NCT04316390

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 20, 2020

Completed
2.3 years until next milestone

Study Start

First participant enrolled

July 15, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2023

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

8 months

First QC Date

March 12, 2020

Last Update Submit

June 30, 2023

Conditions

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

Keywords

hesperidinvitamin Curic acid concentration

Outcome Measures

Primary Outcomes (1)

  • Changes in uric acid serum concentrations

    measured via uric acid serum concentration (mg/dL)

    Baseline (pre) and post two weeks of intervention

Secondary Outcomes (3)

  • changes in uric acid excretion

    Baseline (pre) and post two weeks of intervention

  • changes in pulse wave velocity

    Baseline (pre) and post two weeks of intervention

  • insulin sensitivity

    Baseline (pre) intervention periods

Other Outcomes (2)

  • bioavailability of hesperidin in blood

    Baseline (pre) and post two weeks of intervention

  • bioavailability of hesperidin in urine

    Baseline (pre) and post two weeks of intervention

Study Arms (2)

Hesperidin (A)

EXPERIMENTAL

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

Dietary Supplement: ControlDietary Supplement: Hesperidin

Hesperidin + Vitamin C (B)

EXPERIMENTAL

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

Dietary Supplement: Vitamin CDietary Supplement: Hesperidin + Vitamin C

Interventions

ControlDIETARY_SUPPLEMENT

study drink (two weeks)

Hesperidin (A)
HesperidinDIETARY_SUPPLEMENT

study drink + Hesperidin 600 mg (two weeks)

Hesperidin (A)
Vitamin CDIETARY_SUPPLEMENT

study drink + Vitamin C 250 mg (two weeks)

Hesperidin + Vitamin C (B)
Hesperidin + Vitamin CDIETARY_SUPPLEMENT

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

Hesperidin + Vitamin C (B)

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Human Nutrition

Kiel, 24105, Germany

Location

MeSH Terms

Interventions

HesperidinAscorbic Acid

Intervention Hierarchy (Ancestors)

FlavanonesFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingGlycosidesCarbohydratesSugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy Acids

Study Officials

  • Anja Bosy-Westphal, Prof, PhD, MD

    Institute of Human Nutrition, Kiel University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Dr. Anja Bosy-Westphal

Study Record Dates

First Submitted

March 12, 2020

First Posted

March 20, 2020

Study Start

July 15, 2022

Primary Completion

March 22, 2023

Study Completion

March 30, 2023

Last Updated

July 3, 2023

Record last verified: 2023-06

Locations

DE(1)