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

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

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.

Study Overview

• Status: Completed
• Conditions: Prediabetes
• Intervention / Treatment: Dietary supplement: Amylose; Dietary supplement: Amylopectin

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.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin Sensitivity and Secretion	Insulin sensitivity and secretion will be assessed via a Frequently Sampled Intravenous Glucose Tolerance Test (FSIGTT).	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Gut Microbiota	Stool samples will be collected and fecal bacteria diversity will be measured in conjunction with metagenomic analysis.	3 months
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
Hunger	Hunger will be measured through visual analogue scales (VAS), remote food photography, and a food intake test.	3 months

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publications and helpful links

General Publications

• White U, Peterson CM, Beyl RA, Martin CK, Ravussin E. Resistant Starch Has No Effect on Appetite and Food Intake in Individuals with Prediabetes. J Acad Nutr Diet. 2020 Jun;120(6):1034-1041. doi: 10.1016/j.jand.2020.01.017. Epub 2020 Apr 9.
• Peterson CM, Beyl RA, Marlatt KL, Martin CK, Aryana KJ, Marco ML, Martin RJ, Keenan MJ, Ravussin E. Effect of 12 wk of resistant starch supplementation on cardiometabolic risk factors in adults with prediabetes: a randomized controlled trial. Am J Clin Nutr. 2018 Sep 1;108(3):492-501. doi: 10.1093/ajcn/nqy121.
• Marlatt KL, White UA, Beyl RA, Peterson CM, Martin CK, Marco ML, Keenan MJ, Martin RJ, Aryana KJ, Ravussin E. Role of resistant starch on diabetes risk factors in people with prediabetes: Design, conduct, and baseline results of the STARCH trial. Contemp Clin Trials. 2018 Feb;65:99-108. doi: 10.1016/j.cct.2017.12.005. Epub 2017 Dec 21.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: October 10, 2012
• First Submitted That Met QC Criteria: October 16, 2012
• First Posted (Estimate): October 17, 2012

Study Record Updates

• Last Update Posted (Actual): December 15, 2017
• Last Update Submitted That Met QC Criteria: December 13, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: PBRC 12009; R01DK092575 (U.S. NIH Grant/Contract)