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

NCT06795425 | Not Yet Recruiting

• 2 other identifiers: CTB2022TN206IRB-24-16
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oxidative Stress; Healthy; Exercise-induced Muscle Damage; Exercise-induced Muscle Soreness; Immune Function; Gut Health; Microbiome Analysis; Exercise Performance; Exercise Metabolism

Keywords

oxidative stress; antioxidants; postbiotics; ergogenic aid; exercise performance; muscle damage; recovery; gut microbiome; immune function; sleep quality; anxiety; recreationally active; inflammation; endurance training; fecal microbiota; nutritional supplement; aerobic exercise; biomarkers; clinical trial

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Serum Malondialdehyde Concentrations 30 Minutes Before and 30 Minutes After Exercise Completion After 0 and 8 Weeks of Supplementation

  Serum malondialdehyde (MDA) concentration will be measured to assess the effect of the postbiotic blend on lipid peroxidation and oxidative stress. Higher MDA levels indicate increased oxidative stress.

  30 minutes before and 30 minutes after exercise completion at baseline (0 weeks) and after 8 weeks of supplementation.

Secondary Outcomes (29)

• 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

  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

  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

  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

  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

  30 minutes before and 30 minutes after exercise completion at baseline and after 8 weeks of supplementation.

Other Outcomes (2)

• Change from Baseline in Gut Microbiome Composition Using Shotgun Metagenomic Sequencing (Fecal) During the 24 Hours Before and 24 Hours After Exercise Completion at 0 and 8 Weeks of Supplementation

  24 hours before and 24 hours after exercise completion at baseline (0 weeks) and after 8 weeks of supplementation.

• Change from Baseline in Fecal Metabolomic Profile During the 24 Hours Before and 24 Hours After Exercise Completion at 0 and 8 Weeks of Supplementation

  24 hours before and 24 hours after exercise completion at baseline (0 weeks) and after 8 weeks of supplementation.

Study Arms (2)

Postbiotic Active Lifestyle Blend

EXPERIMENTAL

Participants in this arm will receive the active Postbiotic Active Lifestyle Blend supplement, which contains a heat-treated blend of bacterial strains

Dietary Supplement: Postbiotic Active Lifestyle Blend

Placebo

PLACEBO COMPARATOR

Participants in this arm will receive a placebo capsule that matches the appearance and dosage of the active blend.

Other: Placebo

Interventions

Postbiotic Active Lifestyle Blend DIETARY_SUPPLEMENT

The active intervention, Postbiotic Active Lifestyle Blend, containing a heat-treated blend of bacterial strains; 2 capsules per day.

Postbiotic Active Lifestyle Blend

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lindenwood University: lead
• Archer Daniels Midland Co.: collaborator

Study Sites (1)

Exercise and Performance Nutrition Laboratory

Saint Charles, Missouri, 63301, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Anxiety Disorders; Inflammation

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chad M Kerksick, PhD

  Lindenwood University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony M Hagele, MS

CONTACT

636-949-4785; ahagele@lindenwood.edu

Joesi M Krieger, MS

CONTACT

636-339-6942; jmorey@lindenwood.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: To maintain blinding, each participant is assigned a unique randomization number, rather than a direct treatment label (e.g., "A" or "B"). Treatments are provided with coded labels, ensuring that participants, investigators, outcome assessors, and any other study staff involved in data collection remain unaware of the group assignments throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study uses a randomized, double-blind, parallel design with two groups. Participants are assigned to either the active postbiotic blend group or a placebo group to evaluate the blend's effects on oxidative stress, muscle recovery, immune function, and exercise performance.

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 28, 2025
• Study Start: February 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)