NCT02479568

Brief Summary

The primary aim is to examine both the acute and chronic effects of hesperidin consumption from 100% Florida orange juice in various doses on functional and systemic markers associated with cardiovascular disease (CVD) risks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

January 12, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2017

Completed
Last Updated

February 28, 2022

Status Verified

February 1, 2022

Enrollment Period

1.5 years

First QC Date

June 17, 2015

Last Update Submit

February 25, 2022

Conditions

Cardiovascular Risk Factors

Keywords

Cardiovascular diseasebiomarkerstranscriptomicsorange juicehesperidinsystolic blood pressuremetabolomicscardiovascular risk factor

Outcome Measures

Primary Outcomes (1)

  • Systolic Blood Pressure

    During each visit, SBP will be measured after 5 min in a seated position in a comfortable room by the physician. The measurement will be taken in duplicate at 1-min intervals using an automatic sphygmomanometer (OMRON HEM-907; Peroxfarma, Barcelona, Spain), and the average of the two measurements will be calculated.

    Every 2 weeks for a total of 12 weeks.

Secondary Outcomes (6)

  • Diastolic Blood Pressure

    Every 2 weeks for a total of 12 weeks.

  • Ischemic reactive hyperemia (IRH)

    Every 4 weeks for a total of 12 weeks

  • Platelet aggregation

    Every 4 weeks for a total of 12 weeks

  • Homocysteine

    Every 4 weeks for a total of 12 weeks

  • C-reactive protein (inflammatory marker)

    Every 4 weeks for a total of 12 weeks

  • +1 more secondary outcomes

Other Outcomes (2)

  • Transcriptomics

    At week 0 (V1) and 12 week (V7).

  • Non-targeted Metabolomics

    At week 0 (V1) and 12 week (V7).

Study Arms (3)

Control

ACTIVE COMPARATOR

Control drink (placebo)

Dietary Supplement: Control

Natural Florida orange juice

EXPERIMENTAL

100% Florida orange juice (OJ) (natural content of hesperidin)

Dietary Supplement: 100% Florida OJ

Enriched Florida orange juice

EXPERIMENTAL

100% Florida orange juice (OJ) (enriched hesperidin content)

Dietary Supplement: 100% Florida OJ-enriched

Interventions

ControlDIETARY_SUPPLEMENT

500 mL (250 mL; 2 times/day) of placebo drink for 12 weeks

Control
100% Florida OJDIETARY_SUPPLEMENT

500 mL (250 mL; 2 times/day) of 100% Florida OJ for 12 weeks

Natural Florida orange juice
100% Florida OJ-enrichedDIETARY_SUPPLEMENT

500 mL (250 mL; 2 times/day) of 100% Florida OJ-enriched for 12 weeks

Enriched Florida orange juice

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • Failure to follow the study guidelines.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Technological Centre of Nutrition and Health (CTNS)

Reus, Tarragona, 43204, Spain

Location

Related Links

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Rosa Solà Alberich, Prof, MD

    • University Rovira i Virgili / Hospital Universitari Sant Joan de Reus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2015

First Posted

June 24, 2015

Study Start

January 12, 2016

Primary Completion

July 6, 2017

Study Completion

July 6, 2017

Last Updated

February 28, 2022

Record last verified: 2022-02

Locations

ES(1)