Oxidative StressPT-SILAOXNCT07024966
Effect of the Combination of Pterostilbene Cocrystal With Silybin and Nicotinamide Riboside on Exercise-Induced Oxidative Stress
A study testing Pterostilbene-silybin-nicotinamide riboside in people with Oxidative Stress and Physical Activity, run by Fundació Eurecat at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress, Physical Activity, Antioxidant Effect
- What is being tested?
- Pterostilbene-silybin-nicotinamide riboside
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2025to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
- Participation in another drug clinical trial or nutritional intervention study within 30 days prior to study inclusion.
- Inability to follow the study guidelines.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Fundació Eurecat
Reus, Tarragona, 43204
Antoni Caimari, PhD, +34 977 300 431 ext. 4814, antoni.caimari@eurecat.org
About this study
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
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.
Read the 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)..
- Conditions
- Oxidative Stress, Physical Activity, Antioxidant Effect
- Being tested
- Pterostilbene-silybin-nicotinamide riboside, Control Group
- Keywords
- Oxidative Stress, High-intensity exercise, Pterostilbene, Antioxidant supplement, Nutraceutical, Crossover trial, Exercise recovery, Nutritional intervention, Polyphenols, Cocrystal
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pterostilbene-silybin-nicotinamide ribosideDietary supplement
Participants will take 2 sachets, each containing 340 mg of ccPT, silybin and nicotinamide riboside, and 1.91 g of excipients.
Control GroupDietary supplement
Participants will take 2 sachets, each containing 340 mg microcrystalline cellulose, and 1.91 g of excipients.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants treated with Microcrystalline Cellulose for 14 days Receives: Dietary Supplement: Control Group |
| ccPT-SIL-NR Group | Experimental | Participants treated with pterostilbene, silybin, and nicotinamide riboside for 14 days Receives: Dietary Supplement: Pterostilbene-silybin-nicotinamide riboside |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malondialdehyde (MDA) plasma levels
Plasma MDA levels will be measured using commercial ELISA kits
Measured: At week 1, week 3, week 4 and week 6.
Secondary outcomes (29)
Age
The age of the volunteers will be recorded in the case report form.
Measured: At week 0 (pre-selection visit)
Height (cm)
Height measured with standardized method
Measured: At week 0 (pre-selection visit)
Body Weight (Kg)
Weight measured using the InBody 970 device
Measured: At week 0 (pre-selection visit)
Body Mass Index (BMI) (Kg/m^2)
Weight and height will be combined to report BMI in kg/m^2
Measured: At week0 (pre-selection visit)
Urine 8-hydroxy-2'-deoxyguanosine (8-OHdG) levels
Urine 8-OHdG levels will be measured using commercial ELISA kits
Measured: At week 1, week 3, week 4 and week 6.
Urine F2-isoprostanes levels
Urine F2-isoprostanes levels will be measured using commercial ELISA kits
Measured: At week 1, week 3, week 4 and week 6.
Plasma antioxidant capacity
Plasma antioxidant capacity will be measured by the Ferric Reducing Antioxidant Power assay using ELISA kits.
Measured: At week 1, week 3, week 4 and week 6.
Erythrocyte Redox Status (GSH/GSSG Ratio)
The ratio of reduced glutathione (GSH) to oxidized glutathione (GSSG) will be measured in erythrocytes using commercial ELISA kits.
Measured: At week 1, week 3, week 4 and week 6.
Superoxide Dismutase (SOD) Activity
Serum levels of superoxide dismutase (SOD) activity will be measured using a commercial ELISA kit.
Measured: At week 1, week 3, week 4 and week 6.
Catalase (CAT) Activity
Serum catalase (CAT) activity will be measured using a commercial ELISA kit.
Measured: At week 1, week 3, week 4 and week 6.
Glutathione Peroxidase (GPx) Activity
Serum levels of glutathione peroxidase (GPx) activity will be measured using a commercial ELISA kit.
Measured: At week 1, week 3, week 4 and week 6.
Serum High-Sensitivity C-Reactive Protein (hs-CRP) Levels
Serum levels of high-sensitivity C-reactive protein (hs-CRP) will be measured using turbidimetric methods.
Measured: At week 1, week 3, week 4 and week 6.
Plasma Monocyte Chemoattractant Protein-1 (MCP-1) Levels
Plasma levels of monocyte chemoattractant protein-1 (MCP-1) will be measured using a commercial multiplex Cytometric Bead Array kit.
Measured: At week 1, week 3, week 4 and week 6.
Plasma Interleukin-6 (IL-6) Levels
Plasma levels of interleukin-6 (IL-6) will be measured using a commercial multiplex Cytometric Bead Array kit.
Measured: At week 1, week 3, week 4 and week 6.
Plasma Lactate Dehydrogenase (LDH) Levels
Plasma levels of lactate dehydrogenase (LDH) will be measured using commercial ELISA kits.
Measured: At week 1, week 3, week 4 and week 6.
Plasma Creatine Kinase (CK) Levels
Plasma levels of creatine kinase (CK) will be measured using commercial ELISA kits
Measured: At week 1, week 3, week 4 and week 6.
Serum Cortisol Levels
Serum cortisol levels will be determined using electrochemiluminescence methods.
Measured: At week 1, week 3, week 4 and week 6.
Urinary Creatinine Levels
Urinary creatinine levels will be measured using a commercial ELISA kit
Measured: At week 1, week 3, week 4 and week 6.
Maximal Oxygen Uptake (VO₂ max)
VO₂ max. be assessed through a graded exercise test. This data will be used to calibrate subsequent treadmill sessions at 80% of each participant's VO₂ max.
Measured: At week 1.
Heart Rate, Treadmill Speed and Incline
Heart rate, treadmill speed, and incline at the intensity of 80% of each participant's VO₂ max. will be recorded in the case report form.
Measured: At week 1.
Physical Activity Level (Questionnaire-Based)
Physical activity level will be assessed using the "Quick Physical Activity Classifier" questionnaire, adapted from the PEFS Guide of the Catalan Government.
Measured: At week 0, week 1, week 3, week 4 and week 6.
Whole Blood Transcriptomic Profile (RNA-seq)
Gene expression will be analyzed in whole blood samples preserved in PAXgene Blood RNA tubes.
Measured: At week 1, week 3, week 4 and week 6.
Concomitant medication
The use of any concomitant medication will be recorded through participant-reported entries in the case report form.
Measured: At week 0, week 1, week 3, week 4 and week 6.
Heart Rate
Heart rate will be measured using the Omron HEM-907 monitor.
Measured: At week 0, week 1, week 3, week 4 and week 6.
Systolic Blood Pressure
Systolic Blood Pressure will be measured using the Omron HEM-907 monitor.
Measured: At week 0, week 1, week 3, week 4 and week 6.
Diastolic Blood Pressure
Diastolic Blood Pressure will be measured using the Omron HEM-907 monitor.
Measured: At week 0, week 1, week 3, week 4 and week6.
Use of Dietary Supplements
Dietary supplements consumed during the study will be recorded in the case report form.
Measured: At week 0, week 1, week 3, week 4 and week 6.
Intervention Compliance (Supplement Intake Adherence)
Compliance with the intervention will be assessed indirectly by calculating the ratio between the number of supplement sachets theoretically assigned and the number actually consumed.
Measured: At week 3 and week 6.
Adverse events
Possible adverse events derived from taking study's products will be recorded in the case report form
Measured: At week 3 and week 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start1 Aug 2025
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Eurecat
- Sponsor type
- University, hospital or other
- Collaborators
- Circe, S.L.
- Responsible party
- Principal investigator, Antoni Caimari, Fundació Eurecat
- Investigators
- Antoni Caimari, PhD, Principal investigator, Fundació Eurecat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024966
- Sponsor's protocol ID
- PT-SILAOX
- Acronym
- PT-SILAOX
- Status last verified
- Aug 2025
- First submitted
- 9 Jun 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07024966
- Acronym / sponsor ID
- PT-SILAOX / PT-SILAOX
- Conditions
- Oxidative Stress, Physical Activity, Antioxidant Effect
- Keywords
- Oxidative Stress, High-intensity exercise, Pterostilbene, Antioxidant supplement, Nutraceutical, Crossover trial, Exercise recovery, Nutritional intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Fundació EurecatUniversity, hospital or other
- Collaborators
- Circe, S.L.
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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)..
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Control GroupParticipants treated with Microcrystalline Cellulose for 14 days |
| ccPT-SIL-NR Group | Experimental | Dietary Supplement: Pterostilbene-silybin-nicotinamide ribosideParticipants treated with pterostilbene, silybin, and nicotinamide riboside for 14 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pterostilbene-silybin-nicotinamide ribosideParticipants will take 2 sachets, each containing 340 mg of ccPT, silybin and nicotinamide riboside, and 1.91 g of excipients. | Dietary supplement | ccPT-SIL-NR Group |
| Control GroupParticipants will take 2 sachets, each containing 340 mg microcrystalline cellulose, and 1.91 g of excipients. | Dietary supplement | Placebo |
Primary outcome
Malondialdehyde (MDA) plasma levels
Time frame: At week 1, week 3, week 4 and week 6.
Plasma MDA levels will be measured using commercial ELISA kits
29 secondary outcomes
Age
Time frame: At week 0 (pre-selection visit)
Height (cm)
Time frame: At week 0 (pre-selection visit)
Body Weight (Kg)
Time frame: At week 0 (pre-selection visit)
Body Mass Index (BMI) (Kg/m^2)
Time frame: At week0 (pre-selection visit)
Urine 8-hydroxy-2'-deoxyguanosine (8-OHdG) levels
Time frame: At week 1, week 3, week 4 and week 6.
Urine F2-isoprostanes levels
Time frame: At week 1, week 3, week 4 and week 6.
Plasma antioxidant capacity
Time frame: At week 1, week 3, week 4 and week 6.
Erythrocyte Redox Status (GSH/GSSG Ratio)
Time frame: At week 1, week 3, week 4 and week 6.
Superoxide Dismutase (SOD) Activity
Time frame: At week 1, week 3, week 4 and week 6.
Catalase (CAT) Activity
Time frame: At week 1, week 3, week 4 and week 6.
Glutathione Peroxidase (GPx) Activity
Time frame: At week 1, week 3, week 4 and week 6.
Serum High-Sensitivity C-Reactive Protein (hs-CRP) Levels
Time frame: At week 1, week 3, week 4 and week 6.
Plasma Monocyte Chemoattractant Protein-1 (MCP-1) Levels
Time frame: At week 1, week 3, week 4 and week 6.
Plasma Interleukin-6 (IL-6) Levels
Time frame: At week 1, week 3, week 4 and week 6.
Plasma Lactate Dehydrogenase (LDH) Levels
Time frame: At week 1, week 3, week 4 and week 6.
Plasma Creatine Kinase (CK) Levels
Time frame: At week 1, week 3, week 4 and week 6.
Serum Cortisol Levels
Time frame: At week 1, week 3, week 4 and week 6.
Urinary Creatinine Levels
Time frame: At week 1, week 3, week 4 and week 6.
Maximal Oxygen Uptake (VO₂ max)
Time frame: At week 1.
Heart Rate, Treadmill Speed and Incline
Time frame: At week 1.
Physical Activity Level (Questionnaire-Based)
Time frame: At week 0, week 1, week 3, week 4 and week 6.
Whole Blood Transcriptomic Profile (RNA-seq)
Time frame: At week 1, week 3, week 4 and week 6.
Concomitant medication
Time frame: At week 0, week 1, week 3, week 4 and week 6.
Heart Rate
Time frame: At week 0, week 1, week 3, week 4 and week 6.
Systolic Blood Pressure
Time frame: At week 0, week 1, week 3, week 4 and week 6.
Diastolic Blood Pressure
Time frame: At week 0, week 1, week 3, week 4 and week6.
Use of Dietary Supplements
Time frame: At week 0, week 1, week 3, week 4 and week 6.
Intervention Compliance (Supplement Intake Adherence)
Time frame: At week 3 and week 6.
Adverse events
Time frame: At week 3 and week 6.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Technological Centre of Nutrition and Health. Eurecat\_Reus.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antoni Caimari, PhD principal investigator
Fundació Eurecat
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pterostilbene-silybin-nicotinamide riboside in people with Oxidative Stress and Physical Activity, run by Fundació Eurecat at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antoni Caimari, PhD (+34 977 300 431 ext. 4814, antoni.caimari@eurecat.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Malondialdehyde (MDA) plasma levels (time frame: At week 1, week 3, week 4 and week 6.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.