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Clinical Trials/NCT04316390
NCT04316390CompletedNot Applicable

Influence of Hesperidin and Vitamin C on Uric Acid Concentration

University of Kiel1 site in 1 country40 target enrollmentStarted: July 15, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Changes in uric acid serum concentrations

Study Overview

Brief Summary

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • •pregnancy
  • •fructose intolerance
  • •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

Arms & Interventions

Hesperidin (A)

Experimental

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

Intervention: Control (Dietary Supplement)

Hesperidin + Vitamin C (B)

Experimental

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

Intervention: Hesperidin + Vitamin C (Dietary Supplement)

Hesperidin + Vitamin C (B)

Experimental

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

Intervention: Vitamin C (Dietary Supplement)

Hesperidin (A)

Experimental

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

Intervention: Hesperidin (Dietary Supplement)

Outcomes

Primary Outcomes

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

  • changes in pulse wave velocity(Baseline (pre) and post two weeks of intervention)
  • insulin sensitivity(Baseline (pre) intervention periods)
  • changes in uric acid excretion(Baseline (pre) and post two weeks of intervention)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Prof. Dr. Dr. Anja Bosy-Westphal

Prof. Dr. Dr. Anja Bosy-Westphal

University of Kiel

Study Sites (1)

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