Physiologic ChangesNCT07872111
Chrysin Exercise Performance Pilot Study
A study testing Chrysin LipoMicel in people with Physiologic Changes and Exercise, run by Isura at 1 site in Canada.
Trial summary
This single-arm pilot study evaluates within-subject changes in aerobic capacity, heart rate responses, cycling power output, and related physiological measures in healthy adults during and after 30 days of supplementation with a chrysin-based multi-flavonoid LipoMicel formulation containing chrysin, quercetin, and… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Physiologic Changes, Exercise, Physiological Changes (Heart Rate)
- What is being tested?
- Chrysin LipoMicel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 5 Jan 2025to 17 Jul 2026
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female adults aged 18-45 years
- BMI between 18.5 and 30 kg/m²
- Low-active or recreationally active/untrained individuals, defined as not participating in structured endurance or resistance training
- Able and willing to complete maximal or incremental indoor cycling-based exercise testing
- Willing to maintain usual diet, physical activity habits, and supplement routines throughout the study
- Able to provide written informed consent
Who cannot join
- History or presence of cardiovascular disease or other chronic disease that could affect study participation
- Existing musculoskeletal injury or inflammatory condition that could interfere with exercise testing
- Use of prescription medications or other agents that may affect cardiovascular function, metabolic function, inflammation, or exercise performance Pregnancy
- Any condition that, in the investigator's opinion, would preclude safe participation in maximal exercise testing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Single-Arm Study of a Micellar Chrysin-Based Multi-Flavonoid Formulation and Exercise-Related Physiological Responses in Healthy Adults
This single-arm pilot study evaluates within-subject changes in aerobic capacity, heart rate responses, cycling power output, and related physiological measures in healthy adults during and after 30 days of supplementation with a chrysin-based multi-flavonoid LipoMicel formulation containing chrysin, quercetin, and rutin.
- Being tested
- Chrysin LipoMicel
- Keywords
- exercise, physiology, VO2max, heart rate, zone 2, power output, polyphenols, chrysin, dietary supplements, natural health products, Quercetin, Rutin, LipoMicel, flavonoids, bioavailability
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chrysin LipoMicelDietary supplement
A maximum oral dose of 1000mg chrysin.
| Study group | Role | What they receive |
|---|---|---|
| Chrysin LipoMicel | Experimental | Each participant received a daily dose of a micellar chrysin-based multi-flavonoid formulation once daily for 30 days, providing a total daily dose of 1000 mg chrysin, 240 mg quercetin, and 230 mg rutin. On study visit days participants were instructed to take the intervention after completing a cardiopulmonary exercise testing sessions. No specific instructions were given regarding intake with or without food. Physiological assessments were performed at each study visit. Receives: Dietary Supplement: Chrysin LipoMicel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximal oxygen uptake (VO2max)
VO₂max assessed during standardized incremental indoor cycling-based cardiopulmonary exercise testing. VO₂max is defined as the highest step-averaged oxygen uptake value achieved during the incremental cycling test.
Measured: Day -7, 0, 14, 31, 45
Change in maximum heart rate (HRmax)
To assess within-subject changes in maximum heart rate, defined as the highest heart rate recorded during the standardized incremental cycling test, in healthy adult volunteers receiving the chrysin-based LipoMicel formulation.
Measured: Day -7, 0, 14, 31, 45
Zone 2 heart rate (Zone 2 HR)
To assess changes in Zone 2 heart rate, defined as the heart rate corresponding to approximately 60-70% of individual HRmax during standardized incremental cycling testing.
Measured: Day -7, 0, 14, 31, 45
Maximum cycling power output (Max Power)
To assess changes in maximum cycling power output, defined as the highest power output in watts successfully completed during standardized incremental cycling testing.
Measured: Day -7, 0, 14, 31, 45
Secondary outcomes (1)
Change in maximal minute ventilation (Max Ve)
To assess within-subject changes in maximal minute ventilation, defined as the highest minute ventilation recorded during the standardized incremental cycling test, in healthy adult volunteers receiving the chrysin-based LipoMicel formulation.
Measured: Day -7, 0, 14, 31, 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start5 Jan 2025
- Primary completion29 Oct 2025
- Study completion17 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiologic ChangesStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants complete a pre-intervention familiarization and physiological assessment visit on Day -7. Dosing with Chrysin LipoMicel begins on Day 0 and continues once daily for 30 days. Indoor cycling-based physiological fitness assessments are performed at baseline, during supplementation, at the end of supplementation, and at post-supplementation follow-up.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isura
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julia Solnier, PhD, Principal investigator, Isura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07872111
- Sponsor's protocol ID
- 2022-11-002CRVO2
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 13 Oct 2026
- 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Single-Arm Study of a Micellar Chrysin-Based Multi-Flavonoid Formulation and Exercise-Related Physiological Responses in Healthy Adults
- ClinicalTrials.gov ID
- NCT07872111
- Acronym / sponsor ID
- 2022-11-002CRVO2
- Keywords
- exercise, physiology, VO2max, heart rate, zone 2, power output, polyphenols, chrysin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- IsuraUniversity, hospital or other
- Study start
- 5 Jan 2025 (actual)
- Primary completion
- 29 Oct 2025 (actual)
- Study completion
- 17 Jul 2026 (actual)
- First posted
- 13 Oct 2026 (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.
This single-arm pilot study evaluates within-subject changes in aerobic capacity, heart rate responses, cycling power output, and related physiological measures in healthy adults during and after 30 days of supplementation with a chrysin-based multi-flavonoid LipoMicel formulation containing chrysin, quercetin, and rutin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants complete a pre-intervention familiarization and physiological assessment visit on Day -7. Dosing with Chrysin LipoMicel begins on Day 0 and continues once daily for 30 days. Indoor cycling-based physiological fitness assessments are performed at baseline, during supplementation, at the end of supplementation, and at post-supplementation follow-up.
| Arm | Type | Receives |
|---|---|---|
| Chrysin LipoMicel | Experimental | Dietary Supplement: Chrysin LipoMicelEach participant received a daily dose of a micellar chrysin-based multi-flavonoid formulation once daily for 30 days, providing a total daily dose of 1000 mg chrysin, 240 mg quercetin, and 230 mg rutin. On study visit days participants were instructed to take the intervention after completing a cardiopulmonary exercise testing sessions. No specific instructions were given regarding intake with or without food. Physiological assessments were performed at each study visit. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy male or female adults aged 18-45 years
- BMI between 18.5 and 30 kg/m²
- Low-active or recreationally active/untrained individuals, defined as not participating in structured endurance or resistance training
- Able and willing to complete maximal or incremental indoor cycling-based exercise testing
- Willing to maintain usual diet, physical activity habits, and supplement routines throughout the study
Key exclusion criteria (4 listed)
- History or presence of cardiovascular disease or other chronic disease that could affect study participation
- Existing musculoskeletal injury or inflammatory condition that could interfere with exercise testing
- Use of prescription medications or other agents that may affect cardiovascular function, metabolic function, inflammation, or exercise performance Pregnancy
- Any condition that, in the investigator's opinion, would preclude safe participation in maximal exercise testing
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 |
|---|---|---|
| Chrysin LipoMicelA maximum oral dose of 1000mg chrysin. | Dietary supplement | Chrysin LipoMicel |
Primary outcome
Change in maximal oxygen uptake (VO2max)
Time frame: Day -7, 0, 14, 31, 45
VO₂max assessed during standardized incremental indoor cycling-based cardiopulmonary exercise testing. VO₂max is defined as the highest step-averaged oxygen uptake value achieved during the incremental cycling test.
Change in maximum heart rate (HRmax)
Time frame: Day -7, 0, 14, 31, 45
To assess within-subject changes in maximum heart rate, defined as the highest heart rate recorded during the standardized incremental cycling test, in healthy adult volunteers receiving the chrysin-based LipoMicel formulation.
Zone 2 heart rate (Zone 2 HR)
Time frame: Day -7, 0, 14, 31, 45
To assess changes in Zone 2 heart rate, defined as the heart rate corresponding to approximately 60-70% of individual HRmax during standardized incremental cycling testing.
Maximum cycling power output (Max Power)
Time frame: Day -7, 0, 14, 31, 45
To assess changes in maximum cycling power output, defined as the highest power output in watts successfully completed during standardized incremental cycling testing.
1 secondary outcome
Change in maximal minute ventilation (Max Ve)
Time frame: Day -7, 0, 14, 31, 45
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 13 Oct 2026.
- 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.
Julia Solnier, PhD principal investigator
Isura
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chrysin LipoMicel in people with Physiologic Changes and Exercise, run by Isura 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 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 13 Oct 2026. 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?
Change in maximal oxygen uptake (VO2max) (time frame: Day -7, 0, 14, 31, 45). The study lists 4 primary outcomes in all. 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 13 Oct 2026.