Assessment of dietary zinc intake and molecular biomarkers of zinc status in UK women

ISRCTN	ISRCTN34559863
DOI	https://doi.org/10.1186/ISRCTN34559863
Secondary identifying numbers	N/A

Submission date: 08/08/2013
Registration date: 19/09/2013
Last edited: 13/12/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr J. Bernadette Moore
Scientific

22 AY 03
FHMS
University of Surrey
Guildford
GU2 7XH
United Kingdom

Phone	+44 (0)1483 686405
Email	j.b.moore@surrey.ac.uk

Study information

Study design	Double-blinded randomised placebo-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet.
Scientific title	Assessment of dietary zinc intake and molecular biomarkers of zinc status in UK women: a double-blinded randomised case-controlled study
Study objectives	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(s)	Faculty of Health and Medical Sciences (FHMS) Ethics Committee, 29/03/2011, ref: EC/2011/02
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/05/2011
Completion date	01/12/2013

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Female
Target number of participants	30: 15 vegetarian (7 cases, 8 controls) and 15 non-vegetarian (7 cases, 8 controls) women
Key inclusion criteria	1. Healthy females 2. British residents 3. Aged between 19-45 years
Key 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
Date of first enrolment	01/05/2011
Date of final enrolment	01/05/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Surrey

Guildford
GU2 7XH
United Kingdom

Sponsor information

University of Surrey (UK)
University/education

c/o Dr. J. Bernadette Moore
22 AY 03
FHMS
Guildfrod
GU2 7XH
England
United Kingdom

Phone	+44 (0)1483 686405
Email	j.b.moore@surrey.ac.uk
"ROR"	https://ror.org/00ks66431

Funders

Funder type

Government

General Authority for Health Services for the Emirate of Abu Dhabi

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

13/12/2017: No publications found, verifying study status with principal investigator.