Influence of Hesperidin and Vitamin C on Uric Acid Concentration

Not Applicable

Completed

• Conditions: Higher Uric Acid Concentrations (>5,5 mg/dl); Healthy
• Interventions: Dietary Supplement: Control; Dietary Supplement: Vitamin C; Dietary Supplement: Hesperidin; Dietary Supplement: Hesperidin + Vitamin C

• Registration Number: NCT04316390
• Lead Sponsor: University of Kiel

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 Timeline

• Study First Submitted: 2020-03-12
• Study First Submitted QC: 2020-03-19
• Study First Posted: 2020-03-20
• Study Start: 2022-07-15
• Primary Completion: 2023-03-22
• Study Completion: 2023-03-30
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-30
• Last Update Posted: 2023-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hesperidin (A)	Hesperidin	study drink without hesperidin and without vitamin C compared to study drink with hesperidin
Hesperidin + Vitamin C (B)	Hesperidin + Vitamin C	study drink with vitamin C compared to study drink with hesperidin and vitamin C
Hesperidin (A)	Control	study drink without hesperidin and without vitamin C compared to study drink with hesperidin
Hesperidin + Vitamin C (B)	Vitamin C	study drink with vitamin C compared to study drink with hesperidin and vitamin C

Primary Outcome Measures

Name	Time	Method
Changes in uric acid serum concentrations	Baseline (pre) and post two weeks of intervention	measured via uric acid serum concentration (mg/dL)

Secondary Outcome Measures

Name	Time	Method
changes in pulse wave velocity	Baseline (pre) and post two weeks of intervention	measured via oscillometric method (m/s)
insulin sensitivity	Baseline (pre) intervention periods	measured via minimal model from oral glucose tolerance test data using the particular study drink with added glucose to 75 g Glucose / 200 mL
changes in uric acid excretion	Baseline (pre) and post two weeks of intervention	measured via uric acid excretion in 24h urine (mg/24h)

Trial Locations

Locations (1)

Institute of Human Nutrition; 🇩🇪 Kiel, Germany