Researching Economical Adjuvants to Cancer Therapy (REACT)

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Dietary supplement: Beta-glucan; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Kyle A Smith, PhD, RD; Phone Number: 850-644-1016; Email: k.smith@fsu.edu

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32306
      • Recruiting
      • Institute of Sports Sciences and Medicine
      • Contact: Kyle A Smith, PhD, RD; Phone Number: 8506451016; Email: k.smith@fsu.edu
      • Principal Investigator: Kyle A Smith, PhD, RD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Beta-glucan; 375mg of beta-glucan is provided daily for 4 weeks.	Dietary supplement: Beta-glucan; 375mg of beta-glucan in the form of a ground mushroom powder. The supplement is provided in capsule form.
Placebo Comparator: Placebo; 375mg of cellulose daily for 4 weeks.	Dietary supplement: Placebo; 375mg of microcrystalline cellulose in capsule form.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cellular Cytotoxicity Assessed With Flow Cytometry	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).	At baseline, the end of treatment at four weeks, and at eight weeks after a washout phase.

Collaborators and Investigators

• Sponsor: Florida State University

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2025
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2029

Study Registration Dates

• First Submitted: November 21, 2025
• First Submitted That Met QC Criteria: December 12, 2025
• First Posted (Actual): December 26, 2025

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: exercise; cancer; immune system; Beta-glucan
• Additional Relevant MeSH Terms: Behavior; Neoplasms; Motor Activity; Carbohydrates; Polysaccharides; Glucans; beta-Glucans
• Other Study ID Numbers: 00005291

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No