Effect of Betaine and Folic Acid on Vascular Function in Healthy Humans

This study has been completed.
Sponsor:
Information provided by:
Wageningen Centre for Food Sciences
ClinicalTrials.gov Identifier:
NCT00102843
First received: February 3, 2005
Last updated: August 2, 2005
Last verified: August 2005
  Purpose

The purpose of this study is to determine whether lowering of fasting homocysteine concentrations improves vascular function in healthy volunteers, irrespective of the homocysteine-lowering agent.


Condition Intervention
Healthy
Cardiovascular Diseases
Procedure: supplementation with folic acid and betaine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Effect of Lowering of Fasting Plasma Homocysteine Concentrations Through Supplementation With Betaine or Folic Acid on Vascular Function in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Wageningen Centre for Food Sciences:

Primary Outcome Measures:
  • Concentrations of plasma homocysteine in fasting state
  • Vascular function, measured as flow mediated vasodilation, in fasting state

Secondary Outcome Measures:
  • Lipid concentrations
  • B-vitamins
  • Blood pressure

Estimated Enrollment: 40
Study Start Date: October 2002
Estimated Study Completion Date: June 2003
Detailed Description:

A high plasma homocysteine is a potential risk factor for cardiovascular disease and death. However, it remains uncertain whether homocysteine per se, low status of folate, or other factors related to methionine metabolism are involved in the pathogenesis of cardiovascular disease. Previous studies have shown that a high concentration of homocysteine in blood is related to an impaired vascular function in the arteries, an indicator of cardiovascular disease risk. Virtually all intervention trials used folic acid as a homocysteine-lowering agent, which may however affect vascular function through mechanisms not related to homocysteine. We investigated whether lowering of fasting homocysteine concentrations via supplementation with betaine or folic acid improves vascular function in healthy volunteers, in order to distinguish between effects of folic acid and of homocysteine-lowering per se.

Comparison: We compare the effects of supplementation with folic acid to the effects of betaine, and to the effects of a placebo on plasma homocysteine concentrations and vascular function in healthy humans.

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Apparently healthy.
  • Women postmenopausal: two or more years after last menstruation. If the uterus was surgically removed, the women must be 55 years or older.
  • Normal blood values for: hematology, total homocysteine, blood lipids, vitamin B6, vitamin B12, folate, liver enzymes, creatinine.
  • Absence of protein and glucose in urine sample.
  • Body mass index (BMI) between 18 and 30 kg/m2.
  • Good ultrasound visibility of the brachial artery, judged by the sonographer.
  • Willing not to use supplements containing B-vitamins, antioxidant vitamins (A, beta-carotene, C and E) or n-3 fatty acids/fish oil supplements from screening day (>2 months before start of the study) until end of study.
  • Willing not to be blood or plasmapheresis donor from 4 weeks before the screening day, and 4 weeks before the start of the study until the end of study.

Exclusion Criteria:

  • Any chronic or acute disease (e.g. diabetes, renal disease, inflammation).
  • Current, or history of cardiovascular disease.
  • Hypertension.
  • Medical history or surgical events known to interfere with the study.
  • Fasting plasma total homocysteine > 26 micromol/L.
  • Alcohol consumption: more than 21 consumptions /week for women, and more than 28 consumptions/week for men.
  • Weight loss or gain > 2 kg in the month prior to screening.
  • Any special diet (prescribed, slimming, macrobiotic or total vegetarian). Sole exclusion of meat and fish from an otherwise ‘normal’ western diet is allowed.
  • Lactose intolerance.
  • Use of supplements containing B-vitamins more than once weekly in the period from 3 months before the screening day.
  • Participation in any other trial up to 3 months before this study.
  • Use of medication known to interfere with the study outcome.
  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: NCT00102843

Locations
Netherlands
Wageningen Centre for Food Sciences
Wageningen, Netherlands, 6703 HD
Sponsors and Collaborators
Wageningen Centre for Food Sciences
Investigators
Study Chair: Petra Verhoef, PhD Wageningen Centre for Food Sciences
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00102843     History of Changes
Other Study ID Numbers: P02.0505L
Study First Received: February 3, 2005
Last Updated: August 2, 2005
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Wageningen Centre for Food Sciences:
folic acid
betaine
homocysteine
cardiovascular disease prevention
human
Cardiovascular health

Additional relevant MeSH terms:
Cardiovascular Diseases
Folic Acid
Vitamin B Complex
Betaine
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Gastrointestinal Agents
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents

ClinicalTrials.gov processed this record on September 18, 2014