Folate-Rich Foods Improve Folate Status

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02373033

Acronym

Folatefood

Enrollment

Registered

2015-02-26

Start date

2013-03-31

Completion date

2013-06-30

Last updated

2015-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Folic Acid Deficiency

Keywords

Folate, folic acid, intervention trial, folate status, women in childbearing age, food folate

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.

Interventions

OTHERNatural food folate

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

OTHERFolic acid

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

OTHERApple juice

Received apple juice containing no folate or folic acid.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

19 Years to 32 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026