Role of Slowly Digesible Starch on Diabetes Risk Factors

NCT01708694 | Completed

• 2 other identifiers: PBRC 12009R01DK092575
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prediabetes

Outcome Measures

Primary Outcomes (1)

• Insulin Sensitivity and Secretion

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

  3 months

Secondary Outcomes (4)

• Body Composition

  3 months

• Gut Microbiota

  3 months

• Satiety

  3 months

• Hunger

  3 months

Study Arms (2)

Placebo Starch

PLACEBO COMPARATOR

Yogurt with about 45 g/day of placebo starch (amylopectin).

Dietary Supplement: Amylose

Experimental Starch

EXPERIMENTAL

Yogurt with about 45 g/day of slowly digestible starch (amylose).

Dietary Supplement: Amylopectin

Interventions

Amylose DIETARY_SUPPLEMENT

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

Placebo Starch

Amylopectin DIETARY_SUPPLEMENT

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

Experimental Starch

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (3)

• 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.

  PMID: 32280055 DERIVED

• 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.

  PMID: 30010698 DERIVED

• 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.

  PMID: 29274892 DERIVED

MeSH Terms

Conditions

Prediabetic State

Interventions

Amylose; Amylopectin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Starch; Dietary Carbohydrates; Carbohydrates; Glucans; Polysaccharides

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 10, 2012
• First Posted: October 17, 2012
• Study Start: August 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: December 15, 2017

Record last verified: 2017-12

Locations

US (1)