Folate-Rich Foods Improve Folate Status (Folatefood)

Mansoura University

Status: Completed

Conditions: Folic Acid Deficiency

Treatments: Other: Folic acid; Other: Apple juice; Other: Natural food folate

Study type: Interventional

Funder types: Other

Identifiers

NCT02373033

Formas Sida Dn 222-2009-1975

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: Female

Ages: 19 to 32 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 3 patient groups, including a placebo group

Intervention: Natural food folate

Active Comparator group

Description:

Food group consumed folate-rich foods (providing additional 250 μg/d folate).

Treatment:

Other: Natural food folate

Intervention: Folic acid

Active Comparator group

Description:

Folic acid group received a folic acid supplement (providing additional 500 μg/d folic acid).

Treatment:

Other: Folic acid

Intervention: Control

Placebo Comparator group

Description:

Control group received apple juice containing no folate or folic acid every day.

Treatment:

Other: Apple juice