Mitochondrial BiogenesisNCT07148726
EFFECTS OF PYRROLOQUINOLINE QUINONE (PQQ) SUPPLEMENTATION ON NON-ENDURANCE TRAINED ATHLETES
A study testing Pyrrole Quinoline Quinone (PQQ) in people with Mitochondrial Biogenesis and Inflammation, run by University of Padova at 1 site in Italy.
Trial summary
The aim of this study was to investigate the effects of six weeks of PQQ supplementation in non-endurance-trained individuals on: 1. physiological and metabolic response during a FATmax-VO₂peak exercise test 2. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Mitochondrial Biogenesis, Inflammation
- What is being tested?
- Pyrrole Quinoline Quinone (PQQ)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2024to 15 Aug 2025
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1) Age: Participants aged between 18 and 40 years.
- 2) Body mass index (BMI): BMI within the range of 18-30 kg/m².
- 4) Physical activity: Regular engagement in non-endurance physical activities (3-4 times a week), with no participation in structured endurance training programs.
Who cannot join
- 1) chronic disease;
- 2) acute illness; and
- 3) use of dietary supplements, pharmacological agents, or adherence to a hypocaloric diet.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Nutrition and Exercise Lab, DSB, University of Padova
Padova, Italy, 35131
About this study
Official title: EFFECTS OF PYRROLOQUINOLINE QUINONE (PQQ) SUPPLEMENTATION ON METABOLIC AND PHYSIOLOGICAL ADAPTATION AT REST AND DURING SUBMAXIMAL EXERCISE IN NON-ENDURANCE-TRAINED ATHLETES: A RANDOMIZED PLACEBO-CONTROLLED TRIAL
The aim of this study was to investigate the effects of six weeks of PQQ supplementation in non-endurance-trained individuals on:
- physiological and metabolic response during a FATmax-VO₂peak exercise test
- resting energy expenditure, body composition and blood biomarkers (fasting glucose, lactate dehydrogenase (LDH), creatine phosphokinase (CPK) and C-reactive protein (CRP) levels)
- blood and urine omics markers of oxidative metabolism 24 basketball players will be randomized to consume a supplement containing 20 mg/day of PQQ or placebo (PLA) during a six-week intervention. Subjects will be encouraged to maintain their usual diet and training schedule. Body composition will be assessed by dual-energy-x-ray-absorptiometry and bioimpedance analysis. Aerobic exercise performance will be evaluated through a graded exercise protocol (six 5-minutes steps followed by n 2-minutes steps until exhaustion; the initial workload was 60 watts and increased by 35 watts at the end of each step) performed on a cycle ergometer. Capillary blood lactate samples were collected at the end of each step. Blood and urine samples were also collected, and metabolomics analysis will be performed.
- Conditions
- Mitochondrial Biogenesis, Inflammation
- Being tested
- Pyrrole Quinoline Quinone (PQQ), Placebo
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyrrole Quinoline Quinone (PQQ)Dietary supplement
Subjects will be provided with 84 capsules of the PQQ or the placebo supplement. Both supplements were in capsule form and identical in size, shape and color. The PQQ content per capsule was 10 mg. The indication was to take two capsules every evening for 6 weeks. The duration of the supplementation protocol was assessed based on a previous study (Hwang et al., 2020), while the dose was chosen according to EFSA recommendations (Turck et al., 2017).
PlaceboOther
Subjects were provided with 84 capsules of placebo. The indication will be to take two capsules every evening for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| PQQ GROUP | Experimental | PQQ supplemented participants will receive 20mg/PQQ die Receives: Dietary Supplement: Pyrrole Quinoline Quinone (PQQ) |
| PLACEBO GROUP | Placebo comparator | participants will be given a placebo for 36 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat oxidation during FATmax-VO₂peak exercise test using gas analyzer.
Participants perform a graded exercise test on an electronically braked bicycle ergometer. A modified FATmax protocol is employed. After a 10-min warm-up at 50 W, the test commenced at 60 W and the workload increased by 35 W every 5 min until the participant could no longer maintain a cadence ≥60 rpm. The volume of Oxygen uptake (VO₂) and carbon dioxide production (VCO₂) per minute were recorded via a breath-by-breath gas analyzer. The average V̇O2 and V̇CO2 is extracted over the final 2 min of each stage of the test to ensure steady-state values . FatAT and carbohydrate (CHO) CHO oxidation and energy expenditure are calculated via stoichiometric equations (Jeukendrup \& Wallis, 2005) and appropriate energy equivalents, with the assumption that the urinary nitrogen excretion rate was negligible. Data are analyzed workload-matched
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start1 Sep 2024
- Primary completion15 Aug 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitochondrial BiogenesisStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07148726
- Sponsor's protocol ID
- HEC-DSB/05-21
- Status last verified
- Jul 2025
- First submitted
- 22 Aug 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF PYRROLOQUINOLINE QUINONE (PQQ) SUPPLEMENTATION ON METABOLIC AND PHYSIOLOGICAL ADAPTATION AT REST AND DURING SUBMAXIMAL EXERCISE IN NON-ENDURANCE-TRAINED ATHLETES: A RANDOMIZED PLACEBO-CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT07148726
- Acronym / sponsor ID
- HEC-DSB/05-21
- Conditions
- Mitochondrial Biogenesis, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 29 Aug 2025 (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.
The aim of this study was to investigate the effects of six weeks of PQQ supplementation in non-endurance-trained individuals on:
- physiological and metabolic response during a FATmax-VO₂peak exercise test
- resting energy expenditure, body composition and blood biomarkers (fasting glucose, lactate dehydrogenase (LDH), creatine phosphokinase (CPK) and C-reactive protein (CRP) levels)
- blood and urine omics markers of oxidative metabolism 24 basketball players will be randomized to consume a supplement containing 20 mg/day of PQQ or placebo (PLA) during a six-week intervention. Subjects will be encouraged to maintain their usual diet and training schedule. Body composition will be assessed by dual-energy-x-ray-absorptiometry and bioimpedance analysis. Aerobic exercise performance will be evaluated through a graded exercise protocol (six 5-minutes steps followed by n 2-minutes steps until exhaustion; the initial workload was 60 watts and increased by 35 watts at the end of each step) performed on a cycle ergometer. Capillary blood lactate samples were collected at the end of each step. Blood and urine samples were also collected, and metabolomics analysis will be performed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PQQ GROUP | Experimental | Dietary Supplement: Pyrrole Quinoline Quinone (PQQ)PQQ supplemented participants will receive 20mg/PQQ die |
| PLACEBO GROUP | Placebo comparator | Other: Placeboparticipants will be given a placebo for 36 days |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 1) Age: Participants aged between 18 and 40 years.
- 2) Body mass index (BMI): BMI within the range of 18-30 kg/m².
- 4) Physical activity: Regular engagement in non-endurance physical activities (3-4 times a week), with no participation in structured endurance training programs.
Key exclusion criteria (3 listed)
- 1) chronic disease;
- 2) acute illness; and
- 3) use of dietary supplements, pharmacological agents, or adherence to a hypocaloric diet.
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 |
|---|---|---|
| Pyrrole Quinoline Quinone (PQQ)Subjects will be provided with 84 capsules of the PQQ or the placebo supplement. Both supplements were in capsule form and identical in size, shape and color. The PQQ content per capsule was 10 mg. The indication was to take two capsules every evening for 6 weeks. The duration of the supplementation protocol was assessed based on a previous study (Hwang et al., 2020), while the dose was chosen according to EFSA recommendations (Turck et al., 2017). | Dietary supplement | PQQ GROUP |
| PlaceboSubjects were provided with 84 capsules of placebo. The indication will be to take two capsules every evening for 6 weeks. | Other | PLACEBO GROUP |
Primary outcome
Fat oxidation during FATmax-VO₂peak exercise test using gas analyzer.
Time frame: 6 weeks
Participants perform a graded exercise test on an electronically braked bicycle ergometer. A modified FATmax protocol is employed. After a 10-min warm-up at 50 W, the test commenced at 60 W and the workload increased by 35 W every 5 min until the participant could no longer maintain a cadence ≥60 rpm. The volume of Oxygen uptake (VO₂) and carbon dioxide production (VCO₂) per minute were recorded via a breath-by-breath gas analyzer. The average V̇O2 and V̇CO2 is extracted over the final 2 min of each stage of the test to ensure steady-state values . FatAT and carbohydrate (CHO) CHO oxidation and energy expenditure are calculated via stoichiometric equations (Jeukendrup \& Wallis, 2005) and appropriate energy equivalents, with the assumption that the urinary nitrogen excretion rate was negligible. Data are analyzed workload-matched
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 10 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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 Pyrrole Quinoline Quinone (PQQ) in people with Mitochondrial Biogenesis and Inflammation, run by University of Padova at 1 site in Italy.
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 3 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 10 Sep 2025. 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 Italy. 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?
Fat oxidation during FATmax-VO₂peak exercise test using gas analyzer. (time frame: 6 weeks). 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 10 Sep 2025.