Modulation of Insulin Sensitivity by Betaine Upregulation... | NCT02118142

Studies
Modulation of Insulin Sensitivity by Betaine Upregulation of FGF21

NCT02118142

Sponsor

UNC Nutrition Research Institute

Status

Completed

Last Update Posted

Aug 12, 2014Estimated

Enrollment

23Actual

Phase

Not Applicable

Conditions

Insulin Sensitivity

Interventions

Betaine
Dextrose

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Jul 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Apr 2, 2014

First Submission Date that Met QC Criteria

Apr 15, 2014

First Posted Date

Apr 21, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 11, 2014

Last Update Posted Date

Aug 12, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Betaine	Active Comparator	6 gram dose of betaine delivered in encapsulated form	Dietary Supplement: Betaine
Dextrose	Placebo Comparator	6 gram dose of dextrose delivered in encapsulated form	Dietary Supplement: Dextrose

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Betaine	Dietary Supplement	6 gram one-time dose of betaine delivered in encapsulated form with an unsweetened beverage	Betaine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Plasma Fetal Growth Factor 21 (FGF21) concentration		0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement
Plasma choline concentration		0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement
Plasma betaine concentration		0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement
Plasma glucose concentration		0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement
Plasma insulin concentration		0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement
Plasma adiponectin concentration		0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement

Secondary Outcomes

Measure	Description	Time Frame
Typical dietary intake	Assessed via questionnaire	During day 2 of the first 3 day phase
Typical exercise habits	Assessed via questionnaire

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karen Corbin, PhD, RD	UNC Nutrition Research Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UNC Nutrition Research Institute		Kannapolis	North Carolina	28081	United States

Condition Browse Module

MeSH Terms

ID	Term
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001622	Betaine
D005947	Glucose

Ancestor Terms

ID	Term
D050337	Trimethyl Ammonium Compounds
D000644	Quaternary Ammonium Compounds
D000588	Amines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided