Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-01-01 @ 6:00 AM
Study NCT ID:
NCT06758856
Status:
RECRUITING
Last Update Posted:
2025-02-14
First Post:
2024-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Betaine and Choline on Metabolic Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001622', 'term': 'Betaine'}, {'id': 'D004531', 'term': 'Eggs'}, {'id': 'D002482', 'term': 'Cellulose'}], 'ancestors': [{'id': 'D050337', 'term': 'Trimethyl Ammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009861', 'term': 'Onium Compounds'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-12', 'studyFirstSubmitDate': '2024-12-18', 'studyFirstSubmitQcDate': '2025-01-02', 'lastUpdatePostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lipid panel', 'timeFrame': 'Weeks 0, 4, 9 and 14', 'description': 'Triglyceride, cholesterol and lipoprotein concentrations'}, {'measure': 'Glucose concentrations', 'timeFrame': 'Weeks 0, 4, 9 and 14', 'description': 'Concentrations of glucose as mol units per volume'}, {'measure': 'Insulin concentrations', 'timeFrame': 'Weeks 0, 4, 9 and 14', 'description': 'Concentrations of insulin as international units per volume'}, {'measure': 'Concentrations of glucose metabolism panel', 'timeFrame': 'Weeks 0, 4, 9 and 14', 'description': 'Concentrations of C-peptide, GLP-1 and GIP as mol units per volume'}, {'measure': 'Body mass', 'timeFrame': 'Weeks 0, 4, 9 and 14', 'description': 'Mass on a scale'}, {'measure': 'One-carbon metabolism panel', 'timeFrame': 'Weeks 0, 4, 9 and 14', 'description': 'Choline metabolite concentrations'}], 'secondaryOutcomes': [{'measure': 'Gene expression', 'timeFrame': 'Weeks 0, 4, 9 and 14', 'description': 'Global gene expression in isolated immune cells'}, {'measure': 'Inflammatory response in immune cells', 'timeFrame': 'Weeks 0, 4, 9 and 14', 'description': 'Expression of cytokines in immune cells as assessed in response to lipopolysaccharide challenge'}, {'measure': 'Composition of the gut microbiota', 'timeFrame': 'Weeks 0, 4, 9 and 14', 'description': 'Gut microbiota profiles as assessed by sequencing technologies'}, {'measure': 'Characterization of single nucleotide polymoprhisms', 'timeFrame': 'Week 0', 'description': 'Allelic discrimination of variants in enzymes that influence choline metabolites'}, {'measure': 'Liver health panel', 'timeFrame': 'Weeks 0, 4, 9 and 14', 'description': 'ALT, AST, GGT, ALP and bilirubin concentrations'}, {'measure': 'Blood cell counts', 'timeFrame': 'Weeks 0, 4, 9 and 14', 'description': 'Complete counts of white blood cell, red blood cell, hemoglobin, hematocrit and platelet'}, {'measure': 'Blood pressure', 'timeFrame': 'Weeks 0, 4, 9 and 14', 'description': 'Systolic and diastolic blood pressure'}, {'measure': 'Dietary intake', 'timeFrame': 'Weeks 0, 4, 9 and 14', 'description': '24-hour prior day food record'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Betaine', 'Choline', 'Overweight', 'Obesity', 'Metabolism'], 'conditions': ['Obesity and Obesity-related Medical Conditions']}, 'referencesModule': {'references': [{'pmid': '19906248', 'type': 'BACKGROUND', 'citation': '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': '30853718', 'type': 'BACKGROUND', 'citation': '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': '20346934', 'type': 'BACKGROUND', 'citation': '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': '15321791', 'type': 'BACKGROUND', 'citation': 'Craig SA. Betaine in human nutrition. Am J Clin Nutr. 2004 Sep;80(3):539-49. doi: 10.1093/ajcn/80.3.539.'}, {'pmid': '27377678', 'type': 'BACKGROUND', 'citation': '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': '32722424', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to determine whether extra betaine and choline influence metabolic health in adults with overweight and obesity.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female participant of any race or ethnicity between 18-70 years of age (inclusive) at the time of informed consent\n* BMI between 25-35 kg/m2\n* Non-smoker\n* Willing to consume 3 eggs per day for one dietary period of 4 weeks\n* Willing to avoid eggs during the rest of the study including washout period breaks except for eggs that are provided\n* Willing to fast before the baseline and dietary period lab visits\n* Willing to provide a 24-hr prior day food record at the dietary period lab visits\n* Willing to provide or collect biological specimen samples at the baseline and dietary period lab visits\n* Willing to follow the study protocol including maintaining usual lifestyle during the entire study\n\nExclusion Criteria:\n\n* Male or female \\< 18 years or \\> 70 years of age at the time of consent\n* BMI \\< 25 kg/m2; or BMI \\> 35 kg/m2\n* Pregnant or planning to become pregnant during the course of the study; currently breastfeeding or postpartum \\< 6 months\n* Use of hormone therapy including birth control pills\n* Follows a vegan diet\n* Current smoker (any form of nicotine, e-cigarettes, etc)\n* Use of recreational drugs (may affect metabolic pathway for choline)\n* 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\n* Diagnosis of trimethylaminuria (genetic disorder affecting choline use in body)\n* Use of antibiotics in the last 2 months\n* Use of prebiotics, probiotics or dietary fiber (i.e., Metamucil) supplements in the last 2 months\n* Have allergies to eggs or any anaphylactic food allergies\n* Have a schedule or lifestyle patterns incompatible with the study protocol"}, 'identificationModule': {'nctId': 'NCT06758856', 'briefTitle': 'Effect of Betaine and Choline on Metabolic Health', 'organization': {'class': 'OTHER', 'fullName': 'University of Guelph'}, 'officialTitle': 'ABC (Additional Betaine and Choline) Study: Effect of Betaine and Choline Intake on Biomarkers of Metabolic Health in Humans', 'orgStudyIdInfo': {'id': '24-03-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Daily 3 whole eggs with daily supplement containing 3 g trimethylglycine', 'interventionNames': ['Dietary Supplement: Trimethylglycine', 'Other: Eggs']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental: No eggs with daily supplement containing 3 g trimethylglycine', 'interventionNames': ['Dietary Supplement: Trimethylglycine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Comparator: No eggs with daily supplement containing 3 g cellulose', 'interventionNames': ['Dietary Supplement: Cellulose']}], 'interventions': [{'name': 'Trimethylglycine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Betaine anhydrous from sugar beets', 'armGroupLabels': ['Daily 3 whole eggs with daily supplement containing 3 g trimethylglycine', 'Experimental: No eggs with daily supplement containing 3 g trimethylglycine']}, {'name': 'Eggs', 'type': 'OTHER', 'description': '3 whole eggs', 'armGroupLabels': ['Daily 3 whole eggs with daily supplement containing 3 g trimethylglycine']}, {'name': 'Cellulose', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Cellulose', 'armGroupLabels': ['Placebo Comparator: No eggs with daily supplement containing 3 g cellulose']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N1G 2W1', 'city': 'Guelph', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Amy Tucker, PhD', 'role': 'CONTACT', 'email': 'hnru@uoguelph.ca', 'phone': '519-824-4120', 'phoneExt': '53749'}, {'name': 'Clara E. Cho, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Alison M. Duncan, RD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Human Nutraceutical Research Unit', 'geoPoint': {'lat': 43.54594, 'lon': -80.25599}}], 'centralContacts': [{'name': 'Clara E. Cho, PhD', 'role': 'CONTACT', 'email': 'claracho@uoguelph.ca', 'phone': '519-824-4120', 'phoneExt': '53743'}, {'name': 'Alison M. Duncan, RD, PhD', 'role': 'CONTACT', 'email': 'amduncan@uoguelph.ca', 'phone': '519-824-4120', 'phoneExt': '53416'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Guelph', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Clara Cho', 'investigatorAffiliation': 'University of Guelph'}}}}