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Completed

NCT Number: NCT04316390

Influence of Hesperidin and Vitamin C on Uric Acid Concentration

Aim of the study is to investigate the impact of hesperidin and/or vitamin C on elevated uric acid concentrations.

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Key information

Conditions

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

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Human Nutrition

Kiel, 24105, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Control

Dietary Supplement

study drink (two weeks)

Hesperidin

Dietary Supplement

study drink + Hesperidin 600 mg (two weeks)

Vitamin C

Dietary Supplement

study drink + Vitamin C 250 mg (two weeks)

Hesperidin + Vitamin C

Dietary Supplement

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

Primary outcomes

  1. Changes in uric acid serum concentrations

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

    measured via uric acid serum concentration (mg/dL)

Secondary outcomes

  1. changes in uric acid excretion

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

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

  2. changes in pulse wave velocity

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

    measured via oscillometric method (m/s)

  3. insulin sensitivity

    Time frame: Baseline (pre) intervention periods

    measured via minimal model from oral glucose tolerance test data using the particular study drink with added glucose to 75 g Glucose / 200 mL

Other outcomes

  1. bioavailability of hesperidin in blood

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

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

  2. bioavailability of hesperidin in urine

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

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

Sponsors and collaborators

Lead sponsor

University of Kiel

Other

Collaborators

  • Hochschule Geisenheim University

Registry information

Acronym: HesperiDrinC

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 20, 2020
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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