HealthyNCT02627547
Impact of Training Status on Bioavailability of Flavanones
A study testing Normal training and De-training in people with Healthy, run by University of Glasgow at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Normal training and De-training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2013to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- history of gastrointestinal disease
- vegetarian
- unstable food habits
- VO2 max < 50 ml/kg body mass
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Healthy
- Being tested
- Normal training, De-training
- Keywords
- Flavanones, Endurance-trained athletes, Biological availability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal trainingBehavioural
5-10 hours of endurance training each week
De-trainingBehavioural
No training
| Study group | Role | What they receive |
|---|---|---|
| Experimental tests | Experimental | 2 sets of experimental tests; once, during a period of normal training and repeated following one week of de-training Receives: Behavioral: Normal training; Behavioral: De-training |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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
Measured: 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)
Measured: 24 hours
Secondary outcomes (4)
Maximal Oxygen Consumption
Maximal Oxygen Consumption (ml/kg/min) measured in trained state by Douglas bag method
Measured: 30 minutes
Body weight
Difference in body weight in kilograms between trained and detrained states measured by TANITA scales (TBF-300, Cranlea, UK)
Measured: 7 days
Body fatness
Difference in percentage of body fat between trained and detrained states measured by bioelectrical impedance method (TBF-300, TANITA, Cranlea, UK)
Measured: 7 days
Dietary Intake
Difference in energy/macronutrient intake between trained and detrained states measured from 7 day weighted food records
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startSep 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Dalia Malkova, University of Glasgow
- Investigators
- Dalia Malkova, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02627547
- Sponsor's protocol ID
- 200120075
- Status last verified
- Dec 2015
- First submitted
- 2 Dec 2015
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 32927016Pereira-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.
PubMed 28747329
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Training Status of Endurance Athletes on Bioavailability of Flavanones
- ClinicalTrials.gov ID
- NCT02627547
- Acronym / sponsor ID
- 200120075
- Conditions
- Healthy
- Keywords
- Flavanones, Endurance-trained athletes, Biological availability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 11 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental tests | Experimental | Behavioral: Normal training, Behavioral: De-training2 sets of experimental tests; once, during a period of normal training and repeated following one week of de-training |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- history of gastrointestinal disease
- vegetarian
- unstable food habits
- VO2 max < 50 ml/kg body mass
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal training5-10 hours of endurance training each week | Behavioural | Experimental tests |
| De-trainingNo training | Behavioural | Experimental tests |
Primary outcome
• 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
• 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)
4 secondary outcomes
Maximal Oxygen Consumption
Time frame: 30 minutes
Body weight
Time frame: 7 days
Body fatness
Time frame: 7 days
Dietary Intake
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
- Derived from this study: PubMed 32927016Pereira-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.
- Derived from this study: PubMed 28747329Pereira-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.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dalia Malkova principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal training and De-training in people with Healthy, run by University of Glasgow at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Plasma pharmacokinetics of naringenin, hesperetin, eriodictyol, isorhamnetin and phenolic acid metabolites (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02627547, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2015.