Impact of Training Status on Bioavailability of Flavanones

Healthy Clinical Trial

Official title:

Impact of Training Status of Endurance Athletes on Bioavailability of Flavanones

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02627547
• Other study ID #: 200120075
• Status: Completed
• Phase: N/A
• First received: December 2, 2015
• Last updated: December 8, 2015
• Start date: September 2013
• Est. completion date: August 2015

Study information

• Verified date: December 2015
• Source: University of Glasgow
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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. Determine the effects of training status of endurance athletes on bioavailability of flavanones in endurance trained individuals

2. Determine whether changes in bioavailability of flavanones are related to changes in biomarkers of inflammation, oxidative stress, plasma lipids and insulin sensitivity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Behavioral:
• Normal training
5-10 hours of endurance training each week
• De-training
No training

Locations

Country	Name	City	State
United Kingdom	University of Glasgow School of Medicine	Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• 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	No
Primary	• 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	No
Secondary	Maximal Oxygen Consumption	Maximal Oxygen Consumption (ml/kg/min) measured in trained state by Douglas bag method	30 minutes	No
Secondary	Body weight	Difference in body weight in kilograms between trained and detrained states measured by TANITA scales (TBF-300, Cranlea, UK)	7 days	No
Secondary	Body fatness	Difference in percentage of body fat between trained and detrained states measured by bioelectrical impedance method (TBF-300, TANITA, Cranlea, UK)	7 days	No
Secondary	Dietary Intake	Difference in energy/macronutrient intake between trained and detrained states measured from 7 day weighted food records	7 days	No