The Effects of a 3-months Dietary Intervention With Folate Enhanced Foods on Folate Status in Healthy Egyptian Women
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mansoura University
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- Change in erythrocyte folate
Study Overview
Brief Summary
This study evaluates the effects of folate-rich foods regarding improvement of folate status compared with folic acid supplement. A randomized, parallel intervention trial with two active groups (folate-rich foods or folic acid supplement) and one control group (apple juice - 0 µg/d folate) was executed over 12 weeks.
Detailed Description
Sixty-two women in reproductive age, apparently healthy, non-smokers, not consuming special diets (vegetarian), not pregnant, not planning conception or not lactating.
A randomized, controlled, parallel intervention trial with two active groups and one blinded control group was carried out for 12 weeks (March to June, 2013). The active food group (n = 21) consumed folate-rich foods (germinated canned faba beans, cookies, orange juice, providing additional 250 μg/d folate); the active folic acid supplement group consumed a supplement (n = 19, providing 500 μg/d folic acid); and the control group (n = 22) received apple juice containing no folate or folic acid) in addition to the freely chosen diet.
Fasted venous blood samples were collected at baseline, two months and three months for quantification of folate in plasma and erythrocytes and of homocysteine in plasma.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 32 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Normal biochemical range for:
- •Fasted plasma glucose
- •Iron status (haemoglobin, serum ferritin)
- •Liver status (aspartate transaminase, alanine transaminase, and γ-glutamyl transferase activities)
- •Lipid profile (triglycerides, LDL, HDL)
- •Folate status (plasma and erythrocyte folate)
- •Plasma total homocysteine (tHcy)
- •Vitamin B-12
Exclusion Criteria
- •History of acute or chronic disease
- •Use of vitamin or mineral supplements or folic acid fortified foods (within the past one month)
- •A body mass index (BMI, in kg/m2) >18 and <30
- •Any medication interfering with folate metabolism (e.g., antiepileptic drugs, antibiotics, methotrexate, sulfasalazine, or anticonvulsants), smokers, consuming special diets (vegetarian), pregnancy, planned conception or lactation
Arms & Interventions
Intervention: Natural food folate
Food group consumed folate-rich foods (providing additional 250 μg/d folate).
Intervention: Natural food folate (Other)
Intervention: Control
Control group received apple juice containing no folate or folic acid every day.
Intervention: Apple juice (Other)
Intervention: Folic acid
Folic acid group received a folic acid supplement (providing additional 500 μg/d folic acid).
Intervention: Folic acid (Other)
Outcomes
Primary Outcomes
Change in erythrocyte folate
Time Frame: (0 and 12 weeks)
Assessment of erythrocyte folate at baseline, 8 and 12 weeks
Change in plasma folate
Time Frame: (0 and 12 weeks)
Assessment of plasma folate at baseline, 8 and 12 weeks
Secondary Outcomes
- Change in plasma total homocysteine((0 and 12 weeks))
Investigators
Mohammed Hefni
Dr
Mansoura University