Beneficial Impact of Orange Juice Consumption on Risk Factors Associated With Cardiovascular Diseases

• Register: ClinicalTrials.gov
• Last refreshed on: 7 March 2022
• Main ID: NCT02479568
• Date of registration: 17/06/2015
• Prospective Registration: Yes
• Primary sponsor: Technological Centre of Nutrition and Health, Spain
• Public title: Beneficial Impact of Orange Juice Consumption on Risk Factors Associated With Cardiovascular Diseases CITRUS
• Scientific title: Randomized, Parallel and Double Blind Placebo-controlled Study for the Evaluation of Both Acute and Chronic Role of Hesperidin Consumption in 100% Orange Juice
• Date of first enrolment: January 12, 2016
• Target sample size: 159
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02479568
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Spain

Contacts

• Name: Rosa Solà Alberich, Prof, MD
• Affiliation: • University Rovira i Virgili / Hospital Universitari Sant Joan de Reus

Key inclusion & exclusion criteria

Inclusion criteria

- Men or women 18-65 years old

- No evidence of chronic disease

- No familial CVD history

- Written informed consent provided before the initial screening visit.

- Blood pressure (with no drug intervention) >120 mm Hg systolic blood pressure = 159
mmHg

Exclusion criteria

- Body mass index (BMI) = 35 kg/m2

- Glucose >125 mg/dl

- Systolic blood pressure = 160 mm Hg and diastolic blood pressure >100 mm Hg or taking
antihypertensive medications

- Total cholesterol >240 mg/dl

- LDL-cholesterol >160 md/dl

- TAG >350

- Smoking

- Pregnant or intending to become pregnant

- Use of medications, antioxidants, or vitamin supplements

- Chronic alcoholism

- Intense physical activity (5h/week)

- Intestinal disorders

- Following of a vegetarian diet

- Anemia (hemoglobin =13 g/dL in men and =12 g/dL in women)

- Current or past participation in a clinical trial or consumption of a research product
in the 30 days prior to inclusion in the study

- Failure to follow the study guidelines.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cardiovascular Risk Factors

Intervention(s)

Dietary Supplement: Control

Dietary Supplement: 100% Florida OJ-enriched

Dietary Supplement: 100% Florida OJ

Primary Outcome(s)

Systolic Blood Pressure [Time Frame: Every 2 weeks for a total of 12 weeks.]

Secondary Outcome(s)

oxidized LDL (as oxidative stress biomarker) [Time Frame: Every 4 weeks for a total of 12 weeks]

Ischemic reactive hyperemia (IRH) [Time Frame: Every 4 weeks for a total of 12 weeks]

C-reactive protein (inflammatory marker) [Time Frame: Every 4 weeks for a total of 12 weeks]

Diastolic Blood Pressure [Time Frame: Every 2 weeks for a total of 12 weeks.]

Homocysteine [Time Frame: Every 4 weeks for a total of 12 weeks]

Platelet aggregation [Time Frame: Every 4 weeks for a total of 12 weeks]

Secondary ID(s)

CITRUS 14-12

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Technological Centre of Nutrition and Health

Florida Department of Citrus

Hospital Universitari Sant Joan de Reus

University Rovira i Virgili