- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02627547
Impact of Training Status on Bioavailability of Flavanones
Impact of Training Status of Endurance Athletes on Bioavailability of Flavanones
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:
- Determine the effects of training status of endurance athletes on bioavailability of flavanones in endurance trained individuals
- Determine whether changes in bioavailability of flavanones are related to changes in biomarkers of inflammation, oxidative stress, plasma lipids and insulin sensitivity.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Glasgow, United Kingdom
- University of Glasgow School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- history of gastrointestinal disease
- vegetarian
- unstable food habits
- VO2 max < 50 ml/kg body mass
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental tests
2 sets of experimental tests; once, during a period of normal training and repeated following one week of de-training
|
5-10 hours of endurance training each week
No training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
• Plasma pharmacokinetics of naringenin, hesperetin, eriodictyol, isorhamnetin and phenolic acid metabolites
Time Frame: 24 hours
|
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
Time Frame: 24 hours
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximal Oxygen Consumption
Time Frame: 30 minutes
|
Maximal Oxygen Consumption (ml/kg/min) measured in trained state by Douglas bag method
|
30 minutes
|
Body weight
Time Frame: 7 days
|
Difference in body weight in kilograms between trained and detrained states measured by TANITA scales (TBF-300, Cranlea, UK)
|
7 days
|
Body fatness
Time Frame: 7 days
|
Difference in percentage of body fat between trained and detrained states measured by bioelectrical impedance method (TBF-300, TANITA, Cranlea, UK)
|
7 days
|
Dietary Intake
Time Frame: 7 days
|
Difference in energy/macronutrient intake between trained and detrained states measured from 7 day weighted food records
|
7 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dalia Malkova, University of Glasgow
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 200120075
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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