- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05182138
Zinc in Potatoes Study (ZIP)
Do Zinc Fortified Potatoes Improve Zinc and Health Status?
Study Overview
Status
Conditions
Detailed Description
There is a small but critical window of dietary zinc intake from 1 to 4 mg Zn/day over which the symptoms of long-term zinc deficiency go from acute to chronic in nature. For example, at 1 mg Zn/day intake for several months, most people will develop skin lesions, but at 4 mg Zn/day, skin lesions would be very rare. However, impaired immune response can be detected when consuming zinc up to 6 mg/day over several months. Dietary intakes of <4 mg Zn/day in developed countries is rare but can be common in developing countries.
This study has been carefully designed to test the hypothesis that consumption of zinc biofortified potatoes can rescue the zinc status and health of people who are of low zinc status and consuming diets which are borderline acutely zinc deficient. The protocol for the study includes 2 weeks of zinc deprivation at around 1 mg Zn/day dietary intake (Very Low Zinc Diet) followed by 2 weeks of a borderline acutely/chronically deficient diet of around 4-5 mg Zn/day (Low Zinc Diet). Two weeks on the Very Low Zinc Diet has been carefully and deliberately selected to cause biochemical changes due to zinc deprivation but not signs and symptoms of deficiency such as skin lesions. Less than 2 weeks is insufficient to cause the biochemical effects and more that 2 weeks risks the physical manifestation of deficiency and also non-compliance by volunteers, since the diets may be less palatable than their habitual diet. Thus all volunteers will have low zinc status at the time of starting to eat the Low Zinc Diet, and the effect of eating the biofortified potatoes in addition, which will add an extra 1 mg to the daily zinc intake, should be seen in all the zinc and health status tests that the investigators are proposing. In rat studies in which the investigators did just this kind of intervention, the biofortified potato ameliorated the effect of zinc deficiency on growth, food intake and immune function.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Aberdeen, United Kingdom, AB25 2ZD
- University of Aberdeen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Males aged 18 or over
- Postmenopausal females
- Healthy
- BMI 19-35
Exclusion Criteria:
- Physical or mental health problems
- Long-term medication
- Smoking
- Alcohol >20 units/week
- Health supplements
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Unfortified potato plus placebo
Volunteers given potato with no fortified zinc and a placebo
|
Volunteers will be given 300g of zinc unfortified cooked potato as well as a placebo every day.
|
ACTIVE_COMPARATOR: Zinc Biofortified potato plus placebo
Volunteers given potato biofortified with zinc and a placebo
|
Volunteers will be given 300g of cooked potato biofortified with zinc and a placebo every day.
|
ACTIVE_COMPARATOR: Unfortified potato plus zinc supplement
Volunteers given potato with no fortified zinc and a zinc supplement
|
Volunteers will be given 300g of zinc unfortified cooked potato and a zinc supplement containing 18mg of zinc, every day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma Zinc status
Time Frame: 4 weeks
|
Plasma zinc levels will be measured using ICP-MS
|
4 weeks
|
Zinc status
Time Frame: 4 weeks
|
The Exchangeable Zinc Pool size (EZP) will be assessed by the analysis of the Zn stable isotopes excreted in the urine by ICP-MS/MS.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eye Electrophysiology
Time Frame: 4 weeks
|
After overnight dark adaptation using an eye patch, electroretinograms will be recorded following dilation with eye drops G. Tropicamide 1% & G. phenylephrine 2.5%) using non-invasive corneal electrodes.
|
4 weeks
|
Thromboelastography (efficiency of blood clotting)
Time Frame: 4 weeks
|
The efficiency of blood clotting within participants will be assessed by collecting whole blood samples into 3.2% sodium citrate tubes and then analysing this for blood clotting parameters using thromboelastography (ROTEM).
This analysis generates 4 values representing clot formation which will be assessed and compared between the different interventions: the reaction time (R), the speed of clot formation (K-value), the angle and the maximum amplitude (MA).
|
4 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: John H Beattie, PhD, University of Aberdeen
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02/033/15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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