Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-01-01 @ 7:23 AM
Study NCT ID:
NCT07024966
Status:
RECRUITING
Last Update Posted:
2025-08-27
First Post:
2025-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of the Combination of Pterostilbene Cocrystal With Silybin and Nicotinamide Riboside on Exercise-Induced Oxidative Stress
Sponsor:
Fundació Eurecat
Organization:
Study Overview
Official Title:
Effect of the Combination of Pterostilbene Cocrystal With Silybin and Nicotinamide Riboside on High-Intensity Exercise-Induced Oxidative Stress: A Randomized, Crossover, Placebo-Controlled, Triple-Blind Study
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PT-SILAOX
Brief 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.
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.
Detailed Description:
This study aims to evaluate the effect of a nutritional supplement combining pterostilbene, silybin, and nicotinamide riboside on oxidative stress induced by high-intensity exercise. Oxidative stress occurs when there is an imbalance between the production of reactive oxygen species and the body's ability to counteract their harmful effects. High-intensity physical activity is known to increase oxidative stress, potentially leading to cellular damage and inflammation. The supplement under investigation has shown antioxidant properties in preclinical models, and this trial seeks to explore its efficacy in humans. The trial is a randomized, triple-blind, placebo-controlled, and crossover study. Fourteen healthy, physically active men aged 18-50 will be recruited. Each participant will take either the supplement or placebo twice daily for 14 days, followed by a treadmill exercise session at 80% of their VO₂ max. After a washout period, participants will switch treatments and repeat the protocol. Blood and urine samples will be collected both at baseline (prior to supplement intake and without any physical activity) and after the exercise test to evaluate markers of oxidative stress, inflammation, muscle damage, and antioxidant capacity. The main outcome is the change in plasma levels of malondialdehyde (MDA). Secondary outcomes include urinary 8-OHdG and F2-isoprostanes, antioxidant enzyme activities, cortisol levels, and gene expression profiles. This study will help to determine whether the supplement can mitigate exercise-induced oxidative stress and support recovery in recreational athletes.
Participants will attend seven in-person visits:
* V0; week 0 (Screening): Informed consent, eligibility check, medical history, anthropometry.
* V1; week 1 (Baseline 1): Pre-intervention samples collection, supplement/placebo dispensation.
* V2; week 1: Exercise test to determine VO₂ max.
* V3; week 3: First treadmill session after 14 days of intervention with the supplement or placebo, blood draw.
* V4; week 3: Urine sample drop-off post-exercise (0-3h and 3-24h).
* V5; week 4 (Baseline 2): Pre-second intervention samples, crossover begins.
* V6; week 6: Second treadmill session, blood draw.
* V7; week 6: Final urine collection post-exercise (0-3h and 3-24h)..
Participants will attend seven in-person visits:
* V0; week 0 (Screening): Informed consent, eligibility check, medical history, anthropometry.
* V1; week 1 (Baseline 1): Pre-intervention samples collection, supplement/placebo dispensation.
* V2; week 1: Exercise test to determine VO₂ max.
* V3; week 3: First treadmill session after 14 days of intervention with the supplement or placebo, blood draw.
* V4; week 3: Urine sample drop-off post-exercise (0-3h and 3-24h).
* V5; week 4 (Baseline 2): Pre-second intervention samples, crossover begins.
* V6; week 6: Second treadmill session, blood draw.
* V7; week 6: Final urine collection post-exercise (0-3h and 3-24h)..
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: