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

NCT ID: NCT01881919

Last Updated: 2015-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hyperuricemia Gout Kidney Calculi Diabetes Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Treatment

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

Group Type EXPERIMENTAL

Treatment

Intervention Type DIETARY_SUPPLEMENT

Address: Nature's Best, Century Place, Tunbridge Wells, Kent, TN2 3BE Phone:+44(0)1892 552030 Email:[email protected]

Placebo

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

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DIETARY_SUPPLEMENT

Address: Fagron GmbH\&Co. KG, 22885 Barsbuttel, Germany Phone: +49(0)4067067680

Interventions

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Treatment

Address: Nature's Best, Century Place, Tunbridge Wells, Kent, TN2 3BE Phone:+44(0)1892 552030 Email:[email protected]

Intervention Type DIETARY_SUPPLEMENT

Control

Address: Fagron GmbH\&Co. KG, 22885 Barsbuttel, Germany Phone: +49(0)4067067680

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Quercetin dihydrate 500 mg tablet Brand: Nature's Best Batch Number:114501 Serial Number: 5055148404901 Placebo: lactose tablet Brand: Fagron Serial Number: PZN-0921071 Batch Number:1208D001A

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Leeds

OTHER

Sponsor Role lead

Responsible Party

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Yuanlu Shi

PhD Candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gary Williamson, PhD

Role: STUDY_CHAIR

University of Leeds

Yuanlu Shi, PhD Candidate

Role: PRINCIPAL_INVESTIGATOR

University ofLeeds

Locations

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School of Food Science and Nutrition

Leeds, West Yorkshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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MEEC12-019

Identifier Type: -

Identifier Source: org_study_id

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