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Obesity and Obesity-related Medical ConditionsNCT06758856

Effect of Betaine and Choline on Metabolic Health

A study testing Trimethylglycine, Eggs and Cellulose in people with Obesity and Obesity-related Medical Conditions, run by University of Guelph at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
What is being tested?
Trimethylglycine, Eggs and Cellulose
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
34 participants
Where
1 siteCanada
Study dates
31 Jan 2025to 19 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Human Nutraceutical Research Unit

    Guelph, Ontario, N1G 2W1

Other trials in Canada

About this study

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

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

Read the 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.

Being tested
Trimethylglycine, Eggs, Cellulose
Keywords
Betaine, Choline, Overweight, Obesity, Metabolism
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TrimethylglycineDietary supplement

    Betaine anhydrous from sugar beets

  • EggsOther

    3 whole eggs

  • CelluloseDietary supplement

    Cellulose

Study groups in NCT06758856
Study groupRoleWhat they receive
Daily 3 whole eggs with daily supplement containing 3 g trimethylglycineExperimentalNot described
Receives: Dietary Supplement: Trimethylglycine; Other: Eggs
Experimental: No eggs with daily supplement containing 3 g trimethylglycineExperimentalNot described
Receives: Dietary Supplement: Trimethylglycine
Placebo Comparator: No eggs with daily supplement containing 3 g cellulosePlacebo comparatorNot described
Receives: Dietary Supplement: Cellulose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lipid panel

    Triglyceride, cholesterol and lipoprotein concentrations

    Measured: Weeks 0, 4, 9 and 14

  2. Glucose concentrations

    Concentrations of glucose as mol units per volume

    Measured: Weeks 0, 4, 9 and 14

  3. Insulin concentrations

    Concentrations of insulin as international units per volume

    Measured: Weeks 0, 4, 9 and 14

  4. Concentrations of glucose metabolism panel

    Concentrations of C-peptide, GLP-1 and GIP as mol units per volume

    Measured: Weeks 0, 4, 9 and 14

  5. Body mass

    Mass on a scale

    Measured: Weeks 0, 4, 9 and 14

  6. One-carbon metabolism panel

    Choline metabolite concentrations

    Measured: Weeks 0, 4, 9 and 14

Secondary outcomes (8)

  1. Gene expression

    Global gene expression in isolated immune cells

    Measured: Weeks 0, 4, 9 and 14

  2. Inflammatory response in immune cells

    Expression of cytokines in immune cells as assessed in response to lipopolysaccharide challenge

    Measured: Weeks 0, 4, 9 and 14

  3. Composition of the gut microbiota

    Gut microbiota profiles as assessed by sequencing technologies

    Measured: Weeks 0, 4, 9 and 14

  4. Characterization of single nucleotide polymoprhisms

    Allelic discrimination of variants in enzymes that influence choline metabolites

    Measured: Week 0

  5. Liver health panel

    ALT, AST, GGT, ALP and bilirubin concentrations

    Measured: Weeks 0, 4, 9 and 14

  6. Blood cell counts

    Complete counts of white blood cell, red blood cell, hemoglobin, hematocrit and platelet

    Measured: Weeks 0, 4, 9 and 14

  7. Blood pressure

    Systolic and diastolic blood pressure

    Measured: Weeks 0, 4, 9 and 14

  8. Dietary intake

    24-hour prior day food record

    Measured: Weeks 0, 4, 9 and 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2025
  2. Study start31 Jan 2025
  3. Primary completion19 Aug 2025
  4. Study completion19 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06758856
Sponsor's protocol ID
24-03-006
Status last verified
May 2026
First submitted
18 Dec 2024
Last updated
12 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zeisel SH, da Costa KA. Choline: an essential nutrient for public health. Nutr Rev. 2009 Nov;67(11):615-23. doi: 10.1111/j.1753-4887.2009.00246.x.

    PubMed 19906248

  • Wallace TC, Blusztajn JK, Caudill MA, Klatt KC, Natker E, Zeisel SH, Zelman KM. Choline: The Underconsumed and Underappreciated Essential Nutrient. Nutr Today. 2018 Nov-Dec;53(6):240-253. doi: 10.1097/NT.0000000000000302. Epub 2018 Nov 13.

    PubMed 30853718

  • Lever M, Slow S. The clinical significance of betaine, an osmolyte with a key role in methyl group metabolism. Clin Biochem. 2010 Jun;43(9):732-44. doi: 10.1016/j.clinbiochem.2010.03.009. Epub 2010 Mar 25.

    PubMed 20346934

  • Craig SA. Betaine in human nutrition. Am J Clin Nutr. 2004 Sep;80(3):539-49. doi: 10.1093/ajcn/80.3.539.

    PubMed 15321791

  • Cho CE, Taesuwan S, Malysheva OV, Bender E, Tulchinsky NF, Yan J, Sutter JL, Caudill MA. Trimethylamine-N-oxide (TMAO) response to animal source foods varies among healthy young men and is influenced by their gut microbiota composition: A randomized controlled trial. Mol Nutr Food Res. 2017 Jan;61(1). doi: 10.1002/mnfr.201600324. Epub 2016 Aug 3.

    PubMed 27377678

  • Cho CE, Aardema NDJ, Bunnell ML, Larson DP, Aguilar SS, Bergeson JR, Malysheva OV, Caudill MA, Lefevre M. Effect of Choline Forms and Gut Microbiota Composition on Trimethylamine-N-Oxide Response in Healthy Men. Nutrients. 2020 Jul 25;12(8):2220. doi: 10.3390/nu12082220.

    PubMed 32722424

Questions about this trial

What is this clinical trial studying?

A study testing Trimethylglycine, Eggs and Cellulose in people with Obesity and Obesity-related Medical Conditions, run by University of Guelph at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lipid panel (time frame: Weeks 0, 4, 9 and 14). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06758856, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.

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