Impact of Betaine and Choline on Metabolic Health in Overweight Adults
ABC (Additional Betaine and Choline) Study: Effect of Betaine and Choline Intake on Biomarkers of Metabolic Health in Humans
This study is testing if taking betaine and choline supplements can improve metabolic health in overweight adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Guelph Academic / other |
| Locations | 1 site (Guelph, Ontario) |
| Trial ID | NCT06758856 on ClinicalTrials.gov |
What this trial studies
This research investigates the effects of betaine and choline supplementation on metabolic health in adults with overweight and obesity. The study will utilize a randomized crossover design, where participants will consume either betaine, eggs (a source of choline), or cellulose over a specified period. Participants aged 18-70 with a BMI between 25-35 kg/m2 will be recruited, and their metabolic responses will be monitored through biological specimen samples and dietary records. The goal is to assess how these nutrients influence metabolic health over time.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with a BMI between 25-35 kg/m2 who are willing to follow specific dietary protocols.
Not a fit: Patients with a BMI below 25 or above 35, as well as those who are pregnant or breastfeeding, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into dietary interventions that improve metabolic health in individuals with obesity.
How similar studies have performed: Previous studies have shown varying effects of choline on metabolism, but this specific approach of combining betaine and food-derived choline is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female participant of any race or ethnicity between 18-70 years of age (inclusive) at the time of informed consent * BMI between 25-35 kg/m2 * Non-smoker * Willing to consume 3 eggs per day for one dietary period of 4 weeks * Willing to avoid eggs during the rest of the study including washout period breaks except for eggs that are provided * Willing to fast before the baseline and dietary period lab visits * Willing to provide a 24-hr prior day food record at the dietary period lab visits * Willing to provide or collect biological specimen samples at the baseline and dietary period lab visits * Willing to follow the study protocol including maintaining usual lifestyle during the entire study Exclusion Criteria: * Male or female \< 18 years or \> 70 years of age at the time of consent * BMI \< 25 kg/m2; or BMI \> 35 kg/m2 * Pregnant or planning to become pregnant during the course of the study; currently breastfeeding or postpartum \< 6 months * Use of hormone therapy including birth control pills * Follows a vegan diet * Current smoker (any form of nicotine, e-cigarettes, etc) * Use of recreational drugs (may affect metabolic pathway for choline) * Presence of chronic illnesses, e.g., heart disease, diabetes, cancer, celiac disease, inflammatory bowel disease (Crohn's disease and ulcerative colitis), gastrointestinal liver or kidney diseases or alcoholism * Diagnosis of trimethylaminuria (genetic disorder affecting choline use in body) * Use of antibiotics in the last 2 months * Use of prebiotics, probiotics or dietary fiber (i.e., Metamucil) supplements in the last 2 months * Have allergies to eggs or any anaphylactic food allergies * Have a schedule or lifestyle patterns incompatible with the study protocol
Where this trial is running
Guelph, Ontario
- Human Nutraceutical Research Unit — Guelph, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Clara E. Cho, PhD
- Email: claracho@uoguelph.ca
- Phone: 519-824-4120
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.