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Completed

NCT Number: NCT01881919

Effect of Quercetin Supplements on Healthy Males: a Four-Week Randomized Cross-Over Trial

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent
  • Plasma Uric Acid > 300 micro Mole/L
  • Generally Healthy

Exclusion criteria

  • Body Mass Index (BMI) ≥ 30 kg/m² or <18.5 kg/m²
  • 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

Treatment and study plan

Treatment

Dietary Supplement

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

Control

Dietary Supplement

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

Primary outcomes

  1. Risk of getting hyperuricemia assessed by the measure of plasma uric acid.

    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.

Secondary outcomes

  1. Kidney excretion of uric acid: urinary uric acid level

    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

  2. Blood pressure

    Time frame: Blood pressure is measured on day 1 and 29 of each arm

    To monitor the compliance of subject.

  3. Blood glucose

    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.

  4. Metabolomic and metabonomic profiling of blood plasma

    Time frame: Fasting blood samples are taken on day 1, day 15 and day 29 of each arm

    1H NMR (proton nuclear magnetic resonance )

Other outcomes

  1. Urinary excretion of quercetin

    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.

  2. Subject Body Weight

    Time frame: weight is measured on day 1 and 29 of each arm

    To monitor the compliance of subject.

  3. Subject Height

    Time frame: Height is measured on day 1 and 29 of each arm

    To monitor the compliance of subject.

  4. Life style maintenance

    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.

  5. Primary health assessment

    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.

Sponsors and collaborators

Lead sponsor

University of Leeds

Other

Registry information

Official study title

A Double-Blind, Cross-Over, Placebo-Controlled Study Evaluating the Effect of Quercetin 500 mg Tablets on Blood Uric Acid in Healthy Males

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 20, 2013
Registry last updated
Mar 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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