Metabolic Effects of Betaine Supplementation
Betaine is important in cellular metabolic pathways. Few epidemiologic studies link betaine levels to diabetes and cardiovascular disease. Small human studies suggest benefit for non-alcoholic liver disease. In this study we will determine if administration of betaine improves metabolic measures, liver fat and/or endothelial function in humans with glucose intolerance who are overweight.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
|Official Title:||Bedside to Bench and Back: Cardiometabolic Effects of Betaine Supplementation|
- Glucose tolerance [ Time Frame: 3 months ] [ Designated as safety issue: No ]Glucose tolerance test
- Hepatic fat [ Time Frame: 3 months ] [ Designated as safety issue: No ]Magnetic resonance imaging
- Endothelial Function [ Time Frame: 3 months ] [ Designated as safety issue: No ]Brachial artery reactivity
- Insulin sensitivity [ Time Frame: 3 months ] [ Designated as safety issue: No ]Euglycemic hyperinsulinemic clamp
|Study Start Date:||January 2014|
|Estimated Primary Completion Date:||October 2017 (Final data collection date for primary outcome measure)|
|Active Comparator: Betaine||
Betaine or placebo administered orally in divided doses over 3 months.
Other Name: trimethyl glycine
|Placebo Comparator: Placebo||
Placebo administered orally in divided doses over 3 months
This study is a single site, prospective, randomized (1:1), double masked, placebo controlled trial to assess metabolic effects of betaine compared to placebo on glycemia and insulin sensitivity, liver fat and endothelial function.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01950039
|Contact: Allison B. Goldfine, MDfirstname.lastname@example.org|
|United States, Massachusetts|
|Joslin Diabetes Center and Brigham and Womens Hospital||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Allison B. Goldfine, MD 617-309-2643 email@example.com|