Modulation of Insulin Sensitivity by Betaine Upregulation of FGF21

Insulin Sensitivity Clinical Trial

Official title:

Modulation of Insulin Sensitivity by Betaine Upregulation of FGF21

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02118142
• Other study ID #: 13-2548
• Status: Completed
• Phase: N/A
• First received: April 2, 2014
• Last updated: August 11, 2014
• Start date: March 2014
• Est. completion date: July 2014

Study information

• Verified date: August 2014
• Source: UNC Nutrition Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Insulin Resistance
• Insulin Sensitivity

Intervention

Dietary Supplement:
• Betaine
6 gram one-time dose of betaine delivered in encapsulated form with an unsweetened beverage
• Dextrose
6 gram one-time dose of dextrose delivered in encapsulated form with an unsweetened beverage

Locations

Country	Name	City	State
United States	UNC Nutrition Research Institute	Kannapolis	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UNC Nutrition Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Fetal Growth Factor 21 (FGF21) concentration		0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement	No
Primary	Plasma choline concentration		0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement	No
Primary	Plasma betaine concentration		0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement	No
Primary	Plasma glucose concentration		0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement	No
Primary	Plasma insulin concentration		0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement	No
Primary	Plasma adiponectin concentration		0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement	No
Secondary	Typical dietary intake	Assessed via questionnaire	During day 2 of the first 3 day phase	No
Secondary	Typical exercise habits	Assessed via questionnaire	During day 2 of the first 3 day phase	No