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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

Tracking Information
First Submitted Date  ICMJE February 3, 2015
First Posted Date  ICMJE February 26, 2015
Last Update Posted Date February 26, 2015
Study Start Date  ICMJE March 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2015)
  • Change in plasma folate [ Time Frame: (0 and 12 weeks) ]
    Assessment of plasma folate at baseline, 8 and 12 weeks
  • Change in erythrocyte folate [ Time Frame: (0 and 12 weeks) ]
    Assessment of erythrocyte folate at baseline, 8 and 12 weeks
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2015)
Change in plasma total homocysteine [ Time Frame: (0 and 12 weeks) ]
Assessment of plasma total homocysteine at baseline, 8 and 12 weeks
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Folate-Rich Foods Improve Folate Status
Official Title  ICMJE The Effects of a 3-months Dietary Intervention With Folate Enhanced Foods on Folate Status in Healthy Egyptian Women
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Folic Acid Deficiency
Intervention  ICMJE
  • Other: Natural food folate
    Consumed folate-rich foods (providing additional 250 μg/d folate).
    Other Name: Food folate
  • Other: Folic acid
    Received a folic acid supplement (providing additional 500 μg/d folic acid).
  • Other: Apple juice
    Received apple juice containing no folate or folic acid.
Study Arms  ICMJE
  • Active Comparator: Intervention: Natural food folate
    Food group consumed folate-rich foods (providing additional 250 μg/d folate).
    Intervention: Other: Natural food folate
  • Active Comparator: Intervention: Folic acid
    Folic acid group received a folic acid supplement (providing additional 500 μg/d folic acid).
    Intervention: Other: Folic acid
  • Placebo Comparator: Intervention: Control
    Control group received apple juice containing no folate or folic acid every day.
    Intervention: Other: Apple juice
Publications * Ohrvik VE, Olsson JC, Sundberg BE, Witthöft 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 20, 2015)
57
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 19 Years to 32 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02373033
Other Study ID Numbers  ICMJE Formas Sida Dn 222-2009-1975
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mohammed Hefni, Mansoura University
Study Sponsor  ICMJE Mansoura University
Collaborators  ICMJE
  • Swedish University of Agricultural Sciences
  • The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
Investigators  ICMJE
Principal Investigator: Cornelia Witthöft, Prof Dept of Food Science, Swedish University of Agricultural Sciences
PRS Account Mansoura University
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP