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

NCT00102843 | Completed

• 1 other identifier: P02.0505L
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy; Cardiovascular Diseases

Keywords

folic acid; betaine; homocysteine; cardiovascular disease prevention; human; Cardiovascular health

Outcome Measures

Primary Outcomes (2)

• Concentrations of plasma homocysteine in fasting state

• Vascular function, measured as flow mediated vasodilation, in fasting state

Secondary Outcomes (3)

• Lipid concentrations

• B-vitamins

• Blood pressure

Interventions

supplementation with folic acid and betaine 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, 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.

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 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.
• 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, 6703 HD, Netherlands

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Dietary Supplements; Folic Acid; Betaine

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium 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: February 3, 2005
• First Posted: February 4, 2005
• Study Start: October 1, 2002
• Study Completion: June 1, 2003
• Last Updated: August 3, 2005

Record last verified: 2005-08

Locations

NL (1)