Effect of Betaine, Serine and Folic Acid on Vascular Function in Healthy Volunteers
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Healthy Cardiovascular Diseases |
Procedure: supplementation with betaine, serine, and folic acid |
| 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 Plasma Homocysteine Concentrations After an Oral Methionine Load on Vascular Function in Healthy Volunteers |
- 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
- B-vitamins
- blood pressure
| Estimated Enrollment: | 40 |
| Study Start Date: | August 2002 |
| Estimated Study Completion Date: | July 2003 |
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.
Eligibility| Ages Eligible for Study: | 50 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| Netherlands | |
| Wageningen Centre for Food Sciences | |
| Wageningen, Netherlands | |
| Study Chair: | Petra Verhoef, PhD | Wageningen Centre for Food Sciences |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00126347 History of Changes |
| Other Study ID Numbers: | P02.0470L |
| Study First Received: | August 2, 2005 |
| Last Updated: | August 17, 2005 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Wageningen Centre for Food Sciences:
|
betaine serine folic acid methionine load |
homocysteine cardiovascular health vascular function human |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Betaine Folic Acid Vitamin B Complex Hematinics Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions Lipotropic Agents |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Hematologic Agents |
ClinicalTrials.gov processed this record on June 17, 2013