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

Launched by LINDENWOOD UNIVERSITY · Jan 21, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to study the effects of a special blend of postbiotics on exercise performance and oxidative stress in healthy adults. Oxidative stress is a condition that can occur during exercise, leading to muscle soreness and damage. The researchers want to see if this postbiotic blend can help reduce these effects and improve how well people perform during physical activity.

To participate in the study, individuals must be between 18 and 45 years old, physically active (exercising 2 to 5 times a week), and in good health without serious medical conditions. Participants will be randomly assigned to receive either the postbiotic blend or a placebo (a non-active treatment) without knowing which one they are receiving. This study is not yet recruiting, but once it begins, participants can expect to follow specific guidelines and complete various procedures related to their health and exercise performance. It’s important to note that individuals with certain health issues, recent antibiotic or probiotic use, or other specific conditions will not be eligible to join the study.

Gender

ALL

Eligibility criteria

• • INCLUSION CRITERIA
• To be eligible for inclusion, the participant must fulfill all of the following criteria:
• • 1. Male or female participants between 18 - 45 years of age
• • 2. Signed informed consent.
• • 3. 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.
• • 4. 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)
• • 5. Body mass index values will range from \>18.5 to \< 29.9 kg/m2 (Inclusive)41 (Weir and Jan 2024).
• • 6. 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.
• • EXCLUSION CRITERIA
• Participants will be excluded from the study if they meet any of the following criteria:
• • 1. Body mass index \<18.5 to \<29.9 kg/m2 (Inclusive)
• • 2. Use of antibiotics or probiotics in the previous 3 months
• • 3. 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.
• • 4. Diagnosed with having Type I or Type II diabetes (determined as fasting blood glucose \> 126 mg/dL)
• • 5. Diagnosed with major affective disorder or other significant psychiatric disorder or disturbance that required hospitalization or home intervention in the prior year.
• • 6. History of cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit).
• • 7. 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)
• • 8. 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.
• • 9. Consumption (any dose or amount) of any nicotine-containing product (cigarette, cigar, vaping, etc.)
• • 10. Participants who are lactating, pregnant or planning to become pregnant.
• • 11. History of alcohol or substance abuse in the 12 months prior to screening
• • 12. Receipt or use of an investigational product in another research study within 60 days of beginning the study protocol.
• • 13. 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.
• • 14. Extensive travel (\>1 month) that will disrupt original outline of the study protocol.
• • 15. 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.