Recruiting
Early Phase 1

Beta-Glucan

Sponsor:

Florida State University

Code:

NCT07305259

Conditions

Healthy Participants

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Beta-glucan

Placebo

Study Details

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.

Conditions

Healthy Participants

Study ID

NCT07305259

Start date

Nov 12, 2025

Status verified date

Dec, 2025

Completion date

Sep 30, 2029

Anticipated

Primary completion date

Sep 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Beta-glucan

375mg of beta-glucan is provided daily for 4 weeks.

placebo comparator: Placebo

375mg of cellulose daily for 4 weeks.

Interventions

Beta-glucan

375mg of beta-glucan in the form of a ground mushroom powder. The supplement is provided in capsule form.

Placebo

375mg of microcrystalline cellulose in capsule form.

Primary outcome measure

  • Cellular Cytotoxicity Assessed With Flow Cytometry [ Time Frame: At baseline, the end of treatment at four weeks, and at eight weeks after a washout phase. ]

Central Contacts and Locations

Central contacts

Kyle A Smith, PhD, RD

850-644-1016k.smith@fsu.edu

Locations

Institute of Sports Sciences and Medicine

Recruiting

Tallahassee, Florida, United States, 32306

Contacts

Kyle A Smith, PhD, RD

8506451016k.smith@fsu.edu

Principal Investigator:

Kyle A Smith, PhD, RD

More Information

Sponsor

Florida State University

Last update posted

Dec 26, 2025

Last verified

Dec, 2025

Keywords

  • Beta-glucan
  • exercise
  • immune system
  • cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-07. This information was provided to ClinicalTrials.gov by Florida State University on 2025-12-26.