Clinical trial NCT02118142: Modulation of Insulin Sensitivity by Betaine Upregulation of FGF21
Official title: Modulation of Insulin Sensitivity by Betaine Upregulation of FGF21
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Sensitivity
Lead sponsor: UNC Nutrition Research Institute
Sponsor class: OTHER
First posted: 2014-04-21
Enrollment: 23
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Plasma Fetal Growth Factor 21 (FGF21) concentration
timeFrame: 0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement
measure: Plasma choline concentration
timeFrame: 0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement
measure: Plasma betaine concentration
timeFrame: 0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement
measure: Plasma glucose concentration
timeFrame: 0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement
measure: Plasma insulin concentration
timeFrame: 0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement
measure: Plasma adiponectin concentration
timeFrame: 0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement
Secondary outcomes:
measure: Typical dietary intake
timeFrame: During day 2 of the first 3 day phase
measure: Typical exercise habits
timeFrame: During day 2 of the first 3 day phase
Other outcomes:
Locations:
city: Kannapolis
country: United States
facility: UNC Nutrition Research Institute
state: North Carolina
Study officials:
affiliation: UNC Nutrition Research Institute
name: Karen Corbin, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: