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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 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: August 8, 2014
Last verified: August 2014
  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
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, see Learn About Clinical Studies.

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: August 8, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 21, 2014