NCT02627547

Brief Summary

Flavonoids are compounds that have been proven to have a beneficial effect on health, such as reducing the risk of developing cardiovascular disease and, in some cases, cancer. Citrus juices have a high flavonoid content. However, the absorption of flavonoids into the body is limited. This study will investigate whether being physically active improves the absorption of flavonoids. Endurance trained athletes will be invited to participate. Following screening procedures (a. Health Screening Questionnaire; b. height and weight measurement for calculation of Body Mass Index; c. maximal oxygen consumption (VO2max) uptake test, eligible participants will undertake two experimental tests; one during a period of normal training, the other immediately following 1 week of detraining. In the morning of the experimental trial participants will consume 500 mL of orange juice. Blood samples and urinary fractions will be collected prior (base line) to and for 24 hours after orange juice consumption. Participants will be asked to follow a special polyphenol-free diet and record weighed dietary intake for 2 days preceding each trial and during the day of the experimental trial. The study aims to:

  1. 1.Determine the effects of training status of endurance athletes on bioavailability of flavanones in endurance trained individuals
  2. 2.Determine whether changes in bioavailability of flavanones are related to changes in biomarkers of inflammation, oxidative stress, plasma lipids and insulin sensitivity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable healthy

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

September 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 11, 2015

Completed
Last Updated

December 11, 2015

Status Verified

December 1, 2015

Enrollment Period

1.9 years

First QC Date

December 2, 2015

Last Update Submit

December 8, 2015

Conditions

Healthy

Keywords

FlavanonesEndurance-trained athletesBiological availability

Outcome Measures

Primary Outcomes (2)

  • • Plasma pharmacokinetics of naringenin, hesperetin, eriodictyol, isorhamnetin and phenolic acid metabolites

    Change in plasma concentrations collected at base line (0 hours) and 0.5,1, 2, 3,4,5,6,7,8, and 24 hours after ingestion of orange juice

    24 hours

  • • Urinary excretion of naringenin, hesperetin, eriodictyol, isorhamnetin and phenolic acid metabolites

    Change in concentrations in urinary fraction collected at base line (0 hours) and after ingestion of orange juice (0-5, 5-8, 8-10, 10-24 hours)

    24 hours

Secondary Outcomes (4)

  • Maximal Oxygen Consumption

    30 minutes

  • Body weight

    7 days

  • Body fatness

    7 days

  • Dietary Intake

    7 days

Study Arms (1)

Experimental tests

EXPERIMENTAL

2 sets of experimental tests; once, during a period of normal training and repeated following one week of de-training

Behavioral: Normal trainingBehavioral: De-training

Interventions

Normal trainingBEHAVIORAL

5-10 hours of endurance training each week

Experimental tests
De-trainingBEHAVIORAL

No training

Experimental tests

Eligibility Criteria

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

You may qualify if:

  • trained regularly for at least 4 years and typically perform at least 5 hours of endurance training per week (distance runners, triathletes, cyclists)
  • healthy
  • normotensive
  • non-smokers
  • not taking any drug therapies
  • VO2 max \>50 ml/kg body mass

You may not qualify if:

  • history of gastrointestinal disease
  • vegetarian
  • unstable food habits
  • VO2 max \< 50 ml/kg body mass

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Glasgow School of Medicine

Glasgow, United Kingdom

Location

Related Publications (2)

  • Pereira-Caro G, Clifford MN, Polyviou T, Ludwig IA, Alfheeaid H, Moreno-Rojas JM, Garcia AL, Malkova D, Crozier A. Plasma pharmacokinetics of (poly)phenol metabolites and catabolites after ingestion of orange juice by endurance trained men. Free Radic Biol Med. 2020 Nov 20;160:784-795. doi: 10.1016/j.freeradbiomed.2020.09.007. Epub 2020 Sep 11.

    PMID: 32927016DERIVED

  • Pereira-Caro G, Polyviou T, Ludwig IA, Nastase AM, Moreno-Rojas JM, Garcia AL, Malkova D, Crozier A. Bioavailability of orange juice (poly)phenols: the impact of short-term cessation of training by male endurance athletes. Am J Clin Nutr. 2017 Sep;106(3):791-800. doi: 10.3945/ajcn.116.149898. Epub 2017 Jul 26.

    PMID: 28747329DERIVED

Study Officials

  • Dalia Malkova

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

December 2, 2015

First Posted

December 11, 2015

Study Start

September 1, 2013

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

December 11, 2015

Record last verified: 2015-12

Locations

GB(1)