Influence of Hesperidin and Vitamin C on Uric Acid Concentration (HesperiDrinC)

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

Study Overview

• Status: Completed
• Conditions: Healthy; Higher Uric Acid Concentrations (>5,5 mg/dl)
• Intervention / Treatment: Dietary supplement: Control; Dietary supplement: Hesperidin; Dietary supplement: Vitamin C; Dietary supplement: Hesperidin + Vitamin C

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anja Bosy-Westphal, Prof, PhD, MD; Phone Number: +494318805674; Email: abosyw@nutrition.uni-kiel.de

Study Locations

• Germany
  • Kiel, Germany, 24105
    • Institute of Human Nutrition

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hesperidin (A); study drink without hesperidin and without vitamin C compared to study drink with hesperidin	Dietary supplement: Control; study drink (two weeks); Dietary supplement: Hesperidin; study drink + Hesperidin 600 mg (two weeks)
Experimental: Hesperidin + Vitamin C (B); study drink with vitamin C compared to study drink with hesperidin and vitamin C	Dietary supplement: Vitamin C; study drink + Vitamin C 250 mg (two weeks); Dietary supplement: Hesperidin + Vitamin C; study drink + Hesperidin 600 mg + Vitamin C 250 mg (two weeks)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in uric acid serum concentrations	measured via uric acid serum concentration (mg/dL)	Baseline (pre) and post two weeks of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in uric acid excretion	measured via uric acid excretion in 24h urine (mg/24h)	Baseline (pre) and post two weeks of intervention
changes in pulse wave velocity	measured via oscillometric method (m/s)	Baseline (pre) and post two weeks of intervention
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	Baseline (pre) intervention periods

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
bioavailability of hesperidin in blood	detection of hesperidin metabolites measured via chromatography and following mass spectrometry in serum	Baseline (pre) and post two weeks of intervention
bioavailability of hesperidin in urine	detection of hesperidin metabolites measured via chromatography and following mass spectrometry in 24h urine	Baseline (pre) and post two weeks of intervention

Collaborators and Investigators

• Sponsor: University of Kiel
• Collaborators: Hochschule Geisenheim University
• Investigators: Principal Investigator: Anja Bosy-Westphal, Prof, PhD, MD, Institute of Human Nutrition, Kiel University

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Actual): March 22, 2023
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: March 12, 2020
• First Submitted That Met QC Criteria: March 19, 2020
• First Posted (Actual): March 20, 2020

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 30, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: vitamin C; hesperidin; uric acid concentration
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Antioxidants; Vitamins; Ascorbic Acid
• Other Study ID Numbers: ABW-2020-OS2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No