Oxygen ConsumptionNCT06186297
Boosting Performance: The Power of Cranberry Supplementation
A study testing Cranberry extract in people with Oxygen Consumption and Mitochondria, run by Concordia University, Montreal at 1 site in Canada.
Trial summary
Cranberry is a fruit native to North America that is widely grown in Quebec and has been shown to have the highest antioxidant capacity among the most commonly eaten fruits. Consequently, consuming cranberries prior to exercising may help to improve exercise endurance by preventing accumulation of reactive oxygen… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxygen Consumption, Mitochondria, Blood Flow
- What is being tested?
- Cranberry extract
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2023to 30 Jun 2023
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- recreationally active, healthy and between the ages of 18-35.
Who cannot join
- smoker; use of ergogenic substances or any kind or drugs that could alter the cardiovascular responses; resting BP higher than 140/90 mm Hg; and cardiovascular or metabolic disease (especially hypertension and diabetes)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Cranberry Extract on Muscle Oxygenation and Mitochondrial Health in University Students
Cranberry is a fruit native to North America that is widely grown in Quebec and has been shown to have the highest antioxidant capacity among the most commonly eaten fruits. Consequently, consuming cranberries prior to exercising may help to improve exercise endurance by preventing accumulation of reactive oxygen species. For aerobic endurance, in order to maintain a certain pace for a long duration, runners need to effectively neutralize reactive oxygen species. Although it is not the only component involved in running, offsetting reactive oxygen species should improve running performance.
To test this, we plan to investigate the effects, both acute and chronic, of a cranberry extract on the oxygen consumption in 18-35 year old males and females.
The present research project will contribute to expand our knowledge of how cranberry extract can exert a positive effect, and thus improve aerobic performance or even every day life. This project can benefit a wide range of the population, from sedentary individuals and older adults to elite athletes by providing an all-natural supplement alternative.
Read the detailed description
Each participant will be involved in the study for a period of 5 weeks, during which they will commit to 3 visits:
The first visit (on week 1) will be to obtain baseline measurements. During the second visit (on week 2), acute effects of the cranberry extract will be evaluated by giving a single high dose to the participants 1 hour before the trial events. The third visit (on week 5) will be to evaluate the chronic effects of the cranberry extract after 4 weeks of daily consumption. We will use the following instruments to gather data:
- Questionnaires (height, weight, dietary patterns, to determine training level, past injuries, single or multisport athlete etc.)
- Continuous wavelength NIRS will be used to measure oxygen levels in the quadriceps using portable Moxy monitors. For this test the subjects will be wearing the portable and convenient oxygen monitors taped firmly on the appropriate muscles. NIRS is a non-invasive method and measures the level of oxygenation in the muscle tissues by sending near-infrared light through the skin, which travels through the muscle fibers and is then recovered and returned to the surface of the skin and into the back of the sensor. As light moves through the skin layers (skin, fat and muscle), it scatters, and it identifies the oxygenated and the deoxygenated blood cells due to their colors. The blood cells identified are hemoglobin and myoglobin cells.
For the actual test, the quadriceps will be activated using electrical twitch stimulation at either 4 or 6Hz for 30 s at a current level that produce vigorous but submaximal contractions. During the contraction, the NIRS will be used in combination with short duration ischemic cuff periods (200 mmHg) applied by a Hokanson rapid cuff inflator. By repeating 5 second occlusion followed by 5 second deflation 6 times, at the same time as we activate the muscle, we will be able to determine muscle metabolism (mitochondrial oxygen consumption) by using the rate constant of the recovery from high to low metabolic rate.
- Skinfold measurement of the placement area for the Moxy oxygen monitors to determine if the light can penetrate subcutaneous tissues (has to be <15mm)
- Conditions
- Oxygen Consumption, Mitochondria, Blood Flow, Aerobic Capacity
- Being tested
- Cranberry extract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranberry extractDietary supplement
polyphenol PAC-1
| Study group | Role | What they receive |
|---|---|---|
| Cranberry extract | Experimental | Not described Receives: Dietary Supplement: Cranberry extract |
| Baseline | Active comparator | Not described Receives: Dietary Supplement: Cranberry extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen consumption
Measured: 20 minutes
Secondary outcomes (1)
Blood flow
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start1 Mar 2023
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxygen ConsumptionStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Concordia University, Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Bergdahl, Concordia University, Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186297
- Sponsor's protocol ID
- 30017882
- Status last verified
- Dec 2023
- First submitted
- 15 Dec 2023
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Cranberry Extract on Muscle Oxygenation and Mitochondrial Health in University Students
- ClinicalTrials.gov ID
- NCT06186297
- Acronym / sponsor ID
- 30017882
- Conditions
- Oxygen Consumption, Mitochondria, Blood Flow, Aerobic Capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Concordia University, MontrealUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 2 Jan 2024 (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.
Cranberry is a fruit native to North America that is widely grown in Quebec and has been shown to have the highest antioxidant capacity among the most commonly eaten fruits. Consequently, consuming cranberries prior to exercising may help to improve exercise endurance by preventing accumulation of reactive oxygen species. For aerobic endurance, in order to maintain a certain pace for a long duration, runners need to effectively neutralize reactive oxygen species. Although it is not the only component involved in running, offsetting reactive oxygen species should improve running performance.
To test this, we plan to investigate the effects, both acute and chronic, of a cranberry extract on the oxygen consumption in 18-35 year old males and females.
The present research project will contribute to expand our knowledge of how cranberry extract can exert a positive effect, and thus improve aerobic performance or even every day life. This project can benefit a wide range of the population, from sedentary individuals and older adults to elite athletes by providing an all-natural supplement alternative.
Detailed description
Each participant will be involved in the study for a period of 5 weeks, during which they will commit to 3 visits:
The first visit (on week 1) will be to obtain baseline measurements. During the second visit (on week 2), acute effects of the cranberry extract will be evaluated by giving a single high dose to the participants 1 hour before the trial events. The third visit (on week 5) will be to evaluate the chronic effects of the cranberry extract after 4 weeks of daily consumption. We will use the following instruments to gather data:
- Questionnaires (height, weight, dietary patterns, to determine training level, past injuries, single or multisport athlete etc.)
- Continuous wavelength NIRS will be used to measure oxygen levels in the quadriceps using portable Moxy monitors. For this test the subjects will be wearing the portable and convenient oxygen monitors taped firmly on the appropriate muscles. NIRS is a non-invasive method and measures the level of oxygenation in the muscle tissues by sending near-infrared light through the skin, which travels through the muscle fibers and is then recovered and returned to the surface of the skin and into the back of the sensor. As light moves through the skin layers (skin, fat and muscle), it scatters, and it identifies the oxygenated and the deoxygenated blood cells due to their colors. The blood cells identified are hemoglobin and myoglobin cells.
For the actual test, the quadriceps will be activated using electrical twitch stimulation at either 4 or 6Hz for 30 s at a current level that produce vigorous but submaximal contractions. During the contraction, the NIRS will be used in combination with short duration ischemic cuff periods (200 mmHg) applied by a Hokanson rapid cuff inflator. By repeating 5 second occlusion followed by 5 second deflation 6 times, at the same time as we activate the muscle, we will be able to determine muscle metabolism (mitochondrial oxygen consumption) by using the rate constant of the recovery from high to low metabolic rate.
- Skinfold measurement of the placement area for the Moxy oxygen monitors to determine if the light can penetrate subcutaneous tissues (has to be <15mm)
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cranberry extract | Experimental | Dietary Supplement: Cranberry extract |
| Baseline | Active comparator | Dietary Supplement: Cranberry extract |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- recreationally active, healthy and between the ages of 18-35.
Key exclusion criteria (1 listed)
- smoker; use of ergogenic substances or any kind or drugs that could alter the cardiovascular responses; resting BP higher than 140/90 mm Hg; and cardiovascular or metabolic disease (especially hypertension and diabetes)
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 |
|---|---|---|
| Cranberry extractpolyphenol PAC-1 | Dietary supplement | Baseline, Cranberry extract |
Primary outcome
Oxygen consumption
Time frame: 20 minutes
1 secondary outcome
Blood flow
Time frame: 20 minutes
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 2 Jan 2024.
- Individual participant dataSharing planned: No
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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 Cranberry extract in people with Oxygen Consumption and Mitochondria, run by Concordia University, Montreal at 1 site in Canada.
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 1 inclusion and 1 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 2 Jan 2024. 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 Canada. 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?
Oxygen consumption (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jan 2024.