NCT01661309CompletedNot Applicable
To Critically Investigate and Evaluate Supplementary Vitamin B12 Effects on Elevated Homocysteine Levels of Vegetarians, Who May Have a Resultant Susceptibility to Hyperhomocysteinemia Related Diseases.
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of West London
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Reduction of plasma total homocysteine of vegetarians
Study Overview
Brief Summary
Vegetarians are known to be deficient in vitamin B12, due to a lack or absence of dietary animal produce, which can elevate homocysteine. There is strong evidence indicating that elevated plasma total homocysteine (tHcy) is a contributor to chronic conditions, such as primary cardiovascular disease (CVD). The study hypothesis is: There will be a significant decrease in plasma tHcy of vegetarians following the intervention by supplementary vitamin B12 (of the methylcobalamin type) and this will lead to a reduction of the risk of CVD.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Having a plasma tHcy >10 micromol/L
- •Not suffering from conditions as described in exclusion criteria.
- •Vegetarian for at least one year.
- •Not participating in a weight reducing diet.
- •Not consuming regularly vitamin B12 supplements.
- •Give written consent to participate in clinical trial and be fluent in English language.
Exclusion Criteria
- •Having a plasma tHcy less or equal to 10 micromol/L.
- •Suffering from pernicious anemia or other vitamin B12 deficiency disease.
- •Undergone bowel surgery or suffer from gastrointestinal disease.
- •Pregnant, lactating or trying to conceive.
- •Alcohol intake regularly greater than official recommended daily units (i.e. 2 units female, 3 units male).
- •Consume large amounts of caffeine (regular consumption of >4 cups of strong tea or coffee per day).
- •Use of medications known to influence nutritional status.
- •Have genetic metabolic disease.
- •Suffer from renal failure, diabetes, thyroid disease, cardiovascular disease, dementia or cancer.
- •Have a known blood-borne infection (e.g. Hepatitis or HIV).
Outcomes
Primary Outcomes
Reduction of plasma total homocysteine of vegetarians
Time Frame: 16 weeks per participant
Secondary Outcomes
- Improvement in systolic and diastolic blood pressure(16 weeks per participant)
Investigators
Derek Obersby
PhD Student
University of West London
Study Sites (2)
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