Clinical trial NCT02373033: Folate-Rich Foods Improve Folate Status
Official title: The Effects of a 3-months Dietary Intervention With Folate Enhanced Foods on Folate Status in Healthy Egyptian Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Folic Acid Deficiency
Keywords: Folate
folic acid
intervention trial
folate status
women in childbearing age
food folate
Lead sponsor: Mansoura University
Sponsor class: OTHER
Collaborators: name: Swedish University of Agricultural Sciences
name: The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
First posted: 2015-02-26
Enrollment: 57
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 32
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Change in plasma folate
timeFrame: (0 and 12 weeks)
measure: Change in erythrocyte folate
timeFrame: (0 and 12 weeks)
Secondary outcomes:
measure: Change in plasma total homocysteine
timeFrame: (0 and 12 weeks)
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
Study officials:
affiliation: Dept of Food Science, Swedish University of Agricultural Sciences
name: Cornelia Witthöft, Prof
role: PRINCIPAL_INVESTIGATOR
References:
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.