Evaluation of Pine Bark Extract for Anti-fatigue Ergogenic Properties

NCT07440394 | Completed

• 1 other identifier: CMUH111-REC2-173
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This research proposal aims to elucidate the physiological responses to pine bark extract supplementation during a single bout of high-intensity cycling exercise at 70% VO₂max and the subsequent recovery phase. Specifically, the study seeks to investigate the underlying mechanisms by which pine bark extract modulates exercise-induced fatigue and metabolic fitness, and to determine whether such supplementation may enhance endurance performance in the post-recovery period.

Conditions

Healthy

Keywords

pine bark extract; exercise performance; Maximal oxygen consumption

Outcome Measures

Primary Outcomes (1)

• Time to Exhaustion (TTE)

  The total duration (in minutes) from the start of the graded exercise test until the participant reaches volitional exhaustion or can no longer maintain the required cadence of 60 RPM. Unit of Measure: Minutes

  Baseline and at the end of the 4-week crossover period.

Secondary Outcomes (19)

• Serum Tumor Necrosis Factor-alpha (TNF-alpha) Concentration

  7 time points (Baseline, START, END, 0 min, 60 min, 120 min, 180 min in two ergometer trials) during each crossover trial.

• Superoxide Dismutase (SOD) Activity

  7 time points (Baseline, START, END, 0 min, 60 min, 120 min, 180 min in two ergometer trials) during each crossover trial.

• Blood Glucose Levels

  7 time points (Baseline, START, END, 0 min, 60 min, 120 min, 180 min in two ergometer trials) during each crossover trial.

• Uric Acid (UA) Levels

  7 time points (Baseline, START, END, 0 min, 60 min, 120 min, 180 min in two ergometer trials) during each crossover trial.

• Lactate Dehydrogenase (LDH) Activity

  7 time points (Baseline, START, END, 0 min, 60 min, 120 min, 180 min in two ergometer trials) during each crossover trial.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Containing edible yellow No. 4, edible yellow No. 5, sucrose, silica, talc, oxidized starch, gelatin, magnesium stearate, and palm wax.

Other: Placebo (Placebo trial); Other: PBE (PBE trial)

PBE

EXPERIMENTAL

Each capsule containing 100 mg of Pycnogenol®, Taiwan

Other: Placebo (Placebo trial); Other: PBE (PBE trial)

Interventions

Placebo (Placebo trial) OTHER

The Placebo capsule supplement was taken for 4 days (3 capsules per day)

PBE; Placebo

PBE (PBE trial) OTHER

The PBE capsule supplement was taken for 4 days, with a daily dosage of 300 mg of PBE (equivalent to 3 capsules per day, each containing 100 mg of PBE).

PBE; Placebo

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• A minimum of three years of regular exercise habits.

You may not qualify if:

• Have smoking and drinking habits.
• People who feel unwell due to other reasons during the experiment.
• Individuals with respiratory disorders.
• Severe lower limb musculoskeletal injuries within the past six months.

Sponsors & Collaborators

• China Medical University Hospital: lead
• National Science and Technology Council, Taiwan: collaborator
• China Medical University, Taiwan: collaborator

Study Sites (1)

China Medical University

Taichung, Taiwan

Location

Study Officials

• Jung-Piao Tsao

  China Medical University, China

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study recruited 14 healthy adult, all of whom engage in regular physical training. Participants were crossed over for Pine bark extract or placebo supplements, which could be ended in two days.

Study Record Dates

• First Submitted: July 27, 2025
• First Posted: February 27, 2026
• Study Start: April 21, 2023
• Primary Completion: October 1, 2023
• Study Completion: December 31, 2023
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)