Influence of Hesperidin and Vitamin C on Uric Acid Concentration

NCT ID: NCT04316390

Last Updated: 2023-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-15
• Study Completion Date: 2023-03-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Hesperidin (A)

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

Group Type: EXPERIMENTAL

Control

Intervention Type: DIETARY_SUPPLEMENT

study drink (two weeks)

Hesperidin

Intervention Type: DIETARY_SUPPLEMENT

study drink + Hesperidin 600 mg (two weeks)

Hesperidin + Vitamin C (B)

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

Group Type: EXPERIMENTAL

Vitamin C

Intervention Type: DIETARY_SUPPLEMENT

study drink + Vitamin C 250 mg (two weeks)

Hesperidin + Vitamin C

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Control

study drink (two weeks)

Intervention Type: DIETARY_SUPPLEMENT

Hesperidin

study drink + Hesperidin 600 mg (two weeks)

Intervention Type: DIETARY_SUPPLEMENT

Vitamin C

study drink + Vitamin C 250 mg (two weeks)

Intervention Type: DIETARY_SUPPLEMENT

Hesperidin + Vitamin C

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hochschule Geisenheim University

UNKNOWN

Sponsor Role: collaborator

University of Kiel

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Dr. Anja Bosy-Westphal

Prof. Dr. Dr. Anja Bosy-Westphal

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anja Bosy-Westphal, Prof, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Human Nutrition, Kiel University

Locations

Institute of Human Nutrition

Kiel, , Germany

Countries

Germany

Other Identifiers

ABW-2020-OS2

Identifier Type: -

Identifier Source: org_study_id