Modulation of Insulin Sensitivity by Betaine Upregulation of FGF21

NCT ID: NCT02118142

Last Updated: 2014-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-07-31

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.

Conditions

Insulin Sensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Betaine

6 gram dose of betaine delivered in encapsulated form

Group Type: ACTIVE_COMPARATOR

Betaine

Intervention Type: DIETARY_SUPPLEMENT

6 gram one-time dose of betaine delivered in encapsulated form with an unsweetened beverage

Dextrose

6 gram dose of dextrose delivered in encapsulated form

Group Type: PLACEBO_COMPARATOR

Dextrose

Intervention Type: DIETARY_SUPPLEMENT

6 gram one-time dose of dextrose delivered in encapsulated form with an unsweetened beverage

Interventions

Betaine

6 gram one-time dose of betaine delivered in encapsulated form with an unsweetened beverage

Intervention Type: DIETARY_SUPPLEMENT

Dextrose

6 gram one-time dose of dextrose delivered in encapsulated form with an unsweetened beverage

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

UNC Nutrition Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karen Corbin, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

UNC Nutrition Research Institute

Locations

UNC Nutrition Research Institute

Kannapolis, North Carolina, United States

Countries

United States

Other Identifiers

13-2548

Identifier Type: -

Identifier Source: org_study_id