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Resistant Starch, Antioxidant Status and Insulin Resistance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01992783
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : August 18, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Overweight Obesity Dietary Supplement: Hi-maize resistant starch Dietary Supplement: Maltodextrin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: The Effect of Resistant Starch Supplementation on Antioxidant Status and Insulin Resistance in Overweight and Obese Adults
Study Start Date : August 2013
Actual Primary Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants
Drug Information available for: Starch

Arm Intervention/treatment
Experimental: Hi-maize resistant starch
13.5 g/day
Dietary Supplement: Hi-maize resistant starch
13.5 g/day

Placebo Comparator: Maltodextrin
13.5 g/day
Dietary Supplement: Maltodextrin
13.5 g/day




Primary Outcome Measures :
  1. Antioxidant status [ Time Frame: 4 weeks ]
    Superoxide dismutase (SOD), Plasma malondialdehyde (MDA), Total antioxidant capacity (TAC)


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992783


Locations
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Iran, Islamic Republic of
Urmia, Azerbaijan-gharbi, Iran, Islamic Republic of
Sponsors and Collaborators
Urmia University of Medical Sciences
Investigators
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Principal Investigator: Mohammad Alizadeh, PhD Assistant Professor in Nutrition
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Urmia University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01992783    
Other Study ID Numbers: umsu.rec.1392.75
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: August 18, 2015
Last Verified: August 2015
Keywords provided by Urmia University of Medical Sciences:
Resistant Starch
Antioxidant Status
Insulin Resistance
Overweight
Obesity
Additional relevant MeSH terms:
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Insulin Resistance
Overweight
Body Weight
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases