NCT06758856

Effect of Betaine and Choline on Metabolic Health

ABC (Additional Betaine and Choline) Study: Effect of Betaine and Choline Intake on Biomarkers of Metabolic Health in Humans

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: University of Guelph · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this research is to determine whether extra betaine and choline influence metabolic health in adults with overweight and obesity.

Detailed description

Betaine (N,N,N-trimethylglycine or also glycine betaine) is a derivative of choline that functions as an organic osmolyte and participates in one-carbon metabolism as a methyl donor. Betaine is naturally found in beets, wheat and spinach and sold as a food supplement without prescription. Choline is recognized as an essential nutrient that is found in various foods including eggs, nuts and beef, with the major form of choline in food found as phosphatidylcholine. In addition to being oxidized to the methyl donor betaine, choline is a precursor of several compounds involved in neurotransmitter synthesis, lipid metabolism and transport as well as the structural integrity and signaling of cell membranes. Previous studies have reported alterations in one-carbon metabolites in response to a single meal containing different forms of choline, with interindividual variability dependent on genetics and gut microbiota composition. This study will extend to longer-term impact of different forms of choline (betaine as oxidized choline and choline provided from food) with a focus on overweight and obesity, which comprise a predominant portion of the population in North America. The objective of this study is to determine the effect of betaine supplementation with or without food-form choline (eggs) on metabolic health in adults with overweight and obesity. A randomized crossover study design will be employed, which men and women of age 18-70 years with BMI 25-35 kg/m2 will participate in a 14-week study consisting of three 4-week dietary periods: 1) daily consumption of 3 grams of betaine supplement with no eggs; 2) daily consumption of 3 grams of betaine supplement with 3 whole eggs; and 3) daily consumption of 3 grams of cellulose supplement with no eggs, in a random order, each dietary period separated by a 1-week washout break. Blood, urine and fecal samples as well as anthropometric measurements will be collected at baseline, then at weeks 4, 9 and 14. The collected biological samples will be used to measure glucose and lipid markers, one-carbon metabolites and profiling of gut microbiota and genotype to determine interindividual differences in metabolism.

Conditions

• Obesity and Obesity-related Medical Conditions

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Trimethylglycine	Betaine anhydrous from sugar beets
OTHER	Eggs	3 whole eggs
DIETARY_SUPPLEMENT	Cellulose	Cellulose

Timeline

• Start date: 2025-01-31
• Primary completion: 2026-01-01
• Completion: 2026-12-01
• First posted: 2025-01-06
• Last updated: 2025-02-14

Locations

1 site across 1 country: Canada