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

What Was Tested

The trial (not phased) is built around NAD+.

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.

It had two arms (groups): Placebo (placebo comparator) and ccPT-SIL-NR Group (experimental).

Participants treated with Microcrystalline Cellulose for 14 days.

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

The registry classes the interventions as dietary supplement.

More on the Plan

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.

The trial is a randomized, triple-blind, placebo-controlled, and crossover study.

Fourteen healthy, physically active men aged 18-50 will be recruited.

Who Took Part

The registry lists 14 planned participants were the target.

It was open to men only aged from 18 years up to 50 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Male participants between 18 and 50 years of age who are amateur runners. 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.

The full record lists 6 inclusion and 14 exclusion criteria; among the exclusions: body mass index (bmi) ≤ 18 kg/m² or ≥ 30 kg/m²; 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.

How the Study Was Run

It was run as a randomized, crossover and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got NAD+ and who got the comparison, which limits bias.

Each person switched between NAD+ and the comparison at some point, usually with a gap in between.

Neither the participants nor the staff measuring them knew who was on NAD+, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2025-08-01 with completion listed for 2025-11.

It ran at 1 site in Spain.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Malondialdehyde (MDA) plasma levels (time frame: At week 1, week 3, week 4 and week 6).

It also tracked 29 secondary outcomes, for example Age, Height (cm), Body Weight (Kg), Body Mass Index (BMI) (Kg/m^2), Urine 8-hydroxy-2'-deoxyguanosine (8-OHdG) levels and Urine F2-isoprostanes levels.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of NAD+ in 14 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the NAD+ compound page, all human trials.