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Folate-Rich Foods Improve Folate Status (Folatefood)

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ClinicalTrials.gov Identifier: NCT02373033
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : February 26, 2015
Sponsor:
Collaborators:
Swedish University of Agricultural Sciences
The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
Information provided by (Responsible Party):
Mohammed Hefni, 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.

Condition or disease Intervention/treatment Phase
Folic Acid Deficiency Other: Natural food folate Other: Folic acid Other: Apple juice Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
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 : March 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


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 Name: 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.




Primary Outcome Measures :
  1. Change in plasma folate [ Time Frame: (0 and 12 weeks) ]
    Assessment of plasma folate at baseline, 8 and 12 weeks

  2. Change in erythrocyte folate [ Time Frame: (0 and 12 weeks) ]
    Assessment of erythrocyte folate at baseline, 8 and 12 weeks


Secondary Outcome Measures :
  1. Change in plasma total homocysteine [ Time Frame: (0 and 12 weeks) ]
    Assessment of plasma total homocysteine at baseline, 8 and 12 weeks



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Ages Eligible for Study:   19 Years to 32 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373033


Locations
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Egypt
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)
Investigators
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Principal Investigator: Cornelia Witthöft, Prof Dept of Food Science, Swedish University of Agricultural Sciences

Publications of Results:
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Responsible Party: Mohammed Hefni, Dr, Mansoura University
ClinicalTrials.gov Identifier: NCT02373033     History of Changes
Other Study ID Numbers: Formas Sida Dn 222-2009-1975
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: February 26, 2015
Last Verified: February 2015
Keywords provided by Mohammed Hefni, Mansoura University:
Folate
folic acid
intervention trial
folate status
women in childbearing age
food folate
Additional relevant MeSH terms:
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Folic Acid Deficiency
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Folic Acid
Vitamin B Complex
Hematinics
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs