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CompletedNCT04316390HesperiDrinCUpdated Jul 3, 2023

Influence of Hesperidin and Vitamin C on Uric Acid Concentration

An interventional study of Control and Hesperidin in Higher Uric Acid Concentrations (>5,5 mg/dl) and Healthy, sponsored by University of Kiel. Completed at 1 site in Germany. Open to participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-03.

Sponsored by University of Kiel · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Higher Uric Acid Concentrations (>5,5 mg/dl)
  • Healthy

Keywords

  • hesperidin
  • vitamin C
  • uric acid concentration
03

In context

Lead sponsor

University of Kiel is the lead sponsor of 25 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • healthy
  • higher uric acid concentration (≥5.5 mg/dL)
  • Informed written consent

Exclusion criteria

Exclusion Criteria:

  • pregnancy
  • fructose intolerance
  • smoking
  • gout or medicated hyperuricemia
  • diabetes mellitus
  • antidiabetic or cytostatic medication
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Hesperidin (A)

    study drink without hesperidin and without vitamin C compared to study drink with hesperidin

    Dietary Supplement: Control · Dietary Supplement: Hesperidin

  • Experimental
    Hesperidin + Vitamin C (B)

    study drink with vitamin C compared to study drink with hesperidin and vitamin C

    Dietary Supplement: Vitamin C · Dietary Supplement: Hesperidin + Vitamin C

Interventions

  • Dietary supplementControl

    study drink (two weeks)

  • Dietary supplementHesperidin

    study drink + Hesperidin 600 mg (two weeks)

  • Dietary supplementVitamin C

    study drink + Vitamin C 250 mg (two weeks)

  • Dietary supplementHesperidin + Vitamin C

    study drink + Hesperidin 600 mg + Vitamin C 250 mg (two weeks)

06

What researchers measure

Primary outcomes

  1. Changes in uric acid serum concentrations

    measured via uric acid serum concentration (mg/dL)

    Time frame: Baseline (pre) and post two weeks of intervention

Secondary outcomes

  1. changes in uric acid excretion

    measured via uric acid excretion in 24h urine (mg/24h)

    Time frame: Baseline (pre) and post two weeks of intervention

  2. changes in pulse wave velocity

    measured via oscillometric method (m/s)

    Time frame: Baseline (pre) and post two weeks of intervention

  3. 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

    Time frame: Baseline (pre) intervention periods

Other outcomes

  1. bioavailability of hesperidin in blood

    detection of hesperidin metabolites measured via chromatography and following mass spectrometry in serum

    Time frame: Baseline (pre) and post two weeks of intervention

  2. bioavailability of hesperidin in urine

    detection of hesperidin metabolites measured via chromatography and following mass spectrometry in 24h urine

    Time frame: Baseline (pre) and post two weeks of intervention

07

Study locations

1 site
  • Institute of Human Nutrition
    Kiel, 24105, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04316390
Lead sponsor
University of Kiel
Collaborators
Hochschule Geisenheim University
Responsible party
Prof. Dr. Dr. Anja Bosy-Westphal (Prof. Dr. Dr. Anja Bosy-Westphal, University of Kiel) — Principal investigator
First posted
Mar 20, 2020
Start date
Jul 15, 2022
Primary completion
Mar 22, 2023
Completion
Mar 30, 2023
Last update
Jul 3, 2023

Study contacts

Anja Bosy-Westphal, Prof, PhD, MD
principal investigator · Institute of Human Nutrition, Kiel University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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