Plain English Summary
Background and study aims
Dietary zinc is important for human growth, development and immunity. Minor zinc deficiency is common but difficult to assess. While blood plasma zinc has been successfully used to assess how people respond to zinc supplementation, it is a weak indicator for individual zinc status. In the UK, a lot of young women are not getting the enough zinc through their diet. Unlike many other minerals, the body has no stores of zinc to use when intakes are low. Research has shown that zinc-responsive genes can monitor zinc status. The aim of this study is to assess both the dietary intake of zinc and indicators in the body of zinc status in vegetarian and non-vegetarian women before and after supplementation.
Who can participate?
Women living in the UK aged 19-45
What does the study involve?
The study looks at two dietary groups of women: vegetarian and non-vegetarian. Within their dietary groups, women are randomly allocated to receive either zinc or placebo (dummy). For each visit participants come in without having eaten or drunk anything apart from water and are asked not to brush their teeth. A trained doctor takes two blood samples at the start of the study and on the 7th and 14th days of the study. In addition, participants provide a saliva sample at each visit for further analysis. They are given a food frequency questionnaire to complete on your first visit, and are asked to recall what they ate the day before attending the clinic at each visit.
What are the possible benefits and risks of taking part?
Participants receive information about their current zinc status and when they complete the study they are offered a £10 Starbucks gift voucher. Once all data has been analysed, personalised feedback is provided. There are no risks for supplementation of zinc at this level. Women in many countries have similar intakes of zinc. Participants may suffer from bruising from the blood sampling and embarrassment from giving a saliva sample.
Where is the study run from?
University of Surrey, Guildford, FHMS Clinical Investigation Unit (CIU) (UK)
When is the study starting and how long is it expected to run for?
The study started in November 2011 and recruited up until May 2012
Who is funding the study?
General Authority for Health Services for the Emirate of Abu Dhabi
Who is the main contact?
Dr J. Bernadette Moore
j.b.moore@surrey.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr J. Bernadette Moore
ORCID ID
Contact details
22 AY 03
FHMS
University of Surrey
Guildford
GU2 7XH
United Kingdom
+44 (0)1483 686405
j.b.moore@surrey.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Assessment of dietary zinc intake and molecular biomarkers of zinc status in UK women: a double-blinded randomised case-controlled study
Acronym
Study hypothesis
1. Vegetarian women will have lower intakes of dietary zinc than non-vegetarian women
2. There will be no significant difference in serum zinc levels between the two groups in response to supplementation
3. The expression of zinc transports will respond to zinc supplementation
Ethics approval
Faculty of Health and Medical Sciences (FHMS) Ethics Committee, 29/03/2011, ref: EC/2011/02
Study design
Double-blinded randomised placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet.
Condition
Zinc deficiency
Intervention
There are two dietary groups: vegetarian and non-vegetarian. There are two treatment-sub-groups:
1. 15 mg/day of zinc as zinc gluconate
2. Placebo
Total duration of intervention: 2 weeks
Route of administration: by mouth for both supplement and placebo.
Excess pills were provided and a pill count was completed after the week of supplementation in order to monitor compliance.
Intervention type
Supplement
Phase
Drug names
Primary outcome measures
1. Zinc transporter (SLC30A1 and SLC39A3) transcript levels in blood and saliva.
2. Serum concentrations of zinc by blood samples
Secondary outcome measures
Dietary intakes of zinc, phytate and other nutrients. Zinc supplementation was measured by blood and saliva.
Overall trial start date
01/05/2011
Overall trial end date
01/12/2013
Reason abandoned
Eligibility
Participant inclusion criteria
1. Healthy females
2. British residents
3. Aged between 19-45 years
Participant type
Healthy volunteer
Age group
Adult
Gender
Female
Target number of participants
30: 15 vegetarian (7 cases, 8 controls) and 15 non-vegetarian (7 cases, 8 controls) women
Participant exclusion criteria
1. Pregnant or breastfeeding now or in last 6 months
2. History of alcohol abuse
3. Current of recent (last 2 months) use of vitamin, mineral supplements
4. History of eating disorder
5. Consumption of meat, poultry or fish in the last year (for vegetarian group)
6. Recent traumas or surgery
Recruitment start date
01/05/2011
Recruitment end date
01/05/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Surrey
Guildford
GU2 7XH
United Kingdom
Sponsor information
Organisation
University of Surrey (UK)
Sponsor details
c/o Dr. J. Bernadette Moore
22 AY 03
FHMS
Guildfrod
GU2 7XH
United Kingdom
+44 (0)1483 686405
j.b.moore@surrey.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
General Authority for Health Services for the Emirate of Abu Dhabi
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary