Skip to main content
OpenTrials
Completed

NCT Number: NCT01708694

Role of Slowly Digesible Starch on Diabetes Risk Factors

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Amylose

Dietary Supplement

One group of participants will consume a yogurt containing 45 g of amylose (the slowly digesting starch) for 3 months.

Amylopectin

Dietary Supplement

The second group will consume a yogurt containing 45 g of a different starch called amylopectin (the "placebo") for 3 months.

Primary outcomes

  1. Insulin Sensitivity and Secretion

    Time frame: 3 months

    Insulin sensitivity and secretion will be assessed via a Frequently Sampled Intravenous Glucose Tolerance Test (FSIGTT).

Secondary outcomes

  1. Body Composition

    Time frame: 3 months

    DXA and MRS will be performed to measure body composition (adipose, muscle, bone mineral content) and to measure hepatic and intramyocellular lipids, respectively.

  2. Gut Microbiota

    Time frame: 3 months

    Stool samples will be collected and fecal bacteria diversity will be measured in conjunction with metagenomic analysis.

  3. Satiety

    Time frame: 3 months

    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.

  4. Hunger

    Time frame: 3 months

    Hunger will be measured through visual analogue scales (VAS), remote food photography, and a food intake test.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Role of Slowly Digesible Starch on Diabetes Risk Factors In Pre-diabetic People

Acronym: STARCH

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Oct 17, 2012
Registry last updated
Dec 15, 2017

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.

Published trials that share one or more normalized conditions with this study.