AgingNCT04370353
Impact of Cocoa Flavanols on Pulmonary Oxygen Uptake Kinetics and Exercise Tolerance in Sedentary Middle-aged Adults
A study testing Cocoa flavanols in people with Aging and Sedentary Behavior, run by Liverpool John Moores University at 1 site in United Kingdom.
Trial summary
In recent years, there has been significant interest in dietary flavonoids (biologically active plant-derived compounds) as potential therapeutics. This is due to the capacity of flavonoids to enhance processes related to energy metabolism and cardiovascular health. Read more about this study
- Who is it for?
- Ages 35 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Sedentary Behavior
- What is being tested?
- Cocoa flavanols
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2018to 7 Jun 2019
- 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 35 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 35-55 years
- Healthy (no known cardiovascular or metabolic disorders e.g. diabetes)
- Do not engage in regular structured physical training (i.e. less than two sessions for 60 minutes per week, for at least 1 year
Who cannot join
- Smokers
- Medical history of cardiovascular and/or metabolic disease, including diabetes and abnormal blood pressure
- Family history of cardiovascular disease
- Currently taking any medication
- Asthmatic
- Currently suffering from musculoskeletal injury
Show all 10Show fewer
- Younger than 35 or older than 55 years old
- Known food allergies or special dietary requirements
- Currently taking any dietary supplements
- Currently engaging in >2 hours structured training per week
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Research Institute for Sport & Exercise Sciences
Liverpool
About this study
Official title: Investigating the Impact of Cocoa Flavanol Supplementation on Pulmonary Oxygen Uptake Kinetics and Exercise Tolerance in Sedentary Middle-aged Adults
In recent years, there has been significant interest in dietary flavonoids (biologically active plant-derived compounds) as potential therapeutics. This is due to the capacity of flavonoids to enhance processes related to energy metabolism and cardiovascular health. We are interested in implementing a short-term supplementation regime (daily cocoa-flavanoid ingestion), in order to explore the possible beneficial effects of flavonoid-based interventions on responses to exercise. Hence, the objective of our study is to examine the impact of short term cocoa-flavanoid supplementation on processes related to energy use (oxygen utilisation). Our aim is to develop a novel intervention which improves cardiovascular health and enhances exercise tolerance.
- Conditions
- Aging, Sedentary Behavior
- Being tested
- Cocoa flavanols, Placebo supplement
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cocoa flavanolsDietary supplement
Flavonoid-rich cocoa powder, containing 100mg total flavanols per 316mg.
Placebo supplementDietary supplement
Microcrystalline filler, containing 0mg total flavanols.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo supplement, each capsule containing: 0mg total flavanols, matched for caffeine and theobromine content as experimental supplement (2.9 mg caffeine and 22.5 mg theobromine) and microcrystalline cellulose volume filler. Participants consume 4x capsules daily (2AM \& 2PM after mixed meal for 7 days. Receives: Dietary Supplement: Placebo supplement |
| Cocoa Flavanols | Experimental | Experimental supplement, each capsule containing: 316 mg CocoActiv (Naturex, Netherlands: 100mg total cocoa flavanols, 2.9 mg caffeine and 22.5 mg theobromine) and microcrystalline cellulose volume filler. Participants consume 4x capsules daily (2AM \& 2PM) for 7 days. Receives: Dietary Supplement: Cocoa flavanols |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen uptake kinetics
Oxygen uptake kinetics (including time constant, time delay and amplitude of the fundamental oxygen uptake response) will be determined by modelling oxygen uptake during exercise using a mono exponential function. The oxygen uptake data is measured on a breath-by-breath basis during exercise (on a cycle ergometer) using a gas analysis system and face mask. Oxygen kinetics will be measured during three moderate-intensity step exercise tests (at 80% of the gas exchange threshold) and during one severe-intensity (60%∆) step exercise test that is completed to failure.
Measured: Over 3 week period (After 7 days of each intervention). Oxygen uptake measured for 9 minutes continuously during exercise bouts (3 min warm up period and 6 minutes of exercise transition)
Exercise tolerance
Participants capacity to exercise to the limit of tolerance, measured to the nearest second. Participants are instructed to exercise at a severe-intensity exercise load (representative of 60% ∆), on a cycle ergometer until volitional exhaustion.
Measured: Over 3 week period (After 7 days of each intervention).
Secondary outcomes (5)
Heart rate
Heart rate will be measured during moderate and severe-intensity exercise bouts, by short-range telemetry.
Measured: Over 3 week period (After 7 days of each intervention). Measured during the length of each exercise transition (9 minutes for each moderate intensity bout).
Blood pressure
Systolic and diastolic blood pressure will be assessed following 10 min of seated rest using an automated sphygmomanometer
Measured: Over 3 week period (After 7 days of each intervention). Measured over 5 minutes before any exercise testing.
Blood lactate
A finger prick blood sample will be taken to measure blood lactate pre- and post-exercise of each transition using a hand-held automated blood lactate analyser
Measured: Over 3 week period (After 7 days of each intervention). Measured immediately before and after exercise
Physical activity and sedentary behaviour
Physical activity levels will be assessed in the 6 days prior to visiting the laboratory by an accelerometer, worn on the hip during waking hours.
Measured: Over 3 week period (In the 6 days preceding experimental testing)
Perceived workload
Perceived mental workload will be measured pre and post exercise using NASA Task Load Index and BORG rating of perceived exertion scale.
Measured: Over 3 week period (After 7 days of each intervention). Measured immediately before and after exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start1 Apr 2018
- Primary completion7 Jun 2019
- Study completion7 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04370353
- Sponsor's protocol ID
- 18/SPS/014
- Status last verified
- Apr 2020
- First submitted
- 23 Apr 2020
- Last updated
- 30 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sadler DG, Draijer R, Stewart CE, Jones H, Marwood S, Thijssen DHJ. Cocoa-flavanols enhance moderate-intensity pulmonary V O 2 kinetics but not exercise tolerance in sedentary middle-aged adults. Eur J Appl Physiol. 2021 Aug;121(8):2285-2294. doi: 10.1007/s00421-021-04682-9. Epub 2021 May 10.
PubMed 33970327
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of Cocoa Flavanol Supplementation on Pulmonary Oxygen Uptake Kinetics and Exercise Tolerance in Sedentary Middle-aged Adults
- ClinicalTrials.gov ID
- NCT04370353
- Acronym / sponsor ID
- 18/SPS/014
- Conditions
- Aging, Sedentary Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 7 Jun 2019 (actual)
- Study completion
- 7 Jun 2019 (actual)
- First posted
- 30 Apr 2020 (actual)
- 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.
In recent years, there has been significant interest in dietary flavonoids (biologically active plant-derived compounds) as potential therapeutics. This is due to the capacity of flavonoids to enhance processes related to energy metabolism and cardiovascular health. We are interested in implementing a short-term supplementation regime (daily cocoa-flavanoid ingestion), in order to explore the possible beneficial effects of flavonoid-based interventions on responses to exercise. Hence, the objective of our study is to examine the impact of short term cocoa-flavanoid supplementation on processes related to energy use (oxygen utilisation). Our aim is to develop a novel intervention which improves cardiovascular health and enhances exercise tolerance.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo supplementPlacebo supplement, each capsule containing: 0mg total flavanols, matched for caffeine and theobromine content as experimental supplement (2.9 mg caffeine and 22.5 mg theobromine) and microcrystalline cellulose volume filler. Participants consume 4x capsules daily (2AM \& 2PM after mixed meal for 7 days. |
| Cocoa Flavanols | Experimental | Dietary Supplement: Cocoa flavanolsExperimental supplement, each capsule containing: 316 mg CocoActiv (Naturex, Netherlands: 100mg total cocoa flavanols, 2.9 mg caffeine and 22.5 mg theobromine) and microcrystalline cellulose volume filler. Participants consume 4x capsules daily (2AM \& 2PM) for 7 days. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 35-55 years
- Healthy (no known cardiovascular or metabolic disorders e.g. diabetes)
- Do not engage in regular structured physical training (i.e. less than two sessions for 60 minutes per week, for at least 1 year
Key exclusion criteria (10 listed)
- Smokers
- Medical history of cardiovascular and/or metabolic disease, including diabetes and abnormal blood pressure
- Family history of cardiovascular disease
- Currently taking any medication
- Asthmatic
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 |
|---|---|---|
| Cocoa flavanolsFlavonoid-rich cocoa powder, containing 100mg total flavanols per 316mg. | Dietary supplement | Cocoa Flavanols |
| Placebo supplementMicrocrystalline filler, containing 0mg total flavanols. | Dietary supplement | Placebo |
Primary outcome
Oxygen uptake kinetics
Time frame: Over 3 week period (After 7 days of each intervention). Oxygen uptake measured for 9 minutes continuously during exercise bouts (3 min warm up period and 6 minutes of exercise transition)
Oxygen uptake kinetics (including time constant, time delay and amplitude of the fundamental oxygen uptake response) will be determined by modelling oxygen uptake during exercise using a mono exponential function. The oxygen uptake data is measured on a breath-by-breath basis during exercise (on a cycle ergometer) using a gas analysis system and face mask. Oxygen kinetics will be measured during three moderate-intensity step exercise tests (at 80% of the gas exchange threshold) and during one severe-intensity (60%∆) step exercise test that is completed to failure.
Exercise tolerance
Time frame: Over 3 week period (After 7 days of each intervention).
Participants capacity to exercise to the limit of tolerance, measured to the nearest second. Participants are instructed to exercise at a severe-intensity exercise load (representative of 60% ∆), on a cycle ergometer until volitional exhaustion.
5 secondary outcomes
Heart rate
Time frame: Over 3 week period (After 7 days of each intervention). Measured during the length of each exercise transition (9 minutes for each moderate intensity bout).
Blood pressure
Time frame: Over 3 week period (After 7 days of each intervention). Measured over 5 minutes before any exercise testing.
Blood lactate
Time frame: Over 3 week period (After 7 days of each intervention). Measured immediately before and after exercise
Physical activity and sedentary behaviour
Time frame: Over 3 week period (In the 6 days preceding experimental testing)
Perceived workload
Time frame: Over 3 week period (After 7 days of each intervention). Measured immediately before and after exercise
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 30 Apr 2020.
- Derived from this study: PubMed 33970327Sadler DG, Draijer R, Stewart CE, Jones H, Marwood S, Thijssen DHJ. Cocoa-flavanols enhance moderate-intensity pulmonary V O 2 kinetics but not exercise tolerance in sedentary middle-aged adults. Eur J Appl Physiol. 2021 Aug;121(8):2285-2294. doi: 10.1007/s00421-021-04682-9. Epub 2021 May 10.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cocoa flavanols in people with Aging and Sedentary Behavior, run by Liverpool John Moores University 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 3 inclusion and 10 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 30 Apr 2020. 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. Some participants in this study may receive a placebo. 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?
Oxygen uptake kinetics (time frame: Over 3 week period (After 7 days of each intervention). Oxygen uptake measured for 9 minutes continuously during exercise bouts (3 min warm up period and 6 minutes of exercise transition)). 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 NCT04370353, which also lists 1 linked publication.
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 30 Apr 2020.