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

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

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.

Condition or disease	Intervention/treatment	Phase
Hyperuricemia; Gout; Kidney Calculi; Diabetes; Cardiovascular Disease	Dietary Supplement: Treatment; Dietary Supplement: Control	Early Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• 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 Start Date: February 2013
• Actual Primary Completion Date: April 2014
• Actual Study Completion Date: November 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment; Daily intake of Quercetin supplement 500mg tablet for 28 days with meal (breakfast preferred.)	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
Placebo Comparator: Placebo; Daily intake of Placebo (lactose) tablet for 28 days with meal (breakfast preferred)	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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 Outcome Measures:

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.

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United Kingdom

School of Food Science and Nutrition

Leeds, West Yorkshire, United Kingdom, LS2 9JT

Sponsors and Collaborators

University of Leeds

Investigators

• Study Chair: Gary Williamson, PhD; University of Leeds
• Principal Investigator: Yuanlu Shi, PhD Candidate; University ofLeeds

More Information

Additional Information:

Information Sheet for Volunteers 

• Responsible Party: Yuanlu Shi, PhD Candidate, University of Leeds
• ClinicalTrials.gov Identifier: NCT01881919
• Other Study ID Numbers: MEEC12-019
• First Posted: June 20, 2013
• Last Update Posted: March 24, 2015
• Last Verified: March 2015

Keywords provided by Yuanlu Shi, University of Leeds:

Functional Food

Additional relevant MeSH terms:

Quercetin; Kidney Calculi; Nephrolithiasis; Cardiovascular Diseases; Calculi; Hyperuricemia; Pathological Conditions, Anatomical; Pathologic Processes; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents; Physiological Effects of Drugs