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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Daily intake of Quercetin supplement 500mg tablet for 28 days with meal (breakfast preferred.) |
|
| Placebo | Placebo Comparator | Daily intake of Placebo (lactose) tablet for 28 days with meal (breakfast preferred) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment | Dietary Supplement | Address: Nature's Best, Century Place, Tunbridge Wells, Kent, TN2 3BE Phone:+44(0)1892 552030 Email:info@naturesbest.co.uk |
|
| Measure | Description | Time Frame |
|---|---|---|
| Risk of getting hyperuricemia assessed by the measure of plasma uric acid. | The change of plasma uric acid level from day 1 on day 15 and day 29 of each arm. | Fasting blood samples are taken on day 1, day 15 and day 29 of each arm |
| Measure | Description | Time Frame |
|---|---|---|
| Kidney excretion of uric acid: urinary uric acid level | Difference in 24-h urinary uric acid level at 14 days and 28 days between arms | 24 h urine samples are collected on day 14 and 28 of each arm and volume is recorded |
| Blood pressure |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary excretion of quercetin | To monitor the compliance of subject. | 24 h urine will be collected on day 14 and 28 of each arm and volume is recorded |
| Subject Body Weight | To monitor the compliance of subject. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary Williamson, PhD | University of Leeds | Study Chair |
| Yuanlu Shi, PhD Candidate | University ofLeeds | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Food Science and Nutrition | Leeds | West Yorkshire | LS2 9JT | United Kingdom |
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| ID | Term |
|---|---|
| D033461 | Hyperuricemia |
| D006073 | Gout |
| D007669 | Kidney Calculi |
| D003920 | Diabetes Mellitus |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Control | Dietary Supplement | Address: Fagron GmbH&Co. KG, 22885 Barsbuttel, Germany Phone: +49(0)4067067680 |
|
|
To monitor the compliance of subject.
| Blood pressure is measured on day 1 and 29 of each arm |
| Blood glucose | The change of plasma glucose level from the baseline at day 15 and day 29 of each arm. | Fasted blood samples are collected on day 1, 15, 29 of each arm |
| Metabolomic and metabonomic profiling of blood plasma | 1H NMR (proton nuclear magnetic resonance ) | Fasting blood samples are taken on day 1, day 15 and day 29 of each arm |
| weight is measured on day 1 and 29 of each arm |
| Subject Height | To monitor the compliance of subject. | Height is measured on day 1 and 29 of each arm |
| Life style maintenance | To monitor the compliance of subject. | Recall Questionnaires about the past 28 days are required on day 1 and 29 of each arm. |
| Primary health assessment | To set baseline for maintaining lifestyle and routine medicine for the study. | Recall Questionnaires about history of certain disease, routine medication / supplements, allergies and exercise/diet practice at enrollment |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
| D012216 | Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |