Higher Uric Acid Concentrations (>5,5 mg/dl)HesperiDrinCNCT04316390
Influence of Hesperidin and Vitamin C on Uric Acid Concentration
A study testing Hesperidin, Vitamin C and Hesperidin + Vitamin C in people with Higher Uric Acid Concentrations (>5,5 mg/dl) and Healthy, run by University of Kiel at 1 site in Germany.
Trial summary
Aim of the study is to investigate the impact of hesperidin and/or vitamin C on elevated uric acid concentrations. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Higher Uric Acid Concentrations (>5,5 mg/dl), Healthy
- What is being tested?
- Hesperidin, Vitamin C and Hesperidin + Vitamin C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 15 Jul 2022to 30 Mar 2023
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy
- higher uric acid concentration (≥5.5 mg/dL)
- Informed written consent
Who cannot join
- pregnancy
- fructose intolerance
- smoking
- gout or medicated hyperuricemia
- diabetes mellitus
- antidiabetic or cytostatic medication
Show all 10Show fewer
- weight loss (≥5% in the past 3 months)
- consumption of vitamin C-containing supplements
- parallel participation in a clinical trial
- anemia and / or iron deficiency
Trial locations and contacts
1 site in 1 country.
About this study
Aim of the study is to investigate the impact of hesperidin and/or vitamin C on elevated uric acid concentrations.
Read the detailed description
Duration of the study is 9 weeks. 1) a washout week, 2) two intervention weeks, 3) four weeks washout period, 4) two intervention weeks.
The study is conducted under free living conditions. During washout weeks consumption of orange juice or citrus fruits or vitamin C containing supplements is restricted.
During intervention weeks 200 mL of study drink is consumed daily. And participants are asked to maintain their normal physical activity and habitual diet. Additional citrus or vitamin C containing beverages are not allowed.
At the beginning and the end of each intervention phase uric acid, insulin sensitivity, blood pressure, pulse wave velocity and bioavailability of hesperidin are assessed.
- Being tested
- Control, Hesperidin, Vitamin C, Hesperidin + Vitamin C
- Keywords
- hesperidin, vitamin C, uric acid concentration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlDietary supplement
study drink (two weeks)
HesperidinDietary supplement
study drink + Hesperidin 600 mg (two weeks)
Vitamin CDietary supplement
study drink + Vitamin C 250 mg (two weeks)
Hesperidin + Vitamin CDietary supplement
study drink + Hesperidin 600 mg + Vitamin C 250 mg (two weeks)
| Study group | Role | What they receive |
|---|---|---|
| Hesperidin (A) | Experimental | study drink without hesperidin and without vitamin C compared to study drink with hesperidin Receives: Dietary Supplement: Control; Dietary Supplement: Hesperidin |
| Hesperidin + Vitamin C (B) | Experimental | study drink with vitamin C compared to study drink with hesperidin and vitamin C Receives: Dietary Supplement: Vitamin C; Dietary Supplement: Hesperidin + Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in uric acid serum concentrations
measured via uric acid serum concentration (mg/dL)
Measured: Baseline (pre) and post two weeks of intervention
Secondary outcomes (3)
changes in uric acid excretion
measured via uric acid excretion in 24h urine (mg/24h)
Measured: Baseline (pre) and post two weeks of intervention
changes in pulse wave velocity
measured via oscillometric method (m/s)
Measured: Baseline (pre) and post two weeks of intervention
insulin sensitivity
measured via minimal model from oral glucose tolerance test data using the particular study drink with added glucose to 75 g Glucose / 200 mL
Measured: Baseline (pre) intervention periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start15 Jul 2022
- Primary completion22 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Higher Uric Acid Concentrations (>5,5 mg/dl)Studies 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kiel
- Sponsor type
- University, hospital or other
- Collaborators
- Hochschule Geisenheim University
- Responsible party
- Principal investigator, Prof. Dr. Dr. Anja Bosy-Westphal, University of Kiel
- Investigators
- Anja Bosy-Westphal, Prof, PhD, MD, Principal investigator, Institute of Human Nutrition, Kiel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04316390
- Sponsor's protocol ID
- ABW-2020-OS2
- Acronym
- HesperiDrinC
- Status last verified
- Jun 2023
- First submitted
- 12 Mar 2020
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Enderle J, Dorner R, Tondar D, Hasler M, Gilcher C, Steingass CB, Schweiggert R, Muller MJ, Bosy-Westphal A. Effect of vitamin C and hesperidin on serum uric acid concentrations in healthy adults with high uric acid levels: the randomized controlled 'HesperidrinC trial'. Eur J Nutr. 2026 Feb 25;65(2):67. doi: 10.1007/s00394-026-03905-z.
PubMed 41739218
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Hesperidin and Vitamin C on Uric Acid Concentration
- ClinicalTrials.gov ID
- NCT04316390
- Acronym / sponsor ID
- HesperiDrinC / ABW-2020-OS2
- Keywords
- hesperidin, vitamin C, uric acid concentration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of KielUniversity, hospital or other
- Collaborators
- Hochschule Geisenheim University
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 22 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 20 Mar 2020 (actual)
- 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.
Aim of the study is to investigate the impact of hesperidin and/or vitamin C on elevated uric acid concentrations.
Detailed description
Duration of the study is 9 weeks. 1) a washout week, 2) two intervention weeks, 3) four weeks washout period, 4) two intervention weeks.
The study is conducted under free living conditions. During washout weeks consumption of orange juice or citrus fruits or vitamin C containing supplements is restricted.
During intervention weeks 200 mL of study drink is consumed daily. And participants are asked to maintain their normal physical activity and habitual diet. Additional citrus or vitamin C containing beverages are not allowed.
At the beginning and the end of each intervention phase uric acid, insulin sensitivity, blood pressure, pulse wave velocity and bioavailability of hesperidin are assessed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hesperidin (A) | Experimental | Dietary Supplement: Control, Dietary Supplement: Hesperidinstudy drink without hesperidin and without vitamin C compared to study drink with hesperidin |
| Hesperidin + Vitamin C (B) | Experimental | Dietary Supplement: Vitamin C, Dietary Supplement: Hesperidin + Vitamin Cstudy drink with vitamin C compared to study drink with hesperidin and vitamin C |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- healthy
- higher uric acid concentration (≥5.5 mg/dL)
- Informed written consent
Key exclusion criteria (10 listed)
- pregnancy
- fructose intolerance
- smoking
- gout or medicated hyperuricemia
- diabetes mellitus
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 |
|---|---|---|
| Controlstudy drink (two weeks) | Dietary supplement | Hesperidin (A) |
| Hesperidinstudy drink + Hesperidin 600 mg (two weeks) | Dietary supplement | Hesperidin (A) |
| Vitamin Cstudy drink + Vitamin C 250 mg (two weeks) | Dietary supplement | Hesperidin + Vitamin C (B) |
| Hesperidin + Vitamin Cstudy drink + Hesperidin 600 mg + Vitamin C 250 mg (two weeks) | Dietary supplement | Hesperidin + Vitamin C (B) |
Primary outcome
Changes in uric acid serum concentrations
Time frame: Baseline (pre) and post two weeks of intervention
measured via uric acid serum concentration (mg/dL)
3 secondary outcomes
changes in uric acid excretion
Time frame: Baseline (pre) and post two weeks of intervention
changes in pulse wave velocity
Time frame: Baseline (pre) and post two weeks of intervention
insulin sensitivity
Time frame: Baseline (pre) intervention periods
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 3 Jul 2023.
- Derived from this study: PubMed 41739218Enderle J, Dorner R, Tondar D, Hasler M, Gilcher C, Steingass CB, Schweiggert R, Muller MJ, Bosy-Westphal A. Effect of vitamin C and hesperidin on serum uric acid concentrations in healthy adults with high uric acid levels: the randomized controlled 'HesperidrinC trial'. Eur J Nutr. 2026 Feb 25;65(2):67. doi: 10.1007/s00394-026-03905-z.
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.
Anja Bosy-Westphal, Prof, PhD, MD principal investigator
Institute of Human Nutrition, Kiel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hesperidin, Vitamin C and Hesperidin + Vitamin C in people with Higher Uric Acid Concentrations (>5,5 mg/dl) and Healthy, run by University of Kiel at 1 site in Germany.
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 10 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 3 Jul 2023. 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 Germany. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Changes in uric acid serum concentrations (time frame: Baseline (pre) and post two weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04316390, which also lists 1 linked publication.
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 3 Jul 2023.