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

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ClinicalTrials.gov Identifier: NCT01881919
Recruitment Status : Completed
First Posted : June 20, 2013
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):
Yuanlu Shi, University of Leeds

Tracking Information
First Submitted Date  ICMJE June 7, 2013
First Posted Date  ICMJE June 20, 2013
Last Update Posted Date March 24, 2015
Study Start Date  ICMJE February 2013
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 17, 2013)
Risk of getting hyperuricemia assessed by the measure of plasma uric acid. [ Time Frame: Fasted 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.
Change History Complete list of historical versions of study NCT01881919 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2015)
  • 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
  • Blood pressure [ Time Frame: Blood pressure is measured on day 1 and 29 of each arm ]
    To monitor the compliance of subject.
  • 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.
  • 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 )
Original Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2013)
  • 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
  • Blood pressure [ Time Frame: Blood pressure is measured on day 1 and 29 of each arm ]
    To monitor the compliance of subject.
  • 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.
Current Other Pre-specified Outcome Measures
 (submitted: June 17, 2013)
  • 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.
  • Subject Body Weight [ Time Frame: weight is measured on day 1 and 29 of each arm ]
    To monitor the compliance of subject.
  • Subject Height [ Time Frame: Height is measured on day 1 and 29 of each arm ]
    To monitor the compliance of subject.
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effect of Quercetin Supplements on Healthy Males: a Four-Week Randomized Cross-Over Trial
Official Title  ICMJE A Double-Blind, Cross-Over, Placebo-Controlled Study Evaluating the Effect of Quercetin 500 mg Tablets on Blood Uric Acid in Healthy Males
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE
  • Hyperuricemia
  • Gout
  • Kidney Calculi
  • Diabetes
  • Cardiovascular Disease
Intervention  ICMJE
  • Dietary Supplement: Treatment
    Address: Nature's Best, Century Place, Tunbridge Wells, Kent, TN2 3BE Phone:+44(0)1892 552030 Email:info@naturesbest.co.uk
    Other Names:
    • Quercetin dihydrate 500 mg tablet
    • Brand: Nature's Best
    • Batch Number:114501
    • Serial Number: 5055148404901
  • Dietary Supplement: Control
    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
Study Arms  ICMJE
  • Experimental: Treatment
    Daily intake of Quercetin supplement 500mg tablet for 28 days with meal (breakfast preferred.)
    Intervention: Dietary Supplement: Treatment
  • Placebo Comparator: Placebo
    Daily intake of Placebo (lactose) tablet for 28 days with meal (breakfast preferred)
    Intervention: Dietary Supplement: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 20, 2015)
22
Original Estimated Enrollment  ICMJE
 (submitted: June 17, 2013)
50
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 19 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01881919
Other Study ID Numbers  ICMJE MEEC12-019
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yuanlu Shi, University of Leeds
Study Sponsor  ICMJE University of Leeds
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Gary Williamson, PhD University of Leeds
Principal Investigator: Yuanlu Shi, PhD Candidate University ofLeeds
PRS Account University of Leeds
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP