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

Primary Purpose

Prediabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Amylose
Amylopectin
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Prediabetes

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pennington Biomedical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Starch

Experimental Starch

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 10, 2012
Last Updated
December 13, 2017
Sponsor
Pennington Biomedical Research Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT01708694
Brief Title
Role of Slowly Digesible Starch on Diabetes Risk Factors
Acronym
STARCH
Official Title
Role of Slowly Digesible Starch on Diabetes Risk Factors In Pre-diabetic People
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetes

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Starch
Arm Type
Placebo Comparator
Arm Description
Yogurt with about 45 g/day of placebo starch (amylopectin).
Arm Title
Experimental Starch
Arm Type
Experimental
Arm Description
Yogurt with about 45 g/day of slowly digestible starch (amylose).
Intervention Type
Dietary Supplement
Intervention Name(s)
Amylose
Intervention Description
One group of participants will consume a yogurt containing 45 g of amylose (the slowly digesting starch) for 3 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Amylopectin
Intervention Description
The second group will consume a yogurt containing 45 g of a different starch called amylopectin (the "placebo") for 3 months.
Primary Outcome Measure Information:
Title
Insulin Sensitivity and Secretion
Description
Insulin sensitivity and secretion will be assessed via a Frequently Sampled Intravenous Glucose Tolerance Test (FSIGTT).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Body Composition
Description
DXA and MRS will be performed to measure body composition (adipose, muscle, bone mineral content) and to measure hepatic and intramyocellular lipids, respectively.
Time Frame
3 months
Title
Gut Microbiota
Description
Stool samples will be collected and fecal bacteria diversity will be measured in conjunction with metagenomic analysis.
Time Frame
3 months
Title
Satiety
Description
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.
Time Frame
3 months
Title
Hunger
Description
Hunger will be measured through visual analogue scales (VAS), remote food photography, and a food intake test.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32280055
Citation
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.
Results Reference
derived
PubMed Identifier
30010698
Citation
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.
Results Reference
derived
PubMed Identifier
29274892
Citation
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.
Results Reference
derived

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Role of Slowly Digesible Starch on Diabetes Risk Factors

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