Does eating mandarin oranges impact cardiometabolic risk factors and omics biomarkers in a general population intervention trial?

Not Applicable

• Conditions: Prevention of cardiovascular and metabolic diseases in subjects from the general population; Not Applicable

• Registration Number: ISRCTN14236593
• Lead Sponsor: University of Valencia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-09-25
• Last Update Posted: 30 September 2024
• Study Completion: 2025-12-19

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Volunteers recruited from the general population2. Aged 18 to 55 years old2. Body mass index (BMI) between 23 and 32 kg/m²

Exclusion Criteria

1. Do not meet the inclusion criteria.2. People allergic or intolerant to the consumption of oranges. 3. Pregnant women or breastfeeding period4. Alcoholism or drug addiction 5. Individuals presenting the following current situations: infectious diseases, renal diseases, liver diseases, cancer, obesity, type 2 diabetes, or other pathologies that may bias the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in multi-omics biomarkers (gene-expression, DNA-methylation, and plasma metabolites) from baseline to 15 days following a daily intervention with 1 kg of mandarin oranges in comparison with the control group. Gene-expression will be measured with a whole transcriptomics human array at baseline and after 15 days. DNA-methyation will be measured by a genome-wide methylation human array at baseline and after 15 days. Metabolomics will be measured in plasma by Nuclear Magnetic Resonance at baseline and after 15 days.

Secondary Outcome Measures

Name	Time	Method
1. Biochemical analysis with hematocrit, lipid profile, blood glucose, renal and hepatic function at baseline and after 15 days.2. Analysis of parameters related to oxidative stress at baseline and after 15 days.3. Measurement of blood pressure at the baseline visit and after the intervention at baseline and after 15 days.4. Weight, height, waist circumference, and body composition through baseline bioimpedance at baseline and after 15 days.5. Food intake and adherence to the Mediterranean Diet using the food consumption frequency questionnaire and the 14-point adherence questionnaire at baseline and after 15 days.6. Physical activity measured through the use of accelerometers at baseline and after 15 days.7. Characteristics of sleep measured using the Epworth Sleepiness Scale and chronotype assessed with the Morningness-Eveningness Questionnaire by Horne and Östberg at baseline and after 15 days.