Effect of Betaine, Serine and Folic Acid on Vascular Function in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00126347
Recruitment Status : Completed
First Posted : August 3, 2005
Last Update Posted : August 18, 2005
Information provided by:
Wageningen Centre for Food Sciences

August 2, 2005
August 3, 2005
August 18, 2005
August 2002
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  • concentrations of plasma homocysteine before and following an oral methionine load
  • vascular function, measured as flow mediated vasodilation before and following an oral methionine load
Same as current
Complete list of historical versions of study NCT00126347 on Archive Site
  • B-vitamins
  • blood pressure
Same as current
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Effect of Betaine, Serine and Folic Acid on Vascular Function in Healthy Volunteers
Effect of Lowering of Plasma Homocysteine Concentrations After an Oral Methionine Load on Vascular Function in Healthy Volunteers
The purpose of this study is to determine whether reducing the increase in plasma homocysteine concentrations following an oral methionine load affects vascular function in healthy volunteers, irrespective of the homocysteine-lowering agent.

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. The researchers investigated whether reduction in homocysteine concentrations following a methionine load, via supplementation with serine, 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: The effects of supplementation with serine, folic acid and betaine (all together with an oral methionine load) were compared to the effects of a placebo (together with a methionine load) on plasma homocysteine concentrations and on vascular function following methionine loading in healthy volunteers.

Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Prevention
  • Healthy
  • Cardiovascular Diseases
Procedure: supplementation with betaine, serine, and folic acid
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
July 2003
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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, lipids, vitamin B6, vitamin B12, folic acid, 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 a 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 plasmapherese 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 know to interfere with the study
  • Fasting plasma total homocysteine > 26 micromol/L
  • Alcohol consumption: women >21 consumptions/week; men >28 consumptions/week
  • 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 a 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.
Sexes Eligible for Study: All
50 Years to 70 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Wageningen Centre for Food Sciences
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Study Chair: Petra Verhoef, PhD Wageningen Centre for Food Sciences
Wageningen Centre for Food Sciences
August 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP