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

August 2, 2005 updated by: Wageningen Centre for Food Sciences

Effect of Lowering of Fasting Plasma Homocysteine Concentrations Through Supplementation With Betaine or Folic Acid on Vascular Function in Healthy Volunteers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Wageningen, Netherlands, 6703 HD
        • Wageningen Centre for Food Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Concentrations of plasma homocysteine in fasting state
Vascular function, measured as flow mediated vasodilation, in fasting state

Secondary Outcome Measures

Outcome Measure
Blood pressure
B-vitamins
Lipid concentrations

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wageningen Centre for Food Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Study Completion

June 1, 2003

Study Registration Dates

First Submitted

February 3, 2005

First Submitted That Met QC Criteria

February 3, 2005

First Posted (ESTIMATE)

February 4, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

August 3, 2005

Last Update Submitted That Met QC Criteria

August 2, 2005

Last Verified

August 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P02.0505L

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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