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Completed

NCT Number: NCT02373033

Folate-Rich Foods Improve Folate Status

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.

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Key information

Age range

19 year–32 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University

Al Mansurah, 35516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Natural food folate

Other

Consumed folate-rich foods (providing additional 250 μg/d folate).

Other names: Food folate

Folic acid

Other

Received a folic acid supplement (providing additional 500 μg/d folic acid).

Apple juice

Other

Received apple juice containing no folate or folic acid.

Primary outcomes

  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 outcomes

  1. Change in plasma total homocysteine

    Time frame: (0 and 12 weeks)

    Assessment of plasma total homocysteine at baseline, 8 and 12 weeks

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Collaborators

  • Swedish University of Agricultural Sciences
  • The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)

Registry information

Official study title

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

Acronym: Folatefood

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 26, 2015
Registry last updated
Feb 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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