The Effects of 8-week Choline, Betaine, and Folic Acid Supplementation on Plasma Homocysteine Concentration During Guanidinoacetic Acid Loading in Young Healthy Volunteers
Primary Purpose
Hyperhomocysteinemia
Status
Completed
Phase
Phase 3
Locations
Serbia
Study Type
Interventional
Intervention
TEST 1
TEST 2
TEST 3
TEST 4
Sponsored by
About this trial
This is an interventional treatment trial for Hyperhomocysteinemia focused on measuring Remethylation, Human Subjects, Clinical Trial, B-vitamin, Creatine
Eligibility 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
Sites / Locations
- Center for Health, Exercise and Sport Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
TEST1
TEST 2
TEST 3
TEST 4
Arm Description
2.4 g/day of guanidinoacetic acid
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
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
2.4 g/day of guanidinoacetic acid + 5 µg/day of B12 + 10 mg/day of B6 + 600 µg/day of folic acid
Outcomes
Primary Outcome Measures
Total plasma homocysteine
Secondary Outcome Measures
Serum creatine
Full Information
NCT ID
NCT01371357
First Posted
June 9, 2011
Last Updated
December 18, 2011
Sponsor
Center for Health, Exercise and Sport Sciences, Serbia
1. Study Identification
Unique Protocol Identification Number
NCT01371357
Brief Title
The Effects of 8-week Choline, Betaine, and Folic Acid Supplementation on Plasma Homocysteine Concentration During Guanidinoacetic Acid Loading in Young Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Center for Health, Exercise and Sport Sciences, Serbia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperhomocysteinemia
Keywords
Remethylation, Human Subjects, Clinical Trial, B-vitamin, Creatine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TEST1
Arm Type
Experimental
Arm Description
2.4 g/day of guanidinoacetic acid
Arm Title
TEST 2
Arm Type
Experimental
Arm Description
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
Arm Title
TEST 3
Arm Type
Experimental
Arm Description
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
Arm Title
TEST 4
Arm Type
Experimental
Arm Description
2.4 g/day of guanidinoacetic acid + 5 µg/day of B12 + 10 mg/day of B6 + 600 µg/day of folic acid
Intervention Type
Drug
Intervention Name(s)
TEST 1
Intervention Description
2.4 g/day of guanidinoacetic acid
Intervention Type
Drug
Intervention Name(s)
TEST 2
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
TEST 3
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
TEST 4
Intervention Description
2.4 g/day of guanidinoacetic acid + 5 µg/day of B12 + 10 mg/day of B6 + 600 µg/day of folic acid
Primary Outcome Measure Information:
Title
Total plasma homocysteine
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Serum creatine
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergej M Ostojic, MD, PhD
Organizational Affiliation
Center for Health, Exercise and Sport Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Health, Exercise and Sport Sciences
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
12. IPD Sharing Statement
Citations:
PubMed Identifier
16002808
Citation
Olthof MR, Brink EJ, Katan MB, Verhoef P. Choline supplemented as phosphatidylcholine decreases fasting and postmethionine-loading plasma homocysteine concentrations in healthy men. Am J Clin Nutr. 2005 Jul;82(1):111-7. doi: 10.1093/ajcn.82.1.111.
Results Reference
background
PubMed Identifier
18603787
Citation
Setoue M, Ohuchi S, Morita T, Sugiyama K. Hyperhomocysteinemia induced by guanidinoacetic acid is effectively suppressed by choline and betaine in rats. Biosci Biotechnol Biochem. 2008 Jul;72(7):1696-703. doi: 10.1271/bbb.70791. Epub 2008 Jul 7.
Results Reference
background
PubMed Identifier
16047264
Citation
Verhoef P, de Groot LC. Dietary determinants of plasma homocysteine concentrations. Semin Vasc Med. 2005 May;5(2):110-23. doi: 10.1055/s-2005-872397.
Results Reference
background
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The Effects of 8-week Choline, Betaine, and Folic Acid Supplementation on Plasma Homocysteine Concentration During Guanidinoacetic Acid Loading in Young Healthy Volunteers
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