Folate-Rich Foods Improve Folate Status

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-06-30

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.

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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.

Conditions

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Folic Acid Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Intervention: Natural food folate

Food group consumed folate-rich foods (providing additional 250 μg/d folate).

Group Type ACTIVE_COMPARATOR

Natural food folate

Intervention Type OTHER

Consumed folate-rich foods (providing additional 250 μg/d folate).

Intervention: Folic acid

Folic acid group received a folic acid supplement (providing additional 500 μg/d folic acid).

Group Type ACTIVE_COMPARATOR

Folic acid

Intervention Type OTHER

Received a folic acid supplement (providing additional 500 μg/d folic acid).

Intervention: Control

Control group received apple juice containing no folate or folic acid every day.

Group Type PLACEBO_COMPARATOR

Apple juice

Intervention Type OTHER

Received apple juice containing no folate or folic acid.

Interventions

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Natural food folate

Consumed folate-rich foods (providing additional 250 μg/d folate).

Intervention Type OTHER

Folic acid

Received a folic acid supplement (providing additional 500 μg/d folic acid).

Intervention Type OTHER

Apple juice

Received apple juice containing no folate or folic acid.

Intervention Type OTHER

Other Intervention Names

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Food folate

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

Minimum Eligible Age

19 Years

Maximum Eligible Age

32 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes