Modulation of Insulin Sensitivity by Betaine Upregulation of FGF21
- Conditions
- Insulin Sensitivity
- Interventions
- Dietary Supplement: DextroseDietary Supplement: Betaine
- Registration Number
- NCT02118142
- Lead Sponsor
- UNC Nutrition Research Institute
- Brief Summary
People with poor insulin sensitivity do not respond normally to elevations in blood sugar. This may increase their risk of developing diabetes in the future. The purpose of this research study is to determine if the nutrient betaine, found in beets, spinach and wheat products, can enhance the production of fetal growth factor 21 (FGF21), a molecule that is believed to promote insulin sensitivity.
- Detailed Description
AIM: To determine if betaine is a modulator of FGF21 in humans. Low plasma betaine is associated with an increased risk of metabolic syndrome, but the mechanisms modulating this correlation are poorly delineated. Betaine bioavailability in humans is determined by dietary intake and genetic polymorphisms that influence betaine metabolism. Therefore, moderating betaine levels could be particularly beneficial for some individuals. FGF21 is elevated in response to insulin insensitivity and is under active investigation as a therapeutic modality. The mechanisms of action of FGF21 and betaine on insulin sensitivity in humans are incompletely understood. This study tests the hypothesis that betaine induces FGF21 secretion and insulin sensitizing actions in humans by measuring plasma FGF21, betaine, choline (betaine precursor), glucose, insulin and adiponectin in response to betaine supplementation over a 24 hour time course in 20 healthy, lean individuals. This pilot nutrition intervention will provide key preliminary evidence for understanding whether and how betaine exerts metabolic benefit in humans and will inform a future study to investigate the novel betaine-FGF21-insulin sensitivity axis in a larger cohort.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
- Healthy
- Able/willing to consume study meals
- Non-smoker
- BMI in normal range (18-24.9)
- Use of chronic medications
- Abnormal physical examination or chronic illness
- Use of drugs or medications known to alter choline/betaine metabolism
- Consumption of more than 2 oz of alcohol/day or 24 oz wine/day
- Use of choline/betaine-containing dietary supplements during the previous 3 months
- Diagnosed with Cystathionine Beta-Synthase (CBS) Deficiency
- Pregnant or breastfeeding
- Known hypersensitivity to betaine
- Current substance abuse or addiction
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Dextrose Dextrose 6 gram dose of dextrose delivered in encapsulated form Betaine Betaine 6 gram dose of betaine delivered in encapsulated form
- Primary Outcome Measures
Name Time Method Plasma glucose concentration 0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement Plasma Fetal Growth Factor 21 (FGF21) concentration 0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement Plasma choline concentration 0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement Plasma betaine concentration 0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement Plasma insulin concentration 0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement Plasma adiponectin concentration 0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement
- Secondary Outcome Measures
Name Time Method Typical dietary intake During day 2 of the first 3 day phase Assessed via questionnaire
Typical exercise habits During day 2 of the first 3 day phase Assessed via questionnaire
Trial Locations
- Locations (1)
UNC Nutrition Research Institute
🇺🇸Kannapolis, North Carolina, United States