Folate-Rich Foods Improve Folate Status

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Folic Acid Deficiency

Intervention / Treatment
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* Other: Natural food folate
* Other: Folic acid
* Other: Apple juice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 32 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention: Natural food folate<br>Food group consumed folate-rich foods (providing additional 250 μg/d folate). | Other: Natural food folate<br>* Consumed folate-rich foods (providing additional 250 μg/d folate).<br>* Other names: Food folate;|
| Active Comparator: Intervention: Folic acid<br>Folic acid group received a folic acid supplement (providing additional 500 μg/d folic acid). | Other: Folic acid<br>* Received a folic acid supplement (providing additional 500 μg/d folic acid).<br>|
| Placebo Comparator: Intervention: Control<br>Control group received apple juice containing no folate or folic acid every day. | Other: Apple juice<br>* Received apple juice containing no folate or folic acid.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plasma folate | Assessment of plasma folate at baseline, 8 and 12 weeks | (0 and 12 weeks) | 
| Change in erythrocyte folate | Assessment of erythrocyte folate at baseline, 8 and 12 weeks | (0 and 12 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plasma total homocysteine | Assessment of plasma total homocysteine at baseline, 8 and 12 weeks | (0 and 12 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Folate, folic acid, intervention trial, folate status, women in childbearing age, food folate