NCT02195934

Brief Summary

This study aims to compare the effect of an anthocyanin-rich blood orange juice with a standard (no anthocyanin) blonde orange juice on markers of cardiovascular disease (CVD). Participants aged between 25 and 84 years of age will be recruited into a single arm, two way cross-over study based on their waist measurement, with 42 individuals required to complete the study. Participants will each receive two interventions in a randomised order: 500mL blood orange juice daily for 28 days, and 500ml standard (blonde) orange juice daily for 28 days. Prior to each intervention there will be a 2 week "run in period" where participants will be asked to avoid consuming foods rich in anthocyanins. After the first 28 day intervention period, there will be a 3 week wash out period after which the participants will be asked to then drink the other juice for 28 days. The 500 mL of blood orange juice contains approximately 50mg of anthocyanins, whereas the standard juice contains none. Blood samples will be collected for the preparation of plasma and peripheral blood mononuclear cells (PBMCs) for the analysis of anthocyanin metabolite concentrations, transcriptomics and CVD risk markers. Urine samples will be collected and urinary excretion of anthocyanin metabolites will be quantified. Other measurements will include pulse wave analysis, pulse wave velocity, central blood pressure, waist and hip circumference, blood glucose, glycated haemoglobin (HbA1C) and insulin concentrations, and various measurements using the TANITA machine which include weight, fat mass, muscle mass, fat percentage, fat-free mass, total body water, bone mass, metabolic age, basal metabolic rate, visceral fat rating, and degree of obesity. All measurements and samples will be taken at baseline and post intervention for each phase of the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable

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

Study Start

First participant enrolled

July 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 21, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

September 5, 2016

Status Verified

April 1, 2016

Enrollment Period

2.1 years

First QC Date

July 18, 2014

Last Update Submit

September 2, 2016

Conditions

Cardiovascular Disease

Keywords

Cardiovascular disease, blood orange juice, anthocyanins

Outcome Measures

Primary Outcomes (1)

  • LDL cholesterol

    The primary outcome measure will be the change in concentration of LDL cholesterol as a result of the daily consumption of standard (blonde) orange juice or blood orange juice for 28 days (4 weeks).

    28 days (4 weeks)

Secondary Outcomes (1)

  • CVD biomarkers

    28 days (4 weeks)

Other Outcomes (1)

  • Gene expression

    28 days (4 weeks)

Study Arms (2)

Standard orange juice (OJ) followed by blood OJ

OTHER

This randomized 2-way cross over study will compare the effect of blood orange juice with that of a standard (blonde) orange juice consumed daily for 28 days, on markers of cardiovascular disease, with a 3 week washout period in between.

Other: Standard (blonde) orange juiceOther: Blood orange juice

Blood orange juice followed by standard OJ

OTHER

This randomized 2-way cross over study will compare the effect of blood orange juice with that of a standard (blonde) orange juice consumed daily for 28 days, on markers of cardiovascular disease, with a 3 week washout period in between.

Other: Standard (blonde) orange juiceOther: Blood orange juice

Interventions

Standard (blonde) orange juiceOTHER

Consumption of 500ml standard (blonde) orange juice daily for 28 days

Blood orange juice followed by standard OJStandard orange juice (OJ) followed by blood OJ
Blood orange juiceOTHER

Consumption of 500ml blood orange juice daily for 28 days

Blood orange juice followed by standard OJStandard orange juice (OJ) followed by blood OJ

Eligibility Criteria

Age25 Years - 84 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women aged 25-84 years
  • Waist measurement
  • Caucasians: Men \> 102cm (40inches); Women \>88cm (34inches)
  • Asians: Men\> 90cm (35inches); Women 80cm (31inches)

You may not qualify if:

  • Those unable to give written informed consent
  • Those unwilling to provide general practitioner (GP) details
  • Regular prescribed medication that may affect study outcome. This will be assessed on an individual basis-not including statins
  • Over-the-counter (non-prescribed) medication that may affect the study data. This will be assessed on an individual basis.
  • Allergy to the test juice drink or the actual fruit itself
  • Chronic medical conditions requiring active treatment. This will be assessed on an individual basis
  • Those already consuming blood orange juice, unless they are willing to discontinue consumption for 2 weeks prior to starting the study.
  • Diagnosed diabetics;
  • Peri-menopausal women (defined as: when there is a permanent change in menstrual cycle)
  • Women on hormone replacement therapy (HRT) for less than one year
  • On thyroxine for less than one year
  • Women who are pregnant, have been pregnant within the last 12 months or who are breastfeeding
  • Those taking aspirin (prescribed or self-prescribed)
  • All blood pressure medication
  • Those individuals who happen to be on statins will be excluded if they have been on statins for less than 3 months; or if they are not taking on a daily basis; or those who have recently changed their dosage of statins. This will be assessed on an individual basis
  • +20 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Food Research

Norwich, Norfolk, NR4 7UA, United Kingdom

Location

Related Publications (1)

  • Hollands WJ, Armah CN, Doleman JF, Perez-Moral N, Winterbone MS, Kroon PA. 4-Week consumption of anthocyanin-rich blood orange juice does not affect LDL-cholesterol or other biomarkers of CVD risk and glycaemia compared with standard orange juice: a randomised controlled trial. Br J Nutr. 2018 Feb;119(4):415-421. doi: 10.1017/S0007114517003865.

    PMID: 29498348DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Paul A Kroon, PhD

    Quadram Institute Bioscience

    STUDY DIRECTOR

  • Charlotte N Armah, PhD

    Quadram Institute Bioscience

    PRINCIPAL INVESTIGATOR

  • Joanne F Doleman, PhD

    Quadram Institute Bioscience

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2014

First Posted

July 21, 2014

Study Start

July 1, 2014

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

September 5, 2016

Record last verified: 2016-04

Locations

GB(1)