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

NCT07024966 | Recruiting

• 1 other identifier: PT-SILAOX
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Oxidative Stress; Physical Activity; Antioxidant Effect

Keywords

Oxidative Stress; High-intensity exercise; Pterostilbene; Antioxidant supplement; Nutraceutical; Crossover trial; Exercise recovery; Nutritional intervention; Polyphenols; Cocrystal

Outcome Measures

Primary Outcomes (1)

• Malondialdehyde (MDA) plasma levels

  Plasma MDA levels will be measured using commercial ELISA kits

  At week 1, week 3, week 4 and week 6.

Secondary Outcomes (29)

• Age

  At week 0 (pre-selection visit)

• Height (cm)

  At week 0 (pre-selection visit)

• Body Weight (Kg)

  At week 0 (pre-selection visit)

• Body Mass Index (BMI) (Kg/m^2)

  At week0 (pre-selection visit)

• Urine 8-hydroxy-2'-deoxyguanosine (8-OHdG) levels

  At week 1, week 3, week 4 and week 6.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants treated with Microcrystalline Cellulose for 14 days

Dietary Supplement: Control Group

ccPT-SIL-NR Group

EXPERIMENTAL

Participants treated with pterostilbene, silybin, and nicotinamide riboside for 14 days

Dietary Supplement: Pterostilbene-silybin-nicotinamide riboside

Interventions

Pterostilbene-silybin-nicotinamide riboside DIETARY_SUPPLEMENT

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

ccPT-SIL-NR Group

Control Group DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male participants between 18 and 50 years of age who are amateur runners.
• Engage in at least 3 continuous running sessions per week, each lasting 60 minutes, which corresponds to a high level of physical activity according to the International Physical Activity Questionnaire (IPAQ).\*
• Self-report being able to continuously run for 45 minutes at high intensity without difficulty.
• Provide signed informed consent prior to participation in the study.
• Able to read, write, and speak either Catalan or Spanish.
• High level of physical activity according to the IPAQ: vigorous physical activity (such as running) on at least 3 days per week, with a total energy expenditure ≥1500 MET-min/week.
• MET value for vigorous activity = 8 × minutes × days per week.

You may not qualify if:

• Body Mass Index (BMI) ≤ 18 kg/m² or ≥ 30 kg/m².
• Presence of chronic diseases associated with increased oxidative stress, such as diabetes, hypertension, chronic obstructive pulmonary disease (COPD), or neurodegenerative diseases.
• Personal history of cardiovascular disease, including myocardial infarction, angina pectoris, stroke, or peripheral artery disease.
• Use of antibiotics within 30 days prior to study entry.
• Use of medications or vitamin supplements that may interfere with the study supplement and exceed 100% of the recommended daily intake within 30 days prior to the start of the study.
• Use of polyphenol supplements, herbal extracts, or phytotherapeutic products that may interfere with the study treatment within 30 days prior to study start.
• Alcohol consumption of 4 or more Standard Drink Units (SDUs) per day or 28 SDUs per week.\*
• \*One SDU is defined as 10 grams of alcohol. This corresponds approximately to: 1 glass of wine (120 mL), 1 beer (330 mL), or 1 small spirit (25 mL); 2 SDUs correspond to 1 glass of brandy or liqueur (55 mL), 1 whiskey (70 mL), or a mixed drink (75 mL).
• Active smoker.
• Unintentional weight loss of more than 3 kg in the past 3 months.
• Known food allergies and/or intolerances related to the study products.
• Presence of anemia.
• Presence of chronic gastrointestinal diseases\* or cancer.\*\*
• \*Chronic gastrointestinal diseases include those in an active phase that may interfere with nutrient absorption. Common examples include gastritis, hiatal hernia, Crohn's disease, celiac disease, irritable bowel syndrome, diverticulitis, diverticulosis, chronic constipation, and ulcerative colitis.
• \*\*Individuals with a history of cancer may be included only if they are in complete remission at the start of the study.

Sponsors & Collaborators

• Fundació Eurecat: lead
• Circe, S.L.: collaborator

Study Sites (1)

Fundació Eurecat

Reus, Tarragona, 43204, Spain

RECRUITING

Related Links

• Technological Centre of Nutrition and Health. Eurecat\_Reus.

MeSH Terms

Conditions

Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Antoni Caimari, PhD

  Fundació Eurecat

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antoni Caimari, PhD

CONTACT

+34 977 300 431; antoni.caimari@eurecat.org

Anna Crescenti, PhD

CONTACT

+34 977 300 431; anna.crescenti@eurecat.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the of the Biotechnology Area

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 17, 2025
• Study Start: August 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)