Role of Slowly Digesible Starch on Diabetes Risk Factors

Prediabetes Clinical Trial

— STARCH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01708694
• Other study ID #: PBRC 12009
• Secondary ID: R01DK092575
• Status: Completed
• Phase: N/A
• First received: October 10, 2012
• Last updated: December 13, 2017
• Start date: August 2012
• Est. completion date: June 2016

Study information

• Verified date: December 2017
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prediabetes
• Prediabetic State

Intervention

Dietary Supplement:
• Amylose
One group of participants will consume a yogurt containing 45 g of amylose (the slowly digesting starch) for 3 months.
• Amylopectin
The second group will consume a yogurt containing 45 g of a different starch called amylopectin (the "placebo") for 3 months.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin Sensitivity and Secretion	Insulin sensitivity and secretion will be assessed via a Frequently Sampled Intravenous Glucose Tolerance Test (FSIGTT).	3 months
Secondary	Body Composition	DXA and MRS will be performed to measure body composition (adipose, muscle, bone mineral content) and to measure hepatic and intramyocellular lipids, respectively.	3 months
Secondary	Gut Microbiota	Stool samples will be collected and fecal bacteria diversity will be measured in conjunction with metagenomic analysis.	3 months
Secondary	Satiety	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.	3 months
Secondary	Hunger	Hunger will be measured through visual analogue scales (VAS), remote food photography, and a food intake test.	3 months