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

NCT ID: NCT06944210

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-17
• Study Completion Date: 2026-01-30

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.

Detailed Description

The health benefits of orange consumption have been described; however, the specific bioactive compounds responsible for these effects, as well as the underlying mechanisms of action, are not fully understood. There are several varieties of sweet oranges, each with a unique phytochemical profile and potentially distinct health-promoting properties. The 'Rosy Red Valencia' sweet orange is enriched in carotenoids such as lycopene, phytoene, and phytofluene, whereas the commonly consumed 'Olinda Valencia' contains negligible levels of these compounds.

This randomized, parallel-arm clinical trial aims to evaluate and compare the antioxidant and anti-inflammatory effects of 'Rosy Red Valencia' and 'Olinda Valencia' sweet orange consumption in healthy men and women. Participants will be randomized to consume one of the two orange varieties twice daily for four weeks.

The study includes both an acute phase (1-day consumption) and a chronic phase (4-week daily consumption). Blood samples will be collected at baseline, after 1 day, and after 4 weeks of consumption to assess changes in plasma carotenoid concentrations, markers of oxidative stress and inflammation, and gene expression profiles in peripheral blood mononuclear cells. Fecal samples will be collected at baseline and after 4 weeks to assess the effects on gut microbiota composition. By evaluating and comparing the biological effects of these two orange varieties, the study aims to elucidate the role of specific carotenoids in mediating the health benefits of sweet orange consumption.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

'Rosy Red Valencia' sweet orange variety

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

Group Type: EXPERIMENTAL

'Rosy Red Valencia' sweet orange

Intervention Type: OTHER

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

'Olinda Valencia' sweet orange variety

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

Group Type: EXPERIMENTAL

'Olinda Valencia' sweet oranges

Intervention Type: OTHER

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

Interventions

'Rosy Red Valencia' sweet orange

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

Intervention Type: OTHER

'Olinda Valencia' sweet oranges

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerardo G Macknezie, PhD

Role: STUDY_DIRECTOR

Univeristy of California Davis

Locations

Nutrition Department, Ragle Facility, University of California Davis

Davis, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Irena Krga, PhD

Role: CONTACT

ikrga@ucdavis.edu

+1530-752-6554‬

Facility Contacts

Irena Krga, PhD

Role: primary

ikrga@ucdavis.edu

+1 530-752-6554‬

Other Identifiers

22923441

Identifier Type: -

Identifier Source: org_study_id