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Completed

NCT Number: NCT01992783

Resistant Starch, Antioxidant Status and Insulin Resistance

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.

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Key information

Conditions

Overweight Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Urmia, Azerbaijan-gharbi, Iran

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hi-maize resistant starch

Dietary Supplement

13.5 g/day

Maltodextrin

Dietary Supplement

13.5 g/day

Primary outcomes

  1. Antioxidant status

    Time frame: 4 weeks

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

Secondary outcomes

  1. Insulin resistance

    Time frame: 4 weeks

    Fasting glucose, Fasting insulin, Insulin resistant (HOMA-IR)

  2. Lipid profile

    Time frame: 4 weeks

    Triglyceride, Total cholesterol, HDL-cholesterol, LDL-cholesterol, Total cholesterol/HDL-cholesterol

  3. Blood pressure

    Time frame: 4 weeks

  4. Anthropometric parameters

    Time frame: 4 weeks

    Height, Weight, Body Mass Index (BMI), Waist circumference

Sponsors and collaborators

Lead sponsor

Urmia University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
First posted
Nov 25, 2013
Registry last updated
Aug 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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