Clinical Trial: Folate-Rich Foods Improve Folate Status

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Effects of a 3-months Dietary Intervention With Folate Enhanced Foods on Folate Status in Healthy Egyptian Women

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 Summary:

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.


Sponsor: Mansoura University

Current Primary Outcome:

  • Change in plasma folate [ Time Frame: (0 and 12 weeks) ]
    Assessment of plasma folate at baseline, 8 and 12 weeks
  • Change in erythrocyte folate [ Time Frame: (0 and 12 weeks) ]
    Assessment of erythrocyte folate at baseline, 8 and 12 weeks


Original Primary Outcome: Same as current

Current Secondary Outcome: Change in plasma total homocysteine [ Time Frame: (0 and 12 weeks) ]

Assessment of plasma total homocysteine at baseline, 8 and 12 weeks


Original Secondary Outcome: Same as current

Information By: Mansoura University

Dates:
Date Received: February 3, 2015
Date Started: March 2013
Date Completion:
Last Updated: February 20, 2015
Last Verified: February 2015