Back to resultsFolate-Rich Foods Improve Folate Status (Folatefood)
Primary Purpose
Folic Acid Deficiency
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Natural food folate
Folic acid
Apple juice
Sponsored by
About this trial
This is an interventional basic science trial for Folic Acid Deficiency focused on measuring Folate, folic acid, intervention trial, folate status, women in childbearing age, food folate
Eligibility Criteria
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
Sites / Locations
- Mansoura University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Intervention: Natural food folate
Intervention: Folic acid
Intervention: Control
Arm Description
Food group consumed folate-rich foods (providing additional 250 μg/d folate).
Folic acid group received a folic acid supplement (providing additional 500 μg/d folic acid).
Control group received apple juice containing no folate or folic acid every day.
Outcomes
Primary Outcome Measures
Change in plasma folate
Assessment of plasma folate at baseline, 8 and 12 weeks
Change in erythrocyte folate
Assessment of erythrocyte folate at baseline, 8 and 12 weeks
Secondary Outcome Measures
Change in plasma total homocysteine
Assessment of plasma total homocysteine at baseline, 8 and 12 weeks
Full Information
NCT ID
NCT02373033
First Posted
February 3, 2015
Last Updated
February 20, 2015
Sponsor
Mansoura University
Collaborators
Swedish University of Agricultural Sciences, The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
1. Study Identification
Unique Protocol Identification Number
NCT02373033
Brief Title
Folate-Rich Foods Improve Folate Status
Acronym
Folatefood
Official Title
The Effects of a 3-months Dietary Intervention With Folate Enhanced Foods on Folate Status in Healthy Egyptian Women
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
Collaborators
Swedish University of Agricultural Sciences, The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Folic Acid Deficiency
Keywords
Folate, folic acid, intervention trial, folate status, women in childbearing age, food folate
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention: Natural food folate
Arm Type
Active Comparator
Arm Description
Food group consumed folate-rich foods (providing additional 250 μg/d folate).
Arm Title
Intervention: Folic acid
Arm Type
Active Comparator
Arm Description
Folic acid group received a folic acid supplement (providing additional 500 μg/d folic acid).
Arm Title
Intervention: Control
Arm Type
Placebo Comparator
Arm Description
Control group received apple juice containing no folate or folic acid every day.
Intervention Type
Other
Intervention Name(s)
Natural food folate
Other Intervention Name(s)
Food folate
Intervention Description
Consumed folate-rich foods (providing additional 250 μg/d folate).
Intervention Type
Other
Intervention Name(s)
Folic acid
Intervention Description
Received a folic acid supplement (providing additional 500 μg/d folic acid).
Intervention Type
Other
Intervention Name(s)
Apple juice
Intervention Description
Received apple juice containing no folate or folic acid.
Primary Outcome Measure Information:
Title
Change in plasma folate
Description
Assessment of plasma folate at baseline, 8 and 12 weeks
Time Frame
(0 and 12 weeks)
Title
Change in erythrocyte folate
Description
Assessment of erythrocyte folate at baseline, 8 and 12 weeks
Time Frame
(0 and 12 weeks)
Secondary Outcome Measure Information:
Title
Change in plasma total homocysteine
Description
Assessment of plasma total homocysteine at baseline, 8 and 12 weeks
Time Frame
(0 and 12 weeks)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
32 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cornelia Witthöft, Prof
Organizational Affiliation
Dept of Food Science, Swedish University of Agricultural Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura University
City
Mansoura
ZIP/Postal Code
35516
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
19190070
Citation
Ohrvik VE, Olsson JC, Sundberg BE, Witthoft CM. Effect of 2 pieces of nutritional advice on folate status in Swedish women: a randomized controlled trial. Am J Clin Nutr. 2009 Apr;89(4):1053-8. doi: 10.3945/ajcn.2008.27192. Epub 2009 Feb 3.
Results Reference
result
Learn more about this trial
Folate-Rich Foods Improve Folate Status
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