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

Diabetes Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01881919
• Other study ID #: MEEC12-019
• Status: Completed
• Phase: Phase 0
• First received: June 7, 2013
• Last updated: March 20, 2015
• Start date: February 2013
• Est. completion date: November 2014

Study information

• Verified date: March 2015
• Source: University of Leeds
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes
• Gout
• Hyperuricemia
• Kidney Calculi

Intervention

Dietary Supplement:
• Treatment
Address: Nature's Best, Century Place, Tunbridge Wells, Kent, TN2 3BE Phone:+44(0)1892 552030 Email:info@naturesbest.co.uk
• Control
Address: Fagron GmbH&Co. KG, 22885 Barsbuttel, Germany Phone: +49(0)4067067680

Locations

Country	Name	City	State
United Kingdom	School of Food Science and Nutrition	Leeds	West Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Leeds

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	Subject Body Weight	To monitor the compliance of subject.	weight is measured on day 1 and 29 of each arm	No
Other	Subject Height	To monitor the compliance of subject.	Height is measured on day 1 and 29 of each arm	No
Other	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.	No
Other	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	No
Primary	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	No
Secondary	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	No
Secondary	Blood pressure	To monitor the compliance of subject.	Blood pressure is measured on day 1 and 29 of each arm	No
Secondary	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	No
Secondary	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	No

External Links

•   Information Sheet for Volunteers
•   Registration System