Folate-Rich Foods Improve Folate Status (Folatefood)
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|ClinicalTrials.gov Identifier: NCT02373033|
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : February 26, 2015
|Condition or disease||Intervention/treatment||Phase|
|Folic Acid Deficiency||Other: Natural food folate Other: Folic acid Other: Apple juice||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||57 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||The Effects of a 3-months Dietary Intervention With Folate Enhanced Foods on Folate Status in Healthy Egyptian Women|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
Active Comparator: Intervention: Natural food folate
Food group consumed folate-rich foods (providing additional 250 μg/d folate).
Other: Natural food folate
Consumed folate-rich foods (providing additional 250 μg/d folate).
Other Name: Food folate
Active Comparator: Intervention: Folic acid
Folic acid group received a folic acid supplement (providing additional 500 μg/d folic acid).
Other: Folic acid
Received a folic acid supplement (providing additional 500 μg/d folic acid).
Placebo Comparator: Intervention: Control
Control group received apple juice containing no folate or folic acid every day.
Other: Apple juice
Received apple juice containing no folate or folic acid.
- 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
- Change in plasma total homocysteine [ Time Frame: (0 and 12 weeks) ]Assessment of plasma total homocysteine at baseline, 8 and 12 weeks
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373033
|Mansoura, Egypt, 35516|
|Principal Investigator:||Cornelia Witthöft, Prof||Dept of Food Science, Swedish University of Agricultural Sciences|