Influence of Hesperidin and Vitamin C on Uric Acid Concentration

Healthy Clinical Trial

— HesperiDrinC  

Official title:

Influence of Hesperidin and Vitamin C on Uric Acid Concentration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04316390
• Other study ID #: ABW-2020-OS2
• Status: Completed
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: March 30, 2023

Study information

• Verified date: June 2023
• Source: University of Kiel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 30, 2023
• Est. primary completion date: March 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• Control
study drink (two weeks)
• Hesperidin
study drink + Hesperidin 600 mg (two weeks)
• Vitamin C
study drink + Vitamin C 250 mg (two weeks)
• Hesperidin + Vitamin C
study drink + Hesperidin 600 mg + Vitamin C 250 mg (two weeks)

Locations

Country	Name	City	State
Germany	Institute of Human Nutrition	Kiel

Sponsors (2)

Lead Sponsor	Collaborator
University of Kiel	Hochschule Geisenheim University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	Changes in uric acid serum concentrations	measured via uric acid serum concentration (mg/dL)	Baseline (pre) and post two weeks of intervention
Secondary	changes in uric acid excretion	measured via uric acid excretion in 24h urine (mg/24h)	Baseline (pre) and post two weeks of intervention
Secondary	changes in pulse wave velocity	measured via oscillometric method (m/s)	Baseline (pre) and post two weeks of intervention
Secondary	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