Researching Economical Adjuvants to Cancer Therapy

NCT07305259 | Recruiting Early Phase 1

• 1 other identifier: 00005291
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 1.Does beta-glucan change the ability of immune cells to recognize cancer cells?
2. 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.
3. 3.Take beta-glucan or a placebo daily for 4 weeks.
4. 4.Visit the laboratory for three exercise tests.
5. 5.Provide blood samples so researchers can study immune system cells.

Conditions

Healthy Participants

Keywords

Beta-glucan; exercise; immune system; cancer

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Beta-glucan

EXPERIMENTAL

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

Dietary Supplement: Beta-glucan

Placebo

PLACEBO COMPARATOR

375mg of cellulose daily for 4 weeks.

Dietary Supplement: Placebo

Interventions

Beta-glucan DIETARY_SUPPLEMENT

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

Beta-glucan

Placebo DIETARY_SUPPLEMENT

375mg of microcrystalline cellulose in capsule form.

Placebo

Eligibility Criteria

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

You may qualify if:

• Physically fit enough to engage in maximal exercise.

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Institute of Sports Sciences and Medicine

Tallahassee, Florida, 32306, United States

RECRUITING

MeSH Terms

Conditions

Motor Activity; Neoplasms

Interventions

beta-Glucans

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Glucans; Polysaccharides; Carbohydrates

Central Study Contacts

Kyle A Smith, PhD, RD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 26, 2025
• Study Start: November 12, 2025
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)