HyperuricemiaEarly Phase 1NCT01881919
Effect of Quercetin Supplements on Healthy Males: a Four-Week Randomized Cross-Over Trial
A Early Phase 1 study testing Treatment in people with Hyperuricemia and Gout, run by University of Leeds at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 19 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperuricemia, Gout, Kidney Calculi
- What is being tested?
- Treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2013to Nov 2014
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent
- Plasma Uric Acid > 300 micro Mole/L
- Generally Healthy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
School of Food Science and Nutrition
Leeds, West Yorkshire, LS2 9JT
About this study
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
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.
Read the 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.
- Conditions
- Hyperuricemia, Gout, Kidney Calculi, Diabetes, Cardiovascular Disease
- Being tested
- Treatment, Control
- Keywords
- Functional Food
- Medical subject headings
- Hyperuricemia, Gout, Kidney Calculi, Diabetes Mellitus, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreatmentDietary supplement
Also called Quercetin dihydrate 500 mg tablet, Brand: Nature's Best, Batch Number:114501, Serial Number: 5055148404901
Address: Nature's Best, Century Place, Tunbridge Wells, Kent, TN2 3BE Phone:+44(0)1892 552030 Email:info@naturesbest.co.uk
ControlDietary supplement
Also called Placebo: lactose tablet, Brand: Fagron, Serial Number: PZN-0921071, Batch Number:1208D001A
Address: Fagron GmbH\&Co. KG, 22885 Barsbuttel, Germany Phone: +49(0)4067067680
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Daily intake of Quercetin supplement 500mg tablet for 28 days with meal (breakfast preferred.) Receives: Dietary Supplement: Treatment |
| Placebo | Placebo comparator | Daily intake of Placebo (lactose) tablet for 28 days with meal (breakfast preferred) Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Difference in 24-h urinary uric acid level at 14 days and 28 days between arms
Measured: 24 h urine samples are collected on day 14 and 28 of each arm and volume is recorded
Blood pressure
To monitor the compliance of subject.
Measured: Blood pressure is measured on day 1 and 29 of each arm
Blood glucose
The change of plasma glucose level from the baseline at day 15 and day 29 of each arm.
Measured: Fasted blood samples are collected on day 1, 15, 29 of each arm
Metabolomic and metabonomic profiling of blood plasma
1H NMR (proton nuclear magnetic resonance )
Measured: Fasting blood samples are taken on day 1, day 15 and day 29 of each arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study startFeb 2013
- Primary completionApr 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperuricemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuanlu Shi, University of Leeds
- Investigators
- Gary Williamson, PhD, Study chair, University of LeedsYuanlu Shi, PhD Candidate, Principal investigator, University ofLeeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881919
- Sponsor's protocol ID
- MEEC12-019
- Status last verified
- Mar 2015
- First submitted
- 7 Jun 2013
- Last updated
- 24 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01881919
- Acronym / sponsor ID
- MEEC12-019
- Conditions
- Hyperuricemia, Gout, Kidney Calculi, Diabetes, Cardiovascular Disease
- Keywords
- Functional Food
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 20 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Dietary Supplement: TreatmentDaily intake of Quercetin supplement 500mg tablet for 28 days with meal (breakfast preferred.) |
| Placebo | Placebo comparator | Dietary Supplement: ControlDaily intake of Placebo (lactose) tablet for 28 days with meal (breakfast preferred) |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent
- Plasma Uric Acid > 300 micro Mole/L
- Generally Healthy
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TreatmentAlso: Quercetin dihydrate 500 mg tablet, Brand: Nature's Best, Batch Number:114501, Serial Number: 5055148404901Address: Nature's Best, Century Place, Tunbridge Wells, Kent, TN2 3BE Phone:+44(0)1892 552030 Email:info@naturesbest.co.uk | Dietary supplement | Treatment |
| ControlAlso: Placebo: lactose tablet, Brand: Fagron, Serial Number: PZN-0921071, Batch Number:1208D001AAddress: Fagron GmbH\&Co. KG, 22885 Barsbuttel, Germany Phone: +49(0)4067067680 | Dietary supplement | Placebo |
Primary outcome
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.
4 secondary outcomes
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
Blood pressure
Time frame: Blood pressure is measured on day 1 and 29 of each arm
Blood glucose
Time frame: Fasted blood samples are collected on day 1, 15, 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Williamson, PhD study chair
University of Leeds
Yuanlu Shi, PhD Candidate principal investigator
University ofLeeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Treatment in people with Hyperuricemia and Gout, run by University of Leeds at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2015.