Effect of Quercetin Supplements on Healthy Males: a Four-Week Randomized Cross-Over Trial
NCT ID: NCT01881919
Last Updated: 2015-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
22 participants
INTERVENTIONAL
2013-02-28
2014-11-30
Brief Summary
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Detailed Description
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Six of the volunteers will collect urine after consuming a standard meal made from fresh onion and after quercetin supplement intake, in the same way, with 3 days washout before each. The urine collected here will be analysed to check that the supplement is equivalent to the food. Stage 2 will only be conducted with supplement and placebo.
Healthy male volunteers with higher (than average) blood uric acid will be selected and will be asked to consume a standard supplement/placebo added to their own diet for 4 weeks per phase. Two arms are separated by 4 weeks resting period: quercetin supplement and placebo. Blood and urine samples will be taken every other week to detect any changes of uric acid and other biomarkers.
\----- i) Quercetin is found in a variety of foods including apples, berries, brassica vegetables, capers, grapes, onions, shallots, tea, and tomatoes, as well as many seeds, nuts, flowers, barks, and leaves.
ii) Uric acid, a compound found in both in the human body and urine, is produced by the breakdown of purines, which are nitrogen-containing compounds in substances such as nucleic acids (DNA). They enter the circulation from digestion of certain foods, drinks (alcoholic beverages like beer and wine) or from normal breakdown and turnover of cells in the body. Most uric acid is removed by the kidneys and disposed of in the urine; the remainder is excreted in the stool.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Treatment
Daily intake of Quercetin supplement 500mg tablet for 28 days with meal (breakfast preferred.)
Treatment
Address: Nature's Best, Century Place, Tunbridge Wells, Kent, TN2 3BE Phone:+44(0)1892 552030 Email:[email protected]
Placebo
Daily intake of Placebo (lactose) tablet for 28 days with meal (breakfast preferred)
Control
Address: Fagron GmbH\&Co. KG, 22885 Barsbuttel, Germany Phone: +49(0)4067067680
Interventions
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Treatment
Address: Nature's Best, Century Place, Tunbridge Wells, Kent, TN2 3BE Phone:+44(0)1892 552030 Email:[email protected]
Control
Address: Fagron GmbH\&Co. KG, 22885 Barsbuttel, Germany Phone: +49(0)4067067680
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Plasma Uric Acid \> 300 micro Mole/L
* Generally Healthy
Exclusion Criteria
* Unable or unwilling to comply with the protocol, or likely to leave the study before its completion.
* Who would undertake important change in physical exercise or vigorous sport competitions during the study period.
* regularly drink more than 3 units of alcohol every day
* smokers
* have history of treated hyperuricemia, gout and/ or kidney stone
* have intestinal disorders
19 Years
65 Years
MALE
Yes
Sponsors
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University of Leeds
OTHER
Responsible Party
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Yuanlu Shi
PhD Candidate
Principal Investigators
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Gary Williamson, PhD
Role: STUDY_CHAIR
University of Leeds
Yuanlu Shi, PhD Candidate
Role: PRINCIPAL_INVESTIGATOR
University ofLeeds
Locations
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School of Food Science and Nutrition
Leeds, West Yorkshire, United Kingdom
Countries
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Other Identifiers
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MEEC12-019
Identifier Type: -
Identifier Source: org_study_id
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