Folate-Rich Foods Improve Folate Status

Folic Acid Deficiency Clinical Trial

— Folatefood  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02373033
• Other study ID #: Formas Sida Dn 222-2009-1975
• Status: Completed
• Phase: N/A
• First received: February 3, 2015
• Last updated: February 20, 2015
• Start date: March 2013
• Est. completion date: June 2013

Study information

• Verified date: February 2015
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 32 Years

Eligibility

Inclusion Criteria:

Normal biochemical range for:

• Fasted plasma glucose

• Iron status (haemoglobin, serum ferritin)

• Liver status (aspartate transaminase, alanine transaminase, and ?-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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Folic Acid Deficiency

Intervention

Other:
• Natural food folate
Consumed folate-rich foods (providing additional 250 µg/d folate).
• Folic acid
Received a folic acid supplement (providing additional 500 µg/d folic acid).
• Apple juice
Received apple juice containing no folate or folic acid.

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansoura

Sponsors (3)

Lead Sponsor	Collaborator
Mansoura University	Swedish University of Agricultural Sciences, The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in plasma folate	Assessment of plasma folate at baseline, 8 and 12 weeks	(0 and 12 weeks)	No
Primary	Change in erythrocyte folate	Assessment of erythrocyte folate at baseline, 8 and 12 weeks	(0 and 12 weeks)	No
Secondary	Change in plasma total homocysteine	Assessment of plasma total homocysteine at baseline, 8 and 12 weeks	(0 and 12 weeks)	No