A Randomized, Double-Blind Study to Assess the Effect of a Postbiotic on Oxidative Stress and Exercise Performance

Официальное название

A Randomized, Double-Blinded, Placebo-Controlled, Parallel Study, to Assess the Effect of a Novel Postbiotic Blend on Exercise Induced Oxidative Stress Markers and Exercise Performance

Обзор

This is a prospective, randomized, placebo controlled, double-blind study to assess the effects of a postbiotic blend on exercise induced oxidative stress markers and exercise performance in healthy adult.

Подробное описание

This randomized, double-blind, placebo-controlled study will evaluate the effect of a novel postbiotic blend on oxidative stress markers and exercise performance in healthy, physically active adults. The study aims to determine whether the postbiotic supplement can reduce oxidative stress and enhance exercise outcomes over an 8-week period.

Participants will be randomly assigned to receive either the postbiotic blend or a placebo in a double-blind fashion. The study includes an 8-week intervention period, with baseline and follow-up assessments conducted to evaluate changes in key biomarkers and performance metrics.

The primary outcome measure will focus on changes in malondialdehyde concentrations, a key marker of oxidative stress. Secondary outcomes will include assessments of other oxidative stress markers, immune function, and exercise performance. Detailed descriptions of these outcome measures are provided in the "Outcome Measures" section.

Participants will undergo a series of assessments at baseline, mid-study, and post-intervention. These assessments include blood draws, VO2 peak testing, and exercise performance tests. Participants will also be required to maintain a daily diary documenting their health status, medication/supplement use, and any adverse events.

The total study duration is 8-10 weeks, including a pre-study screening phase, 8 weeks of intervention, and a follow-up assessment.

Вмешательства

• Пищевая добавка Postbiotic Active Lifestyle Blend
  The active intervention, Postbiotic Active Lifestyle Blend, containing a heat-treated blend of bacterial strains; 2 capsules per day.
• Другое Placebo
  The placebo intervention contains no active ingredients and consists of maltodextrin as an inactive ingredient. The capsule matches the appearance and dosage form of the active intervention.

Первичные конечные точки

• Change from Baseline in Serum Malondialdehyde Concentrations 30 Minutes Before and 30 Minutes After Exercise Completion After 0 and 8 Weeks of Supplementation [Срок оценки: 30 minutes before and 30 minutes after exercise completion at baseline (0 weeks) and after 8 weeks of supplementation.]

Вторичные конечные точки (12)

• Change from Baseline in Urine 8-OHdG During the 24 Hours Before and 24 Hours After Exercise Completion at 0 and 8 Weeks of Supplementation [Срок оценки: 24 hours before and 24 hours after exercise completion at baseline and after 8 weeks of supplementation.]
• Change from Baseline in Serum Oxidized LDL Concentrations 30 Minutes Before and 30 Minutes After Exercise Completion at 0 and 8 Weeks of Supplementation [Срок оценки: 30 minutes before and 30 minutes after exercise completion at baseline and after 8 weeks of supplementation.]
• Change from Baseline in Serum Glutathione Peroxidase Activity 30 Minutes Before and 30 Minutes After Exercise Completion at 0 and 8 Weeks of Supplementation [Срок оценки: 30 minutes before and 30 minutes after exercise completion at baseline and after 8 weeks of supplementation.]
• Change from Baseline in Urinary 8-Isoprostane Levels During the 24 Hours Before and 24 Hours After Exercise Completion at 0 and 8 Weeks of Supplementation [Срок оценки: 24 hours before and 24 hours after exercise completion at baseline and after 8 weeks of supplementation.]
• Change from Baseline in Serum Total Antioxidant Status (TAS) 30 Minutes Before and 30 Minutes After Exercise Completion at 0 and 8 Weeks of Supplementation [Срок оценки: 30 minutes before and 30 minutes after exercise completion at baseline and after 8 weeks of supplementation.]
• Change from Baseline in Serum Superoxide Dismutase Activity 30 Minutes Before and 30 Minutes After Exercise Completion at 0 and 8 Weeks of Supplementation [Срок оценки: 30 minutes before and 30 minutes after exercise completion at baseline and after 8 weeks of supplementation.]
• Change from Baseline in Serum Protein Carbonyl Levels 30 Minutes Before and 30 Minutes After Exercise Completion at 0 and 8 Weeks of Supplementation [Срок оценки: 30 minutes before and 30 minutes after exercise completion at baseline and after 8 weeks of supplementation.]
• Change from Baseline in Serum Uric Acid Levels 30 Minutes Before Exercise at 0 and 8 Weeks of Supplementation [Срок оценки: 30 minutes before exercise at baseline and after 8 weeks of supplementation.]
• Change from Baseline in Serum IgA Levels 30 Minutes Before Exercise at 0 and 8 Weeks of Supplementation [Срок оценки: 30 minutes before exercise at baseline and after 8 weeks of supplementation.]
• Change from Baseline in Serum IgM Levels 30 Minutes Before Exercise at 0 and 8 Weeks of Supplementation [Срок оценки: 30 minutes before exercise at baseline and after 8 weeks of supplementation.]
• Change from Baseline in Serum IgG Levels 30 Minutes Before Exercise at 0 and 8 Weeks of Supplementation [Срок оценки: 30 minutes before exercise at baseline and after 8 weeks of supplementation.]
• Change from Baseline in Serum Creatine Kinase Levels 30 Minutes Before and 30 Minutes After Exercise Completion at 0 and 8 Weeks of Supplementation [Срок оценки: 30 minutes before and 30 minutes after exercise completion at baseline and after 8 weeks of supplementation.]

Критерии участия

Критерии включения

To be eligible for inclusion, the participant must fulfill all of the following criteria:

• Male or female participants between 18 - 45 years of age
• Signed informed consent.
• Health, which is defined as currently not being treated for an active cardiac, pulmonary, metabolic, immunological, neurological, respiratory, orthopedic, musculoskeletal, psychiatric, or reproductive disease or disorder. With research team and principal investigator discretion, some ongoing treatments will be permitted if a determination is made that the treatment will not increase risk of study participation and the treatment or illness itself will not confound with desired study outcomes.
• Physically active, which is defined as performing aerobic or resistance-based physical exercise between 2 and 5 times per week at a rating of perceived intensity (RPE) of 4 or greater (out of 10)
• Body mass index values will range from >18.5 to < 29.9 kg/m2 (Inclusive)41 (Weir and Jan 2024).
• Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, and carry out all study-related procedures.

Критерии исключения

Participants will be excluded from the study if they meet any of the following criteria:

• Body mass index <18.5 to <29.9 kg/m2 (Inclusive)
• Use of antibiotics or probiotics in the previous 3 months
• Positive medical history and/or is currently being treated for some form of heart or cardiovascular, neurological impairment, disease or condition, immune disorder or disease, thyroid disease, kidney disease, renal failure, regular dialysis, liver disease or other diagnosed hepatic impairment.
• Diagnosed with having Type I or Type II diabetes (determined as fasting blood glucose > 126 mg/dL)
• Diagnosed with major affective disorder or other significant psychiatric disorder or disturbance that required hospitalization or home intervention in the prior year.
• History of cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit).
• Participant has an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, bile acid malabsorption, H.pylori infection, small intestine bacterial overgrowth (SIBO), celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea)
• Recently prescribed or change in dosage (within the past 6 months) of statin drug (i.e., Lipitor, Livalo, Crestor, Zocor, etc.), hypertension medications (i.e., Beta-blockers, ACE Inhibitors, Alpha blockers, Vasodilators, etc.), or psychiatric medications.
• Consumption (any dose or amount) of any nicotine-containing product (cigarette, cigar, vaping, etc.)
• Participants who are lactating, pregnant or planning to become pregnant.
• History of alcohol or substance abuse in the 12 months prior to screening
• Receipt or use of an investigational product in another research study within 60 days of beginning the study protocol.
• Any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data.
• Extensive travel (>1 month) that will disrupt original outline of the study protocol.
• Participant is consuming a biotic product (pre-, pro-, syn-, or post-) or alters their diet resulting in a change in the amount of prebiotic, probiotic, or fermented foods that are consumed while in the study protocol.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Exercise and Performance Nutrition Laboratory — Saint Charles

Идентификаторы

NCT: NCT06795425 · CTB2022TN206 · IRB-24-16

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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