Resistant Starch, Antioxidant Status and Insulin Resistance

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01992783
• Other study ID #: umsu.rec.1392.75
• Status: Completed
• Phase: N/A
• First received: November 5, 2013
• Last updated: August 14, 2015
• Start date: August 2013

Study information

• Verified date: August 2015
• Source: Urmia University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity
• Overweight

Intervention

Dietary Supplement:
• Hi-maize resistant starch
13.5 g/day
• Maltodextrin
13.5 g/day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Urmia University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antioxidant status	Superoxide dismutase (SOD), Plasma malondialdehyde (MDA), Total antioxidant capacity (TAC)	4 weeks	No
Secondary	Insulin resistance	Fasting glucose, Fasting insulin, Insulin resistant (HOMA-IR)	4 weeks	No
Secondary	Lipid profile	Triglyceride, Total cholesterol, HDL-cholesterol, LDL-cholesterol, Total cholesterol/HDL-cholesterol	4 weeks	No
Secondary	Blood pressure		4 weeks	No
Secondary	Anthropometric parameters	Height, Weight, Body Mass Index (BMI), Waist circumference	4 weeks	No