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Modulation of Insulin Sensitivity by Betaine Upregulation of FGF21

Primary Purpose

Insulin Sensitivity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Betaine

Dextrose

About this trial

This is an interventional basic science trial for Insulin Sensitivity

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

UNC Nutrition Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Betaine

Dextrose

Arm Description

6 gram dose of betaine delivered in encapsulated form

6 gram dose of dextrose delivered in encapsulated form

Outcomes

Primary Outcome Measures

Plasma Fetal Growth Factor 21 (FGF21) concentration

Plasma choline concentration

Plasma betaine concentration

Plasma glucose concentration

Plasma insulin concentration

Plasma adiponectin concentration

Secondary Outcome Measures

Typical dietary intake

Assessed via questionnaire

Typical exercise habits

Assessed via questionnaire

Full Information

NCT ID

NCT02118142

First Posted

April 2, 2014

Last Updated

August 11, 2014

Sponsor

UNC Nutrition Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT02118142

Brief Title

Modulation of Insulin Sensitivity by Betaine Upregulation of FGF21

Official Title

Modulation of Insulin Sensitivity by Betaine Upregulation of FGF21

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Completed

Study Start Date

March 2014 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UNC Nutrition Research Institute

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insulin Sensitivity

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Betaine

Arm Type

Active Comparator

Arm Description

6 gram dose of betaine delivered in encapsulated form

Arm Title

Dextrose

Arm Type

Placebo Comparator

Arm Description

6 gram dose of dextrose delivered in encapsulated form

Intervention Type

Dietary Supplement

Intervention Name(s)

Betaine

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Dextrose

Intervention Description

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

Primary Outcome Measure Information:

Title

Plasma Fetal Growth Factor 21 (FGF21) concentration

Time Frame