NCT01881919

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 20, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

March 24, 2015

Status Verified

March 1, 2015

Enrollment Period

1.2 years

First QC Date

June 7, 2013

Last Update Submit

March 20, 2015

Conditions

HyperuricemiaGoutKidney CalculiDiabetesCardiovascular Disease

Keywords

Functional Food

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Kidney excretion of uric acid: urinary uric acid level

    24 h urine samples are collected on day 14 and 28 of each arm and volume is recorded

  • Blood pressure

    Blood pressure is measured on day 1 and 29 of each arm

  • Blood glucose

    Fasted blood samples are collected on day 1, 15, 29 of each arm

  • Metabolomic and metabonomic profiling of blood plasma

    Fasting blood samples are taken on day 1, day 15 and day 29 of each arm

Other Outcomes (5)

  • Urinary excretion of quercetin

    24 h urine will be collected on day 14 and 28 of each arm and volume is recorded

  • Subject Body Weight

    weight is measured on day 1 and 29 of each arm

  • Subject Height

    Height is measured on day 1 and 29 of each arm

  • +2 more other outcomes

Study Arms (2)

Treatment

EXPERIMENTAL

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

Dietary Supplement: Treatment

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Control

Interventions

TreatmentDIETARY_SUPPLEMENT

Address: Nature's Best, Century Place, Tunbridge Wells, Kent, TN2 3BE Phone:+44(0)1892 552030 Email:info@naturesbest.co.uk

Also known as: Quercetin dihydrate 500 mg tablet, Brand: Nature's Best, Batch Number:114501, Serial Number: 5055148404901
Treatment
ControlDIETARY_SUPPLEMENT

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

Also known as: Placebo: lactose tablet, Brand: Fagron, Serial Number: PZN-0921071, Batch Number:1208D001A
Placebo

Eligibility Criteria

Age19 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent
  • Plasma Uric Acid \> 300 micro Mole/L
  • Generally Healthy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Food Science and Nutrition

Leeds, West Yorkshire, LS2 9JT, United Kingdom

Location

MeSH Terms

Conditions

HyperuricemiaGoutKidney CalculiDiabetes MellitusCardiovascular Diseases

Interventions

TherapeuticsTablets

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesNephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalGlucose Metabolism DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Officials

  • Gary Williamson, PhD

    University of Leeds

    STUDY CHAIR

  • Yuanlu Shi, PhD Candidate

    University ofLeeds

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

June 7, 2013

First Posted

June 20, 2013

Study Start

February 1, 2013

Primary Completion

April 1, 2014

Study Completion

November 1, 2014

Last Updated

March 24, 2015

Record last verified: 2015-03

Locations

GB(1)