34 Participants Needed

Betaine and Choline for Obesity

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Overseen ByAlison M. Duncan, RD, PhD

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether extra betaine and choline can improve metabolic health in overweight adults. Participants will join one of three groups: one group will consume three eggs daily with a supplement, another will take the supplement without eggs, and the last will receive a placebo (a substance with no active ingredients). Individuals with a BMI (a measure of body fat based on height and weight) between 25 and 35 who are willing to follow the study's egg-eating and fasting guidelines may be suitable candidates.

As an unphased trial, this study provides a unique opportunity to contribute to scientific understanding and potentially enhance metabolic health.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that betaine is generally safe for consumption. The FDA has approved its use in food and supplements. However, some studies suggest that taking 4 grams daily might raise certain cholesterol levels, such as LDL, often referred to as "bad" cholesterol. In contrast, European health authorities consider 400 milligrams per day to be safe.

Choline, an essential nutrient that supports many body functions, is naturally found in foods like eggs and meat. It is usually well-tolerated, but consuming very high amounts can lead to side effects such as sweating, a fishy body odor, or low blood pressure.

Overall, both betaine and choline have been well-studied and approved for use. Following the recommended doses is important to avoid potential issues.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatments using betaine and choline for obesity because they offer a fresh approach by leveraging natural compounds. Unlike traditional treatments that often focus on appetite suppression or increasing metabolism through medication, these treatments aim to improve fat metabolism and liver function, potentially offering a more holistic and less invasive method. Betaine, also known as trimethylglycine, is thought to enhance the breakdown of fats, while choline supports lipid metabolism and liver health. By incorporating these compounds, the treatments could provide a safer alternative with fewer side effects compared to conventional obesity medications.

What evidence suggests that betaine and choline might be effective treatments for obesity?

Studies have shown that betaine can help reduce body fat and improve body shape. In humans, it significantly lowers total body fat. Animal studies demonstrated that betaine reduces body weight and fat buildup. Research also suggests that betaine may help balance gut bacteria, potentially preventing obesity. This trial will provide participants with different treatments involving betaine, such as daily supplements with or without eggs, to evaluate its potential benefits for improving metabolic health in individuals who are overweight.34678

Are You a Good Fit for This Trial?

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

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

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
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+

Published Research Related to This Trial

In a study of 1938 adults aged 40-75, higher serum concentrations of choline were linked to less muscle mass loss in men and less fat gain in women with low baseline choline levels.
Similarly, higher serum betaine levels were associated with better maintenance of muscle mass and less fat gain in men with low baseline betaine concentrations, suggesting that both nutrients may positively influence body composition over a 3-year period.
Association between serum choline and betaine concentrations and longitudinal changes of body composition in community-dwelling middle-aged and older Chinese adults.Zhong, RH., Long, JA., Wang, F., et al.[2021]
In a study involving female APOE*3-Leiden.CETP mice fed a Western-type diet for 16 weeks, dietary choline supplementation significantly reduced body fat gain and prevented inflammation in adipose tissue.
Choline improved liver health by enhancing fatty acid oxidation and reducing cholesterol levels, suggesting a mechanism where it promotes the uptake of fatty acids from triglyceride-rich particles, leading to better cholesterol management.
Dietary choline increases brown adipose tissue activation markers and improves cholesterol metabolism in female APOE*3-Leiden.CETP mice.Liu, C., Song, Z., Li, Z., et al.[2023]
Betaine supplementation in heterozygous mice for 8 weeks improved conditions like hypertriglyceridemia and hepatic steatosis, suggesting it may help reduce obesity-related issues by enhancing lipid breakdown and metabolism.
The study identified specific metabolic changes linked to betaine, such as increased α-ketoglutaric acid and unique biomarkers like histidine and alanine, indicating its distinct mechanism of action compared to choline supplementation.
Betaine and Choline Improve Lipid Homeostasis in Obesity by Participation in Mitochondrial Oxidative Demethylation.Sivanesan, S., Taylor, A., Zhang, J., et al.[2020]

Citations

Effect of Betaine on Reducing Body Fat—A Systematic Review ...The results showed that supplemental betaine significantly reduced the total body fat mass and percentage in humans, but it had no significant ...
Association between dietary betaine intake and overweight ...In animal models, betaine treatment effectively reduced body weight and fat accumulation8,9.
Decoding Betaine: A Critical Analysis of Therapeutic ...Analysis of the results from human randomized clinical trials has shown that betaine supplementation improves body composition when combined with physical ...
The effects of chronic betaine supplementation on body ...The results of this study indicated that betaine supplementation may enhance reductions in fat mass, but not absolute strength, that accompany a resistance ...
Dietary betaine prevents obesity through gut microbiota- ...In summary, the results of this study show that dietary betaine alleviates gut microbiota imbalance in obese mice and reduces the development of obesity and ...
Beneficial Effects of Betaine: A Comprehensive Review - PMCSafety Studies with Betaine. Betaine is approved for human consumption based on the effectiveness with therapeutic equivalence by the FDA under sections 505 ...
Safety of betaine as a novel food pursuant to Regulation (EC ...A significant increase in total and low-density lipoprotein (LDL)-cholesterol concentrations was noted at intakes of 4 g/day of betaine in ...
Metabolic Effects of Betaine: A Randomized Clinical Trial of ...Dietary betaine supplementation reduces weight gain, levels of insulin under fasted and fed conditions, and hepatic fat, and increases whole-body glucose ...
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