Effect of Betaine and Choline on Metabolic Health

NCT06758856 | Recruiting

• 1 other identifier: 24-03-006
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity and Obesity-related Medical Conditions

Keywords

Betaine; Choline; Overweight; Obesity; Metabolism

Outcome Measures

Primary Outcomes (6)

• Lipid panel

  Triglyceride, cholesterol and lipoprotein concentrations

  Weeks 0, 4, 9 and 14

• Glucose concentrations

  Concentrations of glucose as mol units per volume

  Weeks 0, 4, 9 and 14

• Insulin concentrations

  Concentrations of insulin as international units per volume

  Weeks 0, 4, 9 and 14

• Concentrations of glucose metabolism panel

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

  Weeks 0, 4, 9 and 14

• Body mass

  Mass on a scale

  Weeks 0, 4, 9 and 14

• One-carbon metabolism panel

  Choline metabolite concentrations

  Weeks 0, 4, 9 and 14

Secondary Outcomes (8)

• Gene expression

  Weeks 0, 4, 9 and 14

• Inflammatory response in immune cells

  Weeks 0, 4, 9 and 14

• Composition of the gut microbiota

  Weeks 0, 4, 9 and 14

• Characterization of single nucleotide polymoprhisms

  Week 0

• Liver health panel

  Weeks 0, 4, 9 and 14

Study Arms (3)

Daily 3 whole eggs with daily supplement containing 3 g trimethylglycine

EXPERIMENTAL

Dietary Supplement: Trimethylglycine; Other: Eggs

Experimental: No eggs with daily supplement containing 3 g trimethylglycine

EXPERIMENTAL

Dietary Supplement: Trimethylglycine

Placebo Comparator: No eggs with daily supplement containing 3 g cellulose

PLACEBO COMPARATOR

Dietary Supplement: Cellulose

Interventions

Trimethylglycine DIETARY_SUPPLEMENT

Betaine anhydrous from sugar beets

Daily 3 whole eggs with daily supplement containing 3 g trimethylglycine; Experimental: No eggs with daily supplement containing 3 g trimethylglycine

Eggs OTHER

3 whole eggs

Daily 3 whole eggs with daily supplement containing 3 g trimethylglycine

Cellulose DIETARY_SUPPLEMENT

Cellulose

Placebo Comparator: No eggs with daily supplement containing 3 g cellulose

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Guelph: lead

Study Sites (1)

Human Nutraceutical Research Unit

Guelph, Ontario, N1G 2W1, Canada

RECRUITING

Related Publications (6)

• 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.

  PMID: 19906248 BACKGROUND

• 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.

  PMID: 30853718 BACKGROUND

• 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.

  PMID: 20346934 BACKGROUND

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

  PMID: 15321791 BACKGROUND

• 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.

  PMID: 27377678 BACKGROUND

• 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.

  PMID: 32722424 BACKGROUND

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Betaine; Eggs; Cellulose

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Clara E. Cho, PhD

CONTACT

519-824-4120; claracho@uoguelph.ca

Alison M. Duncan, RD, PhD

CONTACT

519-824-4120; amduncan@uoguelph.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Supplements will be double-blinded, which the order of dietary periods will not be revealed to participants until after the study is completed. Care provider, investigator and outcomes assessor who will be involved in collecting study data will not know the supplement assignment.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: January 6, 2025
• Study Start: January 31, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 14, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)