Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
NCT Number: NCT01708694
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.
Looking for future studies?
Notify Me35 year–65 year
All sexes
Interventional
Not applicable
Baton Rouge, Louisiana, 70808, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
One group of participants will consume a yogurt containing 45 g of amylose (the slowly digesting starch) for 3 months.
The second group will consume a yogurt containing 45 g of a different starch called amylopectin (the "placebo") for 3 months.
Time frame: 3 months
Insulin sensitivity and secretion will be assessed via a Frequently Sampled Intravenous Glucose Tolerance Test (FSIGTT).
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.
Time frame: 3 months
Stool samples will be collected and fecal bacteria diversity will be measured in conjunction with metagenomic analysis.
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.
Time frame: 3 months
Hunger will be measured through visual analogue scales (VAS), remote food photography, and a food intake test.
Pennington Biomedical Research Center
Other
Role of Slowly Digesible Starch on Diabetes Risk Factors In Pre-diabetic People
Acronym: STARCH
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.
NCT07618663
Diabetes Mellitus, Endocrine System Diseases
Lahore, Shaikhupura, Pakistan
View Trial DetailsNCT05351359
Diabetes Mellitus, Diabetes Mellitus, Type 2
Prague, Czechia
View Trial DetailsNCT07713394
Behavior, Body Weight
Erzurum, Turkey, Turkey (Türkiye)
View Trial DetailsNCT07710898
Diabete Mellitus, Diabetes Mellitus
Lahore, Pakistan
View Trial Details