Evaluation of the Antioxidant and Anti-Inflammatory Capacities of the 'Rosy Red Valencia' and 'Olinda Valencia' Sweet Orange Varieties in Healthy Subjects

NCT06944210 | Completed

• 1 other identifier: 22923441
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the antioxidant and anti-inflammatory effects of acute and chronic consumption of two sweet orange (Citrus sinensis) varieties-'Rosy Red Valencia', which is rich in carotenoids such as lycopene, phytoene, and phytofluene, and 'Olinda Valencia', which lacks these carotenoids-in healthy adults. In this 4-week, randomized, parallel-arm clinical trial, participants will consume either 'Rosy Red Valencia' or 'Olinda Valencia' oranges daily. The study will assess the effects of sweet orange intake on markers of oxidative stress and inflammation, plasma carotenoid concentrations, gene expression in peripheral blood mononuclear cells, and gut health. Findings from this study may help identify potential health benefits associated with specific carotenoid profiles in sweet oranges and provide insights into their role in modulating inflammation and oxidative stress.

Conditions

Healthy

Keywords

Oranges; Lycopene; Healthy; Oxidative stress; Inflammation; gene expression

Outcome Measures

Primary Outcomes (1)

• Levels of lycopene and noncolored carotenoids

  Levels in plasma

  0, 1 day, 4 weeks

Secondary Outcomes (6)

• Oxidative stress

  0, 1 day, 4 weeks

• Inflammation

  0, 1 day, 4 weeks

• Gene expression

  0, 1 day, 4 weeks

• Microbiota composition

  0, 4 weeks

• Lipid/metabolic profile

  0, 4 weeks

Study Arms (2)

'Rosy Red Valencia' sweet orange variety

EXPERIMENTAL

The participants of this group consume 'Rosy Red Valencia' sweet oranges

Other: 'Rosy Red Valencia' sweet orange

'Olinda Valencia' sweet orange variety

EXPERIMENTAL

The participants of this group consume 'Olinda Valencia' sweet oranges

Other: 'Olinda Valencia' sweet oranges

Interventions

'Rosy Red Valencia' sweet orange OTHER

The participants consume 2 'Rosy Red Valencia' sweet oranges daily for 4 weeks

'Rosy Red Valencia' sweet orange variety

'Olinda Valencia' sweet oranges OTHER

The participants consume 2 'Olinda Valencia' sweet oranges daily for 4 weeks

'Olinda Valencia' sweet orange variety

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy men and women
• Age Range: 25-40 years
• Body mass index (BMI) with values between 21 and 29.9 kg\^m2
• Willingness to accept randomization, undergo the testing and intervention procedures, and deliver blood and stool samples
• Willingness to refrain from consuming foods rich in lycopene, phytoene, and phytofluene and limit the intake of some polyphenol-rich foods
• Willingness to discontinue the use of antioxidant supplements (such as carotenoid, polyphenol supplements), prebiotics and/or probiotics

You may not qualify if:

• Pregnancy/lactation
• History of cardiovascular diseases, diabetes, uncontrolled hypertension, heart failure, stroke, liver, gallbladder, kidney, thyroid disease, gastrointestinal, autoimmune disorder, or cancer.
• Psychiatric disease that interferes with the understanding and implementation of the intervention
• History of eating disorders (such as bulimia nervosa and anorexia nervosa) in the last 5 years
• Current smokers
• Vegan, vegetarian, or other special diets (e.g., keto, paleo)
• Use of antibiotics or laxatives in the previous month
• History of substance abuse or alcohol abuse
• involvement in a weight loss intervention program within the past month or weight change \> 10%
• Self-report of allergic reactions to study products or their phytochemicals.

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

Nutrition Department, Ragle Facility, University of California Davis

Davis, California, 95616, United States

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gerardo G Macknezie, PhD

  Univeristy of California Davis

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: April 25, 2025
• Study Start: May 17, 2025
• Primary Completion: October 1, 2025
• Study Completion: March 6, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)