The Effects of 8-week Choline, Betaine, and Folic Acid Supplementation on Plasma Homocysteine Concentration During Guanidinoacetic Acid Loading in Young Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assoc. Prof. Sergej M. Ostojic, MD, PhD, Center for Health, Exercise and Sport Sciences, Serbia
ClinicalTrials.gov Identifier:
NCT01371357
First received: June 9, 2011
Last updated: December 18, 2011
Last verified: December 2011
  Purpose

A methyl-group acceptor such as guanidinoacetic acid (GAA) could induce hyperhomocysteinemia with the effects of GAA expected to be dose-dependent. Due to the fact that hyperhomocysteinemia is thought to be an independent risk factor for cardiovascular and neurodegenerative diseases, different dietary agents were used in the past for the treatment of elevated total plasma homocysteine (T-HCy), e. g. betaine, choline (betaine precursor) or folic acid. In the context of GAA loading the question arises whether intake of betaine, choline (betaine precursor) or folic acid during GAA loading could affect plasma T-HCy in healthy humans. Forty healthy physically active men and women aged 20 to 30 years will take part in this GAA-controlled, double-blind and parallel-group intervention study. Subjects will be allocated to four randomly assigned trials, with treatment lasting for 8 weeks and washout period of 28 days. The 4 test treatment-groups will include TEST1 (GAA only), TEST2 (GAA, choline, B6, B12 and folic acid), TEST3 (GAA, betaine, B6, B12 and folic acid) and TEST4 (GAA, B6, B12 and folic acid). Plasma T-HCy will be the primary outcome measure assessed every second week throughout the study. Plasma B-vitamins and blood and urine metabolites (GAA, creatine, methionine, arginine) will be secondary outcome measures along with adverse-effects indicators assessed every second week throughout the study. Selected body composition indicators will be obtained at 0, 2, 8 and 12 weeks throughout the study to monitor the effects of experimental treatments on body hydration and protein synthesis. This research will test the hypothesis that a combination of GAA with homocysteine lowering nutrients attenuates the elevation of T-hcy, and will further display the size-effect of each additive used.


Condition Intervention Phase
Hyperhomocysteinemia
Drug: TEST 1
Drug: TEST 2
Drug: TEST 3
Drug: TEST 4
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Center for Health, Exercise and Sport Sciences, Serbia:

Primary Outcome Measures:
  • Total plasma homocysteine [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Serum creatine [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: May 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TEST1
2.4 g/day of guanidinoacetic acid
Drug: TEST 1
2.4 g/day of guanidinoacetic acid
Experimental: TEST 2
2.4 g/day of guanidinoacetic acid + 3.0 g/day of choline dihydrogen citrate + 5 µg/day of B12 + 10 mg/day of B6 + 600 µg/day of folic acid
Drug: TEST 2
2.4 g/day of guanidinoacetic acid + 3.0 g/day of choline dihydrogencitrate + 5 µg/day of B12 + 10 mg/day of B6 + 600 µg/day of folic acid
Experimental: TEST 3
2.4 g/day of guanidinoacetic acid + 1.6 g/day of betaine HCl + 5 µg/day of B12 + 10 mg/day of B6 + 600 µg/day of folic acid
Drug: TEST 3
2.4 g/day of guanidinoacetic acid + 1.6 g/day of betaine HCl + 5 µg/day of B12 + 10 mg/day of B6 + 600 µg/day of folic acid
Experimental: TEST 4
2.4 g/day of guanidinoacetic acid + 5 µg/day of B12 + 10 mg/day of B6 + 600 µg/day of folic acid
Drug: TEST 4
2.4 g/day of guanidinoacetic acid + 5 µg/day of B12 + 10 mg/day of B6 + 600 µg/day of folic acid

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy male and non-pregnant females
  • moderately physically active
  • aged 20 to 30 years
  • not currently taking any dietary supplement for the past 2 months

Exclusion Criteria:

- total plasma homocysteine above 15.5 µmol/L

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01371357

Locations
Serbia
Center for Health, Exercise and Sport Sciences
Belgrade, Serbia, 11000
Sponsors and Collaborators
Center for Health, Exercise and Sport Sciences, Serbia
Investigators
Principal Investigator: Sergej M Ostojic, MD, PhD Center for Health, Exercise and Sport Sciences
  More Information

Additional Information:
Publications:
Responsible Party: Assoc. Prof. Sergej M. Ostojic, MD, PhD, Head of Exercise Physiology Lab, Center for Health, Exercise and Sport Sciences, Serbia
ClinicalTrials.gov Identifier: NCT01371357     History of Changes
Other Study ID Numbers: BN-214E-S10
Study First Received: June 9, 2011
Last Updated: December 18, 2011
Health Authority: Serbia: Ethics Committee

Keywords provided by Center for Health, Exercise and Sport Sciences, Serbia:
Remethylation
Human Subjects
Clinical Trial
B-vitamin
Creatine

Additional relevant MeSH terms:
Hyperhomocysteinemia
Amino Acid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Malabsorption Syndromes
Metabolic Diseases
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Folic Acid
Vitamin B Complex
Glycine
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Glycine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014