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A Randomized, Double-Blinded, Placebo-Controlled, Parallel Study, to....

A Randomized, Double-Blinded, Placebo-Controlled, Parallel Study, to....

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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

LU IRB#: IRB-24-16
PI: Chad Kerksick, PhD

Description of Study

The aim of the research study is to evaluate the antioxidative and ergogenic potential of a novel postbiotic blend in healthy, recreationally active men and women.

Location
Exercise and Performance Nutrition Laboratory (Fieldhouse 126)
209 S Kingshighway St
Saint Charles, MO 63301

Number of Visits
4

Compensation
$250

Points of Contact
Wyatt McLaughlin
epnl@lindenwood.edu

Research Sample Needed

  • 50-60 healthy, active men and women

Inclusion 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 >5 to <29.9 kg/m(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. 

Exclusion Criteria

  • Body mass index <18.5 to >29.9 kg/m2
  • 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)
  • 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.
  • Participant reports any allergy to the ingredients provided in both the placebo or experimental groups

Are You Eligible?

Information provided here reflects current IRB approval for this research. However, this information may be subject to change and updated accordingly.

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