Healthy ParticipantsEarly Phase 1REACTNCT07305259
Researching Economical Adjuvants to Cancer Therapy
A Early Phase 1 study testing Beta-glucan in people with Healthy Participants, run by Florida State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Beta-glucan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2025to 30 Sep 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Physically fit enough to engage in maximal exercise.
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Institute of Sports Sciences and Medicine
Tallahassee, Florida, 32306
Kyle A Smith, PhD, RD, 8506451016, k.smith@fsu.edu
Kyle A Smith, PhD, RD
About this study
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:
- Does beta-glucan change the ability of immune cells to recognize cancer cells?
- 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.
Read more
Participants will:
- Take beta-glucan or a placebo daily for 4 weeks.
- Visit the laboratory for three exercise tests.
- Provide blood samples so researchers can study immune system cells.
Read the 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.
- Conditions
- Healthy Participants
- Being tested
- Beta-glucan, Placebo
- Keywords
- Beta-glucan, exercise, immune system, cancer
- Medical subject headings
- Motor Activity, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta-glucanDietary supplement
375mg of beta-glucan in the form of a ground mushroom powder. The supplement is provided in capsule form.
PlaceboDietary supplement
375mg of microcrystalline cellulose in capsule form.
| Study group | Role | What they receive |
|---|---|---|
| Beta-glucan | Experimental | 375mg of beta-glucan is provided daily for 4 weeks. Receives: Dietary Supplement: Beta-glucan |
| Placebo | Placebo comparator | 375mg of cellulose daily for 4 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At baseline, the end of treatment at four weeks, and at eight weeks after a washout phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start12 Nov 2025
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyle Smith, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07305259
- Sponsor's protocol ID
- 00005291
- Acronym
- REACT
- Status last verified
- Dec 2025
- First submitted
- 21 Nov 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Researching Economical Adjuvants to Cancer Therapy
- ClinicalTrials.gov ID
- NCT07305259
- Acronym / sponsor ID
- REACT / 00005291
- Conditions
- Healthy Participants
- Keywords
- Beta-glucan, exercise, immune system, cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 12 Nov 2025 (actual)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does beta-glucan change the ability of immune cells to recognize cancer cells?
- 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:
- Take beta-glucan or a placebo daily for 4 weeks.
- Visit the laboratory for three exercise tests.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beta-glucan | Experimental | Dietary Supplement: Beta-glucan375mg of beta-glucan is provided daily for 4 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo375mg of cellulose daily for 4 weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Physically fit enough to engage in maximal exercise.
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beta-glucan375mg of beta-glucan in the form of a ground mushroom powder. The supplement is provided in capsule form. | Dietary supplement | Beta-glucan |
| Placebo375mg of microcrystalline cellulose in capsule form. | Dietary supplement | Placebo |
Primary outcome
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.
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Beta-glucan in people with Healthy Participants, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kyle A Smith, PhD, RD (850-644-1016, k.smith@fsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.