An interventional study of Betaine and Dextrose in Insulin Sensitivity, sponsored by UNC Nutrition Research Institute. Completed at 1 site in United States. Open to participants aged 21 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-08-12.
Sponsored by UNC Nutrition Research Institute · Not applicable, Interventional, and Basic science
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.
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.
1,959 studies on the registry are indexed under Insulin Resistance; 305 are open to participants now.
This study's enrollment of 23 is below the median of 40 across 1,535 interventional studies indexed under Insulin Resistance.
Browse Insulin Resistance studies →UNC Nutrition Research Institute is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
6 gram dose of betaine delivered in encapsulated form
Dietary Supplement: Betaine
6 gram dose of dextrose delivered in encapsulated form
Dietary Supplement: Dextrose
6 gram one-time dose of betaine delivered in encapsulated form with an unsweetened beverage
6 gram one-time dose of dextrose delivered in encapsulated form with an unsweetened beverage
Plasma Fetal Growth Factor 21 (FGF21) concentration
Time frame: 0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement
Plasma choline concentration
Time frame: 0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement
Plasma betaine concentration
Time frame: 0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement
Plasma glucose concentration
Time frame: 0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement
Plasma insulin concentration
Time frame: 0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement
Plasma adiponectin concentration
Time frame: 0, 0.5, 1, 2, 4, 8, and 24 hours post- betaine or placebo supplement
Typical dietary intake
Assessed via questionnaire
Time frame: During day 2 of the first 3 day phase
Typical exercise habits
Assessed via questionnaire
Time frame: During day 2 of the first 3 day phase
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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UNC Nutrition Research Institute