34 Participants Needed

Betaine and Choline for Obesity

CE
AM
Overseen ByAlison M. Duncan, RD, PhD

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does exclude participants using hormone therapy, antibiotics, prebiotics, probiotics, or dietary fiber supplements.

Is betaine and choline safe for humans?

Research on choline and betaine in humans is limited, but studies suggest they are generally safe. Choline is involved in fat metabolism and has been studied for its effects on cholesterol and body composition, with no major safety concerns reported.12345

How does the treatment with betaine and choline for obesity differ from other treatments?

Betaine and choline are unique in treating obesity because they help improve lipid metabolism and body composition by participating in mitochondrial processes that enhance fat breakdown and energy use. Unlike many traditional obesity treatments, which may focus on appetite suppression or calorie restriction, this approach targets metabolic pathways to reduce body fat and improve muscle mass.25678

What is the purpose of this trial?

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

Eligibility Criteria

Adults aged 18-70 with a BMI of 25-35 kg/m2, non-smokers, willing to fast before lab visits and consume eggs as part of the study. Excluded are those using recreational drugs or certain supplements, with allergies to eggs, pregnant/breastfeeding women, vegans, smokers, or those with chronic illnesses.

Inclusion Criteria

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
BMI between 25-35 kg/m2
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Exclusion Criteria

I do not use recreational drugs.
Use of prebiotics, probiotics or dietary fiber (i.e., Metamucil) supplements in the last 2 months
BMI < 25 kg/m2 or BMI > 35 kg/m2
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo three 4-week dietary periods with different supplement and food combinations, each separated by a 1-week washout break

14 weeks
Visits at weeks 0, 4, 9, and 14 for sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Betaine
  • Choline
Trial Overview The trial is testing if adding betaine (found in beets) and choline (in eggs) can improve metabolic health in overweight adults. Participants will eat three eggs daily for four weeks and avoid them otherwise during the study.
Participant Groups
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental: No eggs with daily supplement containing 3 g trimethylglycineExperimental Treatment1 Intervention
Group II: Daily 3 whole eggs with daily supplement containing 3 g trimethylglycineExperimental Treatment2 Interventions
Group III: Placebo Comparator: No eggs with daily supplement containing 3 g cellulosePlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Guelph

Lead Sponsor

Trials
87
Recruited
15,100+

Findings from Research

In a study of 12 obese cats over 5 weeks, dietary choline supplementation did not change body weight or composition but significantly altered serum lipid profiles, indicating potential metabolic effects.
Choline may help reduce hepatic fat by enhancing fat mobilization and improving methionine recycling, which could be beneficial for managing obesity-related liver issues in cats.
Serum Lipid, Amino Acid and Acylcarnitine Profiles of Obese Cats Supplemented with Dietary Choline and Fed to Maintenance Energy Requirements.Verbrugghe, A., Rankovic, A., Armstrong, S., et al.[2021]
In a study of 1081 participants, higher serum levels of choline and betaine were linked to lower body fat and better body composition in males, particularly in those not taking medications.
The research found that obese males had the lowest levels of choline and betaine, suggesting that these compounds may play a role in managing body weight and composition.
Higher serum choline and betaine levels are associated with better body composition in male but not female population.Gao, X., Randell, E., Zhou, H., et al.[2018]
Maternal betaine supplementation in obese mice prevented fetal and placental overgrowth and downregulated key transporters and growth factors at an early stage of pregnancy (E12.5), but these effects diminished by later stages (E17.5).
At E17.5, betaine supplementation reduced fetal fat accumulation and liver triglyceride levels, while enhancing the expression of a gene that supports fat metabolism, indicating that betaine may have a unique role in managing fetal metabolic health compared to choline.
Maternal betaine supplementation affects fetal growth and lipid metabolism of high-fat fed mice in a temporal-specific manner.Joselit, Y., Nanobashvili, K., Jack-Roberts, C., et al.[2019]

References

Serum Lipid, Amino Acid and Acylcarnitine Profiles of Obese Cats Supplemented with Dietary Choline and Fed to Maintenance Energy Requirements. [2021]
Higher serum choline and betaine levels are associated with better body composition in male but not female population. [2018]
Maternal betaine supplementation affects fetal growth and lipid metabolism of high-fat fed mice in a temporal-specific manner. [2019]
Dietary choline increases brown adipose tissue activation markers and improves cholesterol metabolism in female APOE*3-Leiden.CETP mice. [2023]
Dietary choline and betaine intake, cardio-metabolic risk factors and prevalence of metabolic syndrome among overweight and obese adults. [2023]
Betaine and Choline Improve Lipid Homeostasis in Obesity by Participation in Mitochondrial Oxidative Demethylation. [2020]
Association between serum choline and betaine concentrations and longitudinal changes of body composition in community-dwelling middle-aged and older Chinese adults. [2021]
Higher Dietary Choline and Betaine Intakes Are Associated with Better Body Composition in the Adult Population of Newfoundland, Canada. [2019]
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