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

NCT00126347 | Completed

• 1 other identifier: P02.0470L
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy; Cardiovascular Diseases

Keywords

betaine; serine; folic acid; methionine load; homocysteine; cardiovascular health; vascular function; human

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• B-vitamins

• blood pressure

Interventions

supplementation with betaine, serine, and folic acid PROCEDURE

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Wageningen Centre for Food Sciences: lead

Study Sites (1)

Wageningen Centre for Food Sciences

Wageningen, Netherlands

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Dietary Supplements; Betaine; Serine; Folic Acid

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Petra Verhoef, PhD

  Wageningen Centre for Food Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 2, 2005
• First Posted: August 3, 2005
• Study Start: August 1, 2002
• Study Completion: July 1, 2003
• Last Updated: August 18, 2005

Record last verified: 2005-08

Locations

NL (1)