Folate-Rich Foods Improve Folate Status

Not Applicable

Completed

• Conditions: Folic Acid Deficiency
• Interventions: Other: Natural food folate; Other: Apple juice; Other: Folic acid

• Registration Number: NCT02373033
• Lead Sponsor: Mansoura University

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.

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2015-02
• Study First Submitted: 2015-02-03
• Study First Submitted QC: 2015-02-20
• Last Update Submitted: 2015-02-20
• Study First Posted: 2015-02-26
• Last Update Posted: 2015-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 57

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention: Natural food folate	Natural food folate	Food group consumed folate-rich foods (providing additional 250 μg/d folate).
Intervention: Control	Apple juice	Control group received apple juice containing no folate or folic acid every day.
Intervention: Folic acid	Folic acid	Folic acid group received a folic acid supplement (providing additional 500 μg/d folic acid).

Primary Outcome Measures

Name	Time	Method
Change in erythrocyte folate	(0 and 12 weeks)	Assessment of erythrocyte folate at baseline, 8 and 12 weeks
Change in plasma folate	(0 and 12 weeks)	Assessment of plasma folate at baseline, 8 and 12 weeks

Secondary Outcome Measures

Name	Time	Method
Change in plasma total homocysteine	(0 and 12 weeks)	Assessment of plasma total homocysteine at baseline, 8 and 12 weeks

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansoura, Egypt