School of Food Science and Nutrition
Leeds, West Yorkshire, LS2 9JT, United Kingdom
NCT Number: NCT01881919
The purpose of this study was to test the effect of chronic consumption of Quercetin 500 mg tablets on blood uric acid and other biomarkers in adult males.
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Notify Me19 year–65 year
Male
Interventional
Early Phase 1
Leeds, West Yorkshire, LS2 9JT, United Kingdom
The main goal of the research is to determine the long term effects of daily supplementation of quercetin, a compound naturally and normally present in food, on the chemical composition (uric acid ii and glucose) of blood and urine and on blood pressure, of healthy males.
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Address: Nature's Best, Century Place, Tunbridge Wells, Kent, TN2 3BE Phone:+44(0)1892 552030 Email:[email protected]
Other names: Quercetin dihydrate 500 mg tablet, Brand: Nature's Best, Batch Number:114501, Serial Number: 5055148404901
Address: Fagron GmbH&Co. KG, 22885 Barsbuttel, Germany Phone: +49(0)4067067680
Other names: Placebo: lactose tablet, Brand: Fagron, Serial Number: PZN-0921071, Batch Number:1208D001A
Time frame: Fasting blood samples are taken on day 1, day 15 and day 29 of each arm
The change of plasma uric acid level from day 1 on day 15 and day 29 of each arm.
Time frame: 24 h urine samples are collected on day 14 and 28 of each arm and volume is recorded
Difference in 24-h urinary uric acid level at 14 days and 28 days between arms
Time frame: Blood pressure is measured on day 1 and 29 of each arm
To monitor the compliance of subject.
Time frame: Fasted blood samples are collected on day 1, 15, 29 of each arm
The change of plasma glucose level from the baseline at day 15 and day 29 of each arm.
Time frame: Fasting blood samples are taken on day 1, day 15 and day 29 of each arm
1H NMR (proton nuclear magnetic resonance )
Time frame: 24 h urine will be collected on day 14 and 28 of each arm and volume is recorded
To monitor the compliance of subject.
Time frame: weight is measured on day 1 and 29 of each arm
To monitor the compliance of subject.
Time frame: Height is measured on day 1 and 29 of each arm
To monitor the compliance of subject.
Time frame: Recall Questionnaires about the past 28 days are required on day 1 and 29 of each arm.
To monitor the compliance of subject.
Time frame: Recall Questionnaires about history of certain disease, routine medication / supplements, allergies and exercise/diet practice at enrollment
To set baseline for maintaining lifestyle and routine medicine for the study.
University of Leeds
Other
A Double-Blind, Cross-Over, Placebo-Controlled Study Evaluating the Effect of Quercetin 500 mg Tablets on Blood Uric Acid in Healthy Males
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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