Role of Slowly Digesible Starch on Diabetes Risk Factors(STARCH)

This study is currently recruiting participants.
Verified December 2013 by Pennington Biomedical Research Center
Sponsor:
Information provided by (Responsible Party):
Eric Ravussin, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01708694
First received: October 10, 2012
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to determine the effect of a slowly digesting starch on gut bacteria, sugar and fat metabolism, hunger hormones, and body fat in people with pre-diabetes.


Condition Intervention
Prediabetes
Dietary Supplement: Amylose
Dietary Supplement: Amylopectin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Role of Slowly Digesible Starch on Diabetes Risk Factors(STARCH)

Resource links provided by NLM:


Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Insulin Sensitivity and Secretion [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Insulin sensitivity and secretion will be assessed via a Frequently Sampled Intravenous Glucose Tolerance Test (FSIGTT).


Secondary Outcome Measures:
  • Body Composition [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    DXA and MRS will be performed to measure body composition (adipose, muscle, bone mineral content) and to measure hepatic and intramyocellular lipids, respectively.

  • Gut Microbiota [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Stool samples will be collected and fecal bacteria diversity will be measured in conjunction with metagenomic analysis.

  • Satiety [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Satiety hormones will be measured following ingestion of a standardized smoothie (Standard Meal Test). Satiety will be measured through visual analogue scales (VAS), remote food photography, and a food intake test.

  • Hunger [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Hunger will be measured through visual analogue scales (VAS), remote food photography, and a food intake test.


Estimated Enrollment: 95
Study Start Date: August 2012
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Starch
Yogurt with about 45 g/day of placebo starch (amylopectin).
Dietary Supplement: Amylose
One group of participants will consume a yogurt containing 45 g of amylose (the slowly digesting starch) for 3 months.
Experimental: Experimental Starch
Yogurt with about 45 g/day of slowly digestible starch (amylose).
Dietary Supplement: Amylopectin
The second group will consume a yogurt containing 45 g of a different starch called amylopectin (the "placebo") for 3 months.

Detailed Description:

In a double blind randomized controlled clinical trial, the investigators will test the effect of slowly digesting starch (amylose) versus a placebo starch (amylopectin) on risk factors for type 2 diabetes. For the study, about 95 obese participants (ages 35-65) with pre-diabetes (impaired fasting glucose) will consume a yogurt containing about 45 g of either the experimental or placebo starch daily for 3 months. The investigators will test the hypothesis that, compared to controls, a daily intake of 45 g of amylose for 3 months will improve risk factors for the development of type 2 diabetes (insulin sensitivity and secretion) by decreasing ectopic fat depots and decreasing inflammation in parallel with a change in colonic microbial populations.

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Have a body mass index between 30 and 44.9 kg/m2
  • Are 35-65 years of age
  • Have pre-diabetes, which means impaired fasting glucose (IFG)
  • Are willing to complete nutritional and activity questionnaires and 2-3 weeks of baseline testing
  • Are willing to enroll in the 3-month intervention and maintain the same level of exercise during the study
  • Are willing to maintain weight throughout the study

Exclusion Criteria

  • Have evidence of cardiovascular disease, diabetes, symptomatic cholelithiasis (gallstones), or cancer
  • Have a fasting blood glucose less than 100 mg/dL or greater than 125 mg/dL
  • Have an average screening blood pressure > 150/100 mm Hg
  • Are a pre-menopausal woman but do not have a regular menstrual cycle
  • Are pregnant or breastfeeding
  • Chronically use medications including diuretics, steroids, and adrenergic-stimulating agents
  • Have emotional problems such as clinical depression or other diagnosed psychological conditions
  • Use hormonal contraceptives, oral or parenteral glucocorticoids, or any other medication known to influence glucose or insulin homeostasis (balance), within 1 month of study
  • Have a clinically significant gastrointestinal malabsorption syndrome, chronic diarrhea, or use antibiotics within one month of study
  • Have abnormal laboratory markers (e.g., elevated potassium levels, hemoglobin or hematocrit below the lower limit of normal)
  • Chronically consume alcohol (> 4 servings per day) or actively smoke cigarettes (> 1/4 pack per day)
  • Are on any chronic medication that has not had a stable dose for 1 month or longer
  • Are required to perform of any kind of heavy physical activity
  • Have metal objects in the body, such as a pacemaker, metal pins, bullet, etc.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01708694

Locations
United States, Louisiana
Pennington Biomedical Research Center Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: recruiting    225-763-3000    recruiters@pbrc.edu   
Principal Investigator: Eric Ravussin, PhD         
Sub-Investigator: Frank Greenway, MD         
Sub-Investigator: Corby K. Martin, PhD         
Sub-Investigator: Courtney M. Peterson, PhD         
Sub-Investigator: Roy Martin, PhD         
Sub-Investigator: Mike Keenan, PhD         
Sub-Investigator: Kayanush Aryana, PhD         
Sub-Investigator: Maria Marco, PhD         
Sponsors and Collaborators
Pennington Biomedical Research Center
  More Information

No publications provided

Responsible Party: Eric Ravussin, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01708694     History of Changes
Other Study ID Numbers: PBRC12009
Study First Received: October 10, 2012
Last Updated: December 3, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Glucose Intolerance
Prediabetic State
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014