Resistant Starch, Antioxidant Status and Insulin Resistance

Not Applicable

Completed

• Conditions: Obesity; Overweight
• Interventions: Dietary Supplement: Hi-maize resistant starch; Dietary Supplement: Maltodextrin

• Registration Number: NCT01992783
• Lead Sponsor: Urmia University of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Primary Completion: 2013-11
• Study First Submitted: 2013-11-05
• Study First Submitted QC: 2013-11-19
• Study First Posted: 2013-11-25
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-14
• Last Update Posted: 2015-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hi-maize resistant starch	Hi-maize resistant starch	13.5 g/day
Maltodextrin	Maltodextrin	13.5 g/day

Primary Outcome Measures

Name	Time	Method
Antioxidant status	4 weeks	Superoxide dismutase (SOD), Plasma malondialdehyde (MDA), Total antioxidant capacity (TAC)

Secondary Outcome Measures

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