RecruitingNot ApplicableNCT06758856
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
Sponsor
University of Guelph
Enrollment
34 participants
Start Date
Jan 31, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this research is to determine whether extra betaine and choline influence metabolic health in adults with overweight and obesity.
Eligibility
Min Age: 18 YearsMax Age: 70 Years
Inclusion Criteria9
- 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 Criteria13
- 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
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Interventions
DIETARY_SUPPLEMENTTrimethylglycine
Betaine anhydrous from sugar beets
OTHEREggs
3 whole eggs
DIETARY_SUPPLEMENTCellulose
Cellulose
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06758856
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