Folate-Rich Foods Improve Folate Status (Folatefood)

February 20, 2015 updated by: Mohammed Hefni, Mansoura University

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

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Mansoura, Egypt, 35516
        • Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 32 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention: Natural food folate
Food group consumed folate-rich foods (providing additional 250 μg/d 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).
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.
Received apple juice containing no folate or folic acid.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Cornelia Witthöft, Prof, Dept of Food Science, Swedish University of Agricultural Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

February 3, 2015

First Submitted That Met QC Criteria

February 20, 2015

First Posted (Estimate)

February 26, 2015

Study Record Updates

Last Update Posted (Estimate)

February 26, 2015

Last Update Submitted That Met QC Criteria

February 20, 2015

Last Verified

February 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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