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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2026-01-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

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Postbiotic Active Lifestyle Blend

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

Group Type EXPERIMENTAL

Postbiotic Active Lifestyle Blend

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Interventions

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Postbiotic Active Lifestyle Blend

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

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes