Modulation of Insulin Sensitivity by Betaine Upregulation of FGF21

UNC Nutrition Research Institute

Status

Completed

Conditions

Insulin Sensitivity

Treatments

Dietary Supplement: Betaine

Dietary Supplement: Dextrose

Study type

Interventional

Funder types

Other

Identifiers

NCT02118142

13-2548

Details and patient eligibility

About

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.

Full 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.

Enrollment

23 patients

Sex

All

Ages

21 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy
Able/willing to consume study meals
Non-smoker
BMI in normal range (18-24.9)

Exclusion criteria

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