- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07148726
- Original Trial
EFFECTS OF PYRROLOQUINOLINE QUINONE (PQQ) SUPPLEMENTATION ON NON-ENDURANCE TRAINED ATHLETES
September 2, 2025 updated by: University of Padova
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Italy
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Padua, Italy, Italy, 35131
- Nutrition and Exercise Lab, DSB, University of Padova
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 1) chronic disease;
- 2) acute illness; and
- 3) use of dietary supplements, pharmacological agents, or adherence to a hypocaloric diet.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PQQ GROUP
PQQ supplemented participants will receive 20mg/PQQ die
|
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).
|
|
Placebo Comparator: PLACEBO GROUP
participants will be given a placebo for 36 days
|
Subjects were provided with 84 capsules of placebo.
The indication will be to take two capsules every evening for 6 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2024
Primary Completion (Actual)
August 15, 2025
Study Completion (Actual)
August 15, 2025
Study Registration Dates
First Submitted
August 22, 2025
First Submitted That Met QC Criteria
August 22, 2025
First Posted (Estimated)
August 29, 2025
Study Record Updates
Last Update Posted (Estimated)
September 10, 2025
Last Update Submitted That Met QC Criteria
September 2, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HEC-DSB/05-21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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