Folatefood: Folate-Rich Foods Improve Folate Status

Sponsor

Mansoura University (Other)

Overall Status

Completed

CT.gov ID

NCT02373033

Collaborator

Swedish University of Agricultural Sciences (Other), The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS) (Other)

Enrollment

Location

Arms

Duration (Months)

18.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Folic Acid Deficiency	Other: Natural food folate Other: Folic acid Other: Apple juice	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

57 participants

Allocation:

Randomized

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 :

Mar 1, 2013

Actual Primary Completion Date :

Jun 1, 2013

Actual Study Completion Date :

Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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.

Arm

Intervention/Treatment

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 Names:

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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Change in plasma total homocysteine [(0 and 12 weeks)]
Assessment of plasma total homocysteine at baseline, 8 and 12 weeks

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 32 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura University	Mansoura		Egypt	35516

Sponsors and Collaborators

Mansoura University
Swedish University of Agricultural Sciences
The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)