Sweet Oranges for Health Benefits

Overseen By Irena Krga, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Must not be taking: Antibiotics, Laxatives

Disqualifiers: Cardiovascular, Diabetes, Hypertension, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you will need to stop using antioxidant supplements, prebiotics, and probiotics.

What data supports the effectiveness of the treatment 'Olinda Valencia' and 'Rosy Red Valencia' sweet oranges for health benefits?

Research on similar sweet orange varieties, like Moro blood oranges, shows they can help with weight loss and reduce body fat in overweight individuals. These oranges contain compounds that may improve antioxidant and anti-inflammatory responses, which could contribute to their health benefits. ^{1 2 3 4 5}

Is sweet orange juice safe for human consumption?

Research on different types of sweet orange juice, like Moro and red orange juice, shows no significant safety concerns for humans when consumed in typical amounts. However, people with certain health conditions, such as severe hypertension (high blood pressure) or those taking specific medications, should be cautious and consult a doctor before consuming. ^{1 2 4 6 7}

How does the 'Olinda Valencia' sweet orange treatment differ from other treatments?

The 'Olinda Valencia' sweet orange treatment is unique because it contains high levels of carotenoids, such as lycopene and phytoene, which contribute to its strong antioxidant capacity. This makes it potentially beneficial for reducing oxidative stress, a feature not commonly emphasized in other treatments for similar conditions. ^{1 2 5 8 9}

What is the purpose of this trial?

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.

Research Team

Gerardo G Macknezie, PhD

Principal Investigator

Univeristy of California Davis

Eligibility Criteria

This trial is for healthy adults interested in participating in a study evaluating the health benefits of two types of sweet oranges. Participants will be required to consume either 'Rosy Red Valencia' or 'Olinda Valencia' oranges daily for 4 weeks.

Inclusion Criteria

Body mass index (BMI) with values between 21 and 29.9 kg/m2

I am between 25 and 40 years old.

Willingness to refrain from consuming foods rich in lycopene, phytoene, and phytofluene and limit the intake of some polyphenol-rich foods

Exclusion Criteria

Pregnancy/lactation

Self-report of allergic reactions to study products or their phytochemicals

Psychiatric disease that interferes with the understanding and implementation of the intervention

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Acute Phase

Participants consume either 'Rosy Red Valencia' or 'Olinda Valencia' oranges for 1 day to assess immediate effects

1 day

1 visit (in-person)

Chronic Phase

Participants consume either 'Rosy Red Valencia' or 'Olinda Valencia' oranges daily for 4 weeks to assess long-term effects

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• 'Olinda Valencia' sweet orange
• 'Rosy Red Valencia' sweet orange

Trial Overview 'Rosy Red Valencia', rich in carotenoids like lycopene, and 'Olinda Valencia', which lacks these compounds, are being tested for their antioxidant and anti-inflammatory effects on healthy subjects over a period of 4 weeks.

Participant Groups

Group I: 'Rosy Red Valencia' sweet orange variety Experimental Treatment 1 Intervention

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

Group II: 'Olinda Valencia' sweet orange variety Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Findings from Research

Red-fleshed sweet orange juice (ROJ) and blond orange juice (BOJ) both showed cytotoxic effects on T acute lymphoblastic leukemia cells (Loucy), indicating their potential as chemopreventive agents.

BOJ was particularly effective, causing cell cycle arrest in the G0/G1 phase and inducing apoptosis through increased late apoptosis and necrosis, while ROJ primarily increased early and late apoptosis without affecting the cell cycle as significantly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemopreventive Actions of Blond and Red-Fleshed Sweet Orange Juice on the Loucy Leukemia Cell Line. Dourado, GK., Stanilka, JM., Percival, SS., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Clinical evaluation of Moro (Citrus sinensis (L.) Osbeck) orange juice supplementation for the weight management. [2015]

2. England pubmed.ncbi.nlm.nih.gov

Blood orange juice inhibits fat accumulation in mice. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of "Moro" Blood Orange Citrus sinensis Osbeck (Rutaceae) Standardized Extract on Weight Loss in Overweight but Otherwise Healthy Men and Women-A Randomized Double-Blind Placebo-Controlled Study. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of Red Orange Juice Consumption on Body Composition and Nutritional Status in Overweight/Obese Female: A Pilot Study. [2018]

5. Thailand pubmed.ncbi.nlm.nih.gov

Chemopreventive Actions of Blond and Red-Fleshed Sweet Orange Juice on the Loucy Leukemia Cell Line. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a feed additive consisting of a flavonoid-rich dried extract of Citrus × aurantium L. fruit (bitter orange extract) for use in all animal species (FEFANA asbl). [2021]

7. England pubmed.ncbi.nlm.nih.gov

Seville (sour) orange juice: synephrine content and cardiovascular effects in normotensive adults. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Bioactive Compounds, Nutritional Quality and Antioxidant Capacity of the Red-Fleshed Kirkwood Navel and Ruby Valencia Oranges. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Antioxidant capacity in fruit of Citrus cultivars with marked differences in pulp coloration: Contribution of carotenoids and vitamin C. [2021]