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Effect of the Combination of Pterostilbene Cocrystal With Silybin and Nicotinamide Riboside on Exercise-Induced Oxidative Stress

NCT07024966 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-08-27

No results posted yet for this study

Summary

This study aims to evaluate the effects of the dietary supplement ccPT-SIL-NR, which contains pterostilbene (ccPT), silybin (SIL), and nicotinamide riboside (NR), on oxidative stress markers after a high-intensity exercise session. The primary objective is to assess changes in blood malondialdehyde (MDA) levels.

Secondary objectives include evaluating the effects on oxidative DNA damage (8-OHdG), lipid peroxidation (F2-isoprostanes), total antioxidant capacity (FRAP assay), glutathione ratio (GSH/GSSG), antioxidant enzyme activity (SOD, CAT, GPx), inflammatory markers (hsCRP, MCP-1, IL-6), muscle damage markers (LDH, CK), cortisol levels, renal function (creatinine), and gene expression patterns through transcriptomic analysis.

The study will include 14 healthy male participants in a randomized, tripple-blind, placebo-controlled, crossover design. Each participant will receive both the ccPT-SIL-NR supplement and placebo for 14 days each, separated by a washout period of at least one week. A high-intensity exercise test will be performed at the end of each supplementation period. Total study duration per participant will be a minimum of 6 weeks.

Conditions

  • Oxidative Stress
  • Physical Activity
  • Antioxidant Effect

Interventions

DIETARY_SUPPLEMENT

Pterostilbene-silybin-nicotinamide riboside

Participants will take 2 sachets, each containing 340 mg of ccPT, silybin and nicotinamide riboside, and 1.91 g of excipients.

DIETARY_SUPPLEMENT

Control Group

Participants will take 2 sachets, each containing 340 mg microcrystalline cellulose, and 1.91 g of excipients.

Sponsors & Collaborators

  • Circe, S.L.

    collaborator UNKNOWN

  • Fundació Eurecat

    lead OTHER

Principal Investigators

  • Antoni Caimari, PhD · Fundació Eurecat

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2025-11-30
Completion
2025-11-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07024966 on ClinicalTrials.gov