NCT07148726

Brief Summary

The aim of this study was to investigate the effects of six weeks of PQQ supplementation in non-endurance-trained individuals on:

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 29, 2025

Completed
Last Updated

September 10, 2025

Status Verified

July 1, 2025

Enrollment Period

12 months

First QC Date

August 22, 2025

Last Update Submit

September 2, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    6 weeks

Study Arms (2)

PQQ GROUP

EXPERIMENTAL

PQQ supplemented participants will receive 20mg/PQQ die

Dietary Supplement: Pyrrole Quinoline Quinone (PQQ)

PLACEBO GROUP

PLACEBO COMPARATOR

participants will be given a placebo for 36 days

Other: Placebo

Interventions

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).

PQQ GROUP
PlaceboOTHER

Subjects were provided with 84 capsules of placebo. The indication will be to take two capsules every evening for 6 weeks.

PLACEBO GROUP

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \) Age: Participants aged between 18 and 40 years.
  • \) Body mass index (BMI): BMI within the range of 18-30 kg/m².
  • \) Physical activity: Regular engagement in non-endurance physical activities (3-4 times a week), with no participation in structured endurance training programs.

You may not qualify if:

  • \) chronic disease;
  • \) acute illness; and
  • \) use of dietary supplements, pharmacological agents, or adherence to a hypocaloric diet.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nutrition and Exercise Lab, DSB, University of Padova

Padua, Italy, 35131, Italy

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2025

First Posted

August 29, 2025

Study Start

September 1, 2024

Primary Completion

August 15, 2025

Study Completion

August 15, 2025

Last Updated

September 10, 2025

Record last verified: 2025-07

Locations