- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02373033
Folate-Rich Foods Improve Folate Status (Folatefood)
The Effects of a 3-months Dietary Intervention With Folate Enhanced Foods on Folate Status in Healthy Egyptian Women
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Mansoura, Egypt, 35516
- Mansoura University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Intervention: Natural food folate
Food group consumed folate-rich foods (providing additional 250 μg/d folate).
|
Consumed folate-rich foods (providing additional 250 μg/d folate).
Other Names:
|
Active Comparator: Intervention: Folic acid
Folic acid group received a folic acid supplement (providing additional 500 μg/d folic acid).
|
Received a folic acid supplement (providing additional 500 μg/d folic acid).
|
Placebo Comparator: Intervention: Control
Control group received apple juice containing no folate or folic acid every day.
|
Received apple juice containing no folate or folic acid.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in plasma folate
Time Frame: (0 and 12 weeks)
|
Assessment of plasma folate at baseline, 8 and 12 weeks
|
(0 and 12 weeks)
|
Change in erythrocyte folate
Time Frame: (0 and 12 weeks)
|
Assessment of erythrocyte folate at baseline, 8 and 12 weeks
|
(0 and 12 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in plasma total homocysteine
Time Frame: (0 and 12 weeks)
|
Assessment of plasma total homocysteine at baseline, 8 and 12 weeks
|
(0 and 12 weeks)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Cornelia Witthöft, Prof, Dept of Food Science, Swedish University of Agricultural Sciences
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Formas Sida Dn 222-2009-1975
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Folic Acid Deficiency
-
Hadassah Medical OrganizationUnknown
-
Indonesia UniversityUnited States Agency for International Development (USAID); Ministry of Research...Completed
-
Harvard UniversityCompleted
-
Oklahoma State University Center for Health SciencesActive, not recruiting
-
National Institute of Health and NutritionCompletedFolate Deficiency
-
University Hospital, Strasbourg, FranceCompletedFolic Acid Deficiency | Elderly Patients | Social IsolationFrance
-
Meir Medical CenterCompletedFolic Acid Deficiency | Vitamin B12 DeficiencyIsrael
-
University of TorontoThe Hospital for Sick Children; Heinz EndowmentsCompletedIron Deficiency | Folic Acid DeficiencyCanada
-
Medical University of GrazCompletedHealthy | Oxidative Stress | Vitamin B 12 Deficiency | Polyphenols | Thiamine and Niacin Deficiency States | Pyridoxine Deficiency | Folic Acid Deficiency Anemia, Dietary | Peroxidase; Defect | Homocystine; Metabolic DisorderAustria
-
Walden UniversityCompletedPregnancy Related | Autism Spectrum Disorder | Autistic Disorder | Folate Deficiency | Folic Acid Deficiency | Diet, Healthy | Autism | Diet; Deficiency | Folic Acid OverdoseUnited States
Clinical Trials on Natural food folate
-
Pennington Biomedical Research CenterOhio State UniversityCompleted
-
Cornell UniversityLaidlaw Foundation; Epperson Fund; Beck Fellowship; Dan Cane FundCompletedPolycystic Ovary Syndrome | Ovarian Cysts | PCOS | Dysmenorrhea | Menstrual Pain | Premenstrual Dysphoric Disorder | Premenstrual Syndrome | Period Pain | Menstrual Problem | PMS | Menstrual Discomfort | Dysmenorrhea Primary | Cramps | Menstrual Cycle Abnormal | PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries | Period... and other conditionsUnited States
-
University of Mississippi, OxfordWalgreen'sCompleted
-
Shaare Zedek Medical CenterUnknown
-
Sprim Advanced Life SciencesArtsana S.p.a.CompletedFeeding Behavior
-
Wenxiang WangShanghai Houchao Biotechnology Co., LtdUnknownNon-small Cell Lung CancerChina
-
Hampton VA Medical CenterCompletedPersonality Disorders | Depression | Bipolar Disorder | Substance Use Disorders | PsychosisUnited States
-
Mount Saint Vincent UniversityCompletedBlood Glucose | Eating | Food | AppetiteCanada
-
Alpha - Bio Tec Ltd.Unknown
-
Acibadem UniversityUnknownInfertility, FemaleTurkey