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

Primary Purpose

Hyperuricemia, Gout, Kidney Calculi

Status
Completed
Phase
Early Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Treatment
Control
Sponsored by
University of Leeds
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hyperuricemia focused on measuring Functional Food

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • School of Food Science and Nutrition

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment

Placebo

Arm Description

Daily intake of Quercetin supplement 500mg tablet for 28 days with meal (breakfast preferred.)

Daily intake of Placebo (lactose) tablet for 28 days with meal (breakfast preferred)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Blood pressure
To monitor the compliance of subject.
Blood glucose
The change of plasma glucose level from the baseline at day 15 and day 29 of each arm.
Metabolomic and metabonomic profiling of blood plasma
1H NMR (proton nuclear magnetic resonance )

Full Information

First Posted
June 7, 2013
Last Updated
March 20, 2015
Sponsor
University of Leeds
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1. Study Identification

Unique Protocol Identification Number
NCT01881919
Brief Title
Effect of Quercetin Supplements on Healthy Males: a Four-Week Randomized Cross-Over Trial
Official Title
A Double-Blind, Cross-Over, Placebo-Controlled Study Evaluating the Effect of Quercetin 500 mg Tablets on Blood Uric Acid in Healthy Males
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leeds

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperuricemia, Gout, Kidney Calculi, Diabetes, Cardiovascular Disease
Keywords
Functional Food

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Daily intake of Quercetin supplement 500mg tablet for 28 days with meal (breakfast preferred.)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Daily intake of Placebo (lactose) tablet for 28 days with meal (breakfast preferred)
Intervention Type
Dietary Supplement
Intervention Name(s)
Treatment
Other Intervention Name(s)
Quercetin dihydrate 500 mg tablet, Brand: Nature's Best, Batch Number:114501, Serial Number: 5055148404901
Intervention Description
Address: Nature's Best, Century Place, Tunbridge Wells, Kent, TN2 3BE Phone:+44(0)1892 552030 Email:info@naturesbest.co.uk
Intervention Type
Dietary Supplement
Intervention Name(s)
Control
Other Intervention Name(s)
Placebo: lactose tablet, Brand: Fagron, Serial Number: PZN-0921071, Batch Number:1208D001A
Intervention Description
Address: Fagron GmbH&Co. KG, 22885 Barsbuttel, Germany Phone: +49(0)4067067680
Primary Outcome Measure Information:
Title
Risk of getting hyperuricemia assessed by the measure of plasma uric acid.
Description
The change of plasma uric acid level from day 1 on 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
Secondary Outcome Measure Information:
Title
Kidney excretion of uric acid: urinary uric acid level
Description
Difference in 24-h urinary uric acid level at 14 days and 28 days between arms
Time Frame
24 h urine samples are collected on day 14 and 28 of each arm and volume is recorded
Title
Blood pressure
Description
To monitor the compliance of subject.
Time Frame
Blood pressure is measured on day 1 and 29 of each arm
Title
Blood glucose
Description
The change of plasma glucose level from the baseline at day 15 and day 29 of each arm.
Time Frame
Fasted blood samples are collected on day 1, 15, 29 of each arm
Title
Metabolomic and metabonomic profiling of blood plasma
Description
1H NMR (proton nuclear magnetic resonance )
Time Frame
Fasting blood samples are taken on day 1, day 15 and day 29 of each arm
Other Pre-specified Outcome Measures:
Title
Urinary excretion of quercetin
Description
To monitor the compliance of subject.
Time Frame
24 h urine will be collected on day 14 and 28 of each arm and volume is recorded
Title
Subject Body Weight
Description
To monitor the compliance of subject.
Time Frame
weight is measured on day 1 and 29 of each arm
Title
Subject Height
Description
To monitor the compliance of subject.
Time Frame
Height is measured on day 1 and 29 of each arm
Title
Life style maintenance
Description
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.
Title
Primary health assessment
Description
To set baseline for maintaining lifestyle and routine medicine for the study.
Time Frame
Recall Questionnaires about history of certain disease, routine medication / supplements, allergies and exercise/diet practice at enrollment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Williamson, PhD
Organizational Affiliation
University of Leeds
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yuanlu Shi, PhD Candidate
Organizational Affiliation
University ofLeeds
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Food Science and Nutrition
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS2 9JT
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.leeds.ac.uk/comms/for_staff/Onion_and_health.pdf
Description
Information Sheet for Volunteers

Learn more about this trial

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

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