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:

  1. physiological and metabolic response during a FATmax-VO₂peak exercise test
  2. resting energy expenditure, body composition and blood biomarkers (fasting glucose, lactate dehydrogenase (LDH), creatine phosphokinase (CPK) and C-reactive protein (CRP) levels)
  3. 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Italy
    • Italy
      • Padua, Italy, Italy, 35131
        • Nutrition and Exercise Lab, DSB, University of Padova

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PQQ GROUP
PQQ supplemented participants will receive 20mg/PQQ die
Dietary supplement: 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).
Placebo Comparator: PLACEBO GROUP
participants will be given a placebo for 36 days
Other: Placebo
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Padova

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 29, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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