Healthy Participants
Conditions
Keywords
Beta-glucan, exercise, immune system, cancer
Brief summary
The goal of this clinical trial is to learn if beta-glucan (a dietary fiber) improves the function of the immune system in adults. It will also tell the investigators if combining beta-glucan with single bouts of exercise provides additional benefit. The main questions it aims to answer are: 1. Does beta-glucan change the ability of immune cells to recognize cancer cells? 2. Does exercise change the type of immune cells in the blood? Researchers will compare beta-glucan to a placebo (a look-alike substance with no effect) to see if beta-glucan could improve immune function against cancer. Participants will: 1. Take beta-glucan or a placebo daily for 4 weeks. 2. Visit the laboratory for three exercise tests. 3. Provide blood samples so researchers can study immune system cells.
Detailed description
This investigation is a randomized, placebo-controlled trial seeking to determine the extent to which acute exercise and dietary β-glucan supplementation can augment immune responses against cancer. The investigators will mechanistically determine the receptor-ligand interactions between effector lymphocytes and target cancer cells, as well as assess multiple immunotherapies alongside the intervention (e.g., ipilimumab, pembrolizumab, monalizumab). Incorporating lifestyle medicine is well known to improve patient quality of life, and early evidence suggests it may favorably impact overall survival. It is crucial that the investigators harness the immunological potential of lifestyle interventions to broadly improve immunotherapy effectiveness.
Interventions
DIETARY_SUPPLEMENTBeta-glucan
375mg of beta-glucan in the form of a ground mushroom powder. The supplement is provided in capsule form.
DIETARY_SUPPLEMENTPlacebo
375mg of microcrystalline cellulose in capsule form.
Sponsors
Florida State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Physically fit enough to engage in maximal exercise.
Exclusion criteria
* BMI \> 40 kg/m2 * Stage 2 hypertension (140/90 mmHg) * Type I or II diabetes * Autoimmune diseases * Overt cardiovascular, respiratory, or neurological disease (e.g., previous heart attack, pacemaker, heart failure, asthma) * Hormone replacement therapy (e.g., androgens, estrogens) * Daily medication usage that may affect immune function (e.g., beta blockers, NSAIDs, corticosteroids, allergy medications) * Current antibiotic use * Heavy alcohol usage (\>2 drinks per day) * Tobacco use within the last 6 months * Adults unable to consent * Individuals who are not yet adults (infants, children, teenagers) * Self-reported pregnancy * Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cellular Cytotoxicity Assessed With Flow Cytometry | At baseline, the end of treatment at four weeks, and at eight weeks after a washout phase. | The ability of participant peripheral blood mononuclear cells (PBMCs) to kill target cancers cells in vitro. PBMCs will be co-cultured with cancer cells for four hours, and the number of cancer cells killed over time will be quantified with flow cytometry (e.g., CD71+ labeled cancer cells with compromised cell membranes). |
Countries
United States
Contacts
Primary ContactKyle A Smith, PhD, RD
Outcome results
None listed