A Functional Food for the Prevention of Iron-deficiency Anemia
Primary Purpose
Anemia
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Control bread
Teff Bread
Sponsored by
About this trial
This is an interventional prevention trial for Anemia focused on measuring iron, bioavailability, status, deficiency, anaemia, functional foods, child bearing
Eligibility Criteria
Inclusion Criteria:
- Caucasian
- Primiparous
- Singleton pregnancy (wk 20 to wk 30)
- Non smokers
- Pre pregnancy BMI between 19.8 and 26
- Healthy, free from iron metabolism disorders (pregnancy induced hypertension
- Not taking medicines known to influence iron status
- Not taking iron supplements (multivitamins will be accounted for)
- Free from gastrointestinal disorders
- No allergies
Exclusion Criteria:
- Pregnancy haemoglobin concentrations are not within the normal range (below 70g/l or over 160g/l)
Sites / Locations
- Manchester Food Research Centre, Manchester Metropolitan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Control
Teff bread
Arm Description
Control bread
Teff bread
Outcomes
Primary Outcome Measures
To develop Teff bread that is rich in iron (per slice).
To establish whether iron from Teff is bioavailable.
To conclude whether daily Teff consumption prevents iron-deficiency anemia in pregnancy.
Secondary Outcome Measures
To use a range of different biomarkers to determine iron status.
To compare dietary intakes of iron and iron status between the Teff/control group.
Full Information
NCT ID
NCT01055431
First Posted
January 22, 2010
Last Updated
July 29, 2014
Sponsor
Manchester Metropolitan University
1. Study Identification
Unique Protocol Identification Number
NCT01055431
Brief Title
A Functional Food for the Prevention of Iron-deficiency Anemia
Official Title
Teff (Eragrostis Tef) as a Functional Food for the Prevention of Pregnancy Iron-deficiency Anemia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Manchester Metropolitan University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
It has been estimated that 1 in 2 women expecting a baby will be diagnosed with iron deficiency. In turn iron deficiency can affect the health and wellbeing or both mother and child. Studies show that low iron stores prior to conception and low iron intakes during pregnancy may both be contributing to this problem. Although dietary supplements may be one solution, research indicates that daily compliance is low (Nguyen et al., 2008). Furthermore, prescribed iron supplements may result in uncomfortable side-effects, including constipation (Wulff & Ekstrom, 2003).
It is been observed in Ethiopia that iron deficiency anemia is lower than average; a finding that has been attributed to regular "Teff" consumption (Gies et al., 2003). Teff (Eragrostis tef) is a staple food usually consumed in the form of Enjera (flat bread prepared using a range of cereals). Research has shown that Teff is a rich source of iron that is easily absorbed by the body.
Although it is believed that regular Teff consumption may prevent to onset of iron deficiency anemia there is no research to support this. Therefore, the aim of the present study is to es-tablish whether incorporating Teff into the daily diet may be one way to improve blood profile and prevent the onset of iron deficiency anemia in expectant mothers. Study findings will demonstrate whether Teff may be an alternative source of iron that can be easily incorporated into the daily diet of both pregnant mothers and the lay public.
Detailed Description
Rationale Iron deficiency anemia is considered to be one of the most prevalent forms of malnutrition in Europe (Stoltzfus, 2003 & Hercberg et al., 2001). Pregnant mothers are particularly susceptible to the onset of iron deficiency anemia (Daily & Wylie, 2008). It has been estimated that 1 in 2 pregnant women will be diagnosed with iron deficiency (Scholl, 2005). During pregnancy maternal plasma volume expands, increasing iron requirements (Scholl et al., 2000) whilst dietary intakes generally remain unchanged (Milman, 2006). Physiologically, intestinal iron absorption may increase during pregnancy but only after iron depletion has already commenced (Milman, 2006). Research strongly suggests that pregnant women are not meeting dietary guidelines for iron (Derbyshire et al., 2009).
A Sheffield (UK) study has reported that pregnant women consume around 10.2mg of iron per day (Mouratidou et al., 2006). Another investigation undertaken in a London population found that expectant mothers had a mean intake of 10.7mg iron per day (Rees et al., 2005). A further study investigating the diet of educated, Caucasian pregnant mothers reported similar figures (Derbyshire et al., 2006). Diets deficient in iron during gestation may subsequently affect infant health, in both the short and longer term (Scholl & Reilly, 2000). Iron deficiencies in pregnancy have been linked to preterm deliveries, reduced infant birth weight, length and iron stores (Daily & Wylie, 2008). Low iron stores during periods of infant brain growth may permanently impede cognitive development (Lozoff, 2007 & Lozoff & Georgieff, 2006).
Teff (Eragrostis tef) is a staple food consumed in northern, western and central Ethiopia; usually in the form of Enjera (flat bread prepared using a range of cereals, including Eragrostis tef) (Umeta et al., 2005). Research has shown that Teff is a rich source of bioavailable iron which may be attributed to its low phytate content. Bread made with Tef enjera contains around 30mg of iron per 100g and up to 35mg when the food is fermented (Umeta et al., 2005). The iron content dramatically exceeds that of common Western foods (Corn flakes 7.9mg, boiled brown rice, 0.5mg and brown bread, 2.2mg, all per 100g consumed) (FSA, 2006). Furthermore, studies have shown that the prevalence of pregnancy iron deficiency anemia is relatively low in Ethiopia (Gies et al., 2003) which may be attributed to Eragrostis tef forming a staple part of the diet (Haidar et al., 1999).
Incorporation of Teff into the daily diet of expectant mothers may help to reduce the incidence of iron-deficiency anemia. Research shows that women do not adhere to taking large tablet supplements (Nguyen et al., 2008). Teff may therefore provide an alternative source of dietary iron that can be easily incorporated into the daily diet of both pregnant mothers and the lay public.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
Keywords
iron, bioavailability, status, deficiency, anaemia, functional foods, child bearing
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Control bread
Arm Title
Teff bread
Arm Type
Active Comparator
Arm Description
Teff bread
Intervention Type
Other
Intervention Name(s)
Control bread
Other Intervention Name(s)
Low-iron bread
Intervention Description
Control bread
Intervention Type
Other
Intervention Name(s)
Teff Bread
Other Intervention Name(s)
High-iron bread
Intervention Description
Teff bread
Primary Outcome Measure Information:
Title
To develop Teff bread that is rich in iron (per slice).
Time Frame
2 years
Title
To establish whether iron from Teff is bioavailable.
Time Frame
2 years
Title
To conclude whether daily Teff consumption prevents iron-deficiency anemia in pregnancy.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
To use a range of different biomarkers to determine iron status.
Time Frame
2 years
Title
To compare dietary intakes of iron and iron status between the Teff/control group.
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Caucasian
Primiparous
Singleton pregnancy (wk 20 to wk 30)
Non smokers
Pre pregnancy BMI between 19.8 and 26
Healthy, free from iron metabolism disorders (pregnancy induced hypertension
Not taking medicines known to influence iron status
Not taking iron supplements (multivitamins will be accounted for)
Free from gastrointestinal disorders
No allergies
Exclusion Criteria:
Pregnancy haemoglobin concentrations are not within the normal range (below 70g/l or over 160g/l)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Emma J Derbyshire
Organizational Affiliation
Manchester Metropolitan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manchester Food Research Centre, Manchester Metropolitan University
City
Manchester
ZIP/Postal Code
M14 6HR
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
12641613
Citation
McKenna D, Spence D, Haggan SE, McCrum E, Dornan JC, Lappin TR. A randomized trial investigating an iron-rich natural mineral water as a prophylaxis against iron deficiency in pregnancy. Clin Lab Haematol. 2003 Apr;25(2):99-103. doi: 10.1046/j.1365-2257.2003.00501.x.
Results Reference
background
Links:
URL
http://mmu.ac.uk
Description
Manchester Metropolitan University
URL
http://www.rofar.org
Description
ROCHE Foundation for Anemia Research
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A Functional Food for the Prevention of Iron-deficiency Anemia
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