Modulation of Insulin Sensitivity by Betaine Upregulation of FGF21

NCT02118142 | Completed

• 1 other identifier: 13-2548
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Sensitivity

Outcome Measures

Primary Outcomes (6)

• 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 (2)

• Typical dietary intake

  During day 2 of the first 3 day phase

• Typical exercise habits

  During day 2 of the first 3 day phase

Study Arms (2)

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

Betaine DIETARY_SUPPLEMENT

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

Betaine

Dextrose DIETARY_SUPPLEMENT

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

Dextrose

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy
• Able/willing to consume study meals
• Non-smoker
• BMI in normal range (18-24.9)

You may not qualify if:

• 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

Sponsors & Collaborators

• UNC Nutrition Research Institute: lead

Study Sites (1)

UNC Nutrition Research Institute

Kannapolis, North Carolina, 28081, United States

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

Betaine; Glucose

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Karen Corbin, PhD, RD

  UNC Nutrition Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2014
• First Posted: April 21, 2014
• Study Start: March 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 12, 2014

Record last verified: 2014-08

Locations

US (1)