility Information:
City
Urmia
State/Province
Azerbaijan-gharbi
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
31720257
Citation
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.
Results Reference
derived

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Resistant Starch, Antioxidant Status and Insulin Resistance

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