HealthyNCT06851039
Effects of the Short-Chain Fatty Acids-Targeted Dietary Interventions on the Selected Autonomic Functions in Humans
A study testing Potato starch supplementation, Sodium butyrate supplementation and Accessible starch supplementation in people with Healthy, run by Wroclaw Medical University at 1 site in Poland.
Trial summary
Recent data feature short-chain fatty acids (SCFAs), products of gut microbial fermentation, as modulators of the blood pressure of the host. Such modulation may evoke (or arise from) changes in the autonomic reflexive mechanisms, but the link remains unexplored. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Potato starch supplementation, Sodium butyrate supplementation and Accessible starch supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 sitePoland
- Study dates
- 6 Mar 2025to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18-40 years
Who cannot join
- chronic disease of the nervous, cardiovascular or respiratory system
- disease of the digestive system, including history of the intestinal surgery, inflammatory bowel disease, celiac disease, lactose intolerance and other malabsorption disorders
- blood pressure-lowering treatment within the past year
- tobacco smoking within the past year
- antibiotic/probiotic treatment and laxative/prokinetic usage in three months preceding the anticipated enrollment
Trial locations and contacts
1 site in 1 country.
Poland1 site
Wroclaw Medical University
Wroclaw, Lower Silesian Voivodeship, 50-367
About this study
Official title: Effects of the Resistant Starch and Sodium Butyrate Supplementation on the Respiratory and Cardiovascular Autonomic Control in Humans
Recent data feature short-chain fatty acids (SCFAs), products of gut microbial fermentation, as modulators of the blood pressure of the host. Such modulation may evoke (or arise from) changes in the autonomic reflexive mechanisms, but the link remains unexplored. Therefore, the study aims to explore potential relationship between the dietary intervention-induced changes in the SCFA plasma/fecal content and alterations in the sensitivity of the cardio-respiratory autonomic reflexes.
In this cross-over, placebo-controlled study, a group of healthy volunteers will undergo three distinct stages of a four-week dietary intervention, separated by at least two weeks of washout periods. During each stage, participants will receive one of the following interventions:
- raw potato starch (a source of resistant type 2 starch, which is a substrate for the endogenous production of SCFAs)
- sodium butyrate (a direct, exogenous source of this SCFA)
- an amylase-accessible waxy maze starch (a placebo). Plasma and fecal SCFA concentrations will be measured, along with the comprehensive evaluation of the cardio-respiratory parameters and the sensitivity of the autonomic reflexive mechanisms.
- Conditions
- Healthy
- Being tested
- Potato starch supplementation, Sodium butyrate supplementation, Accessible starch supplementation
- Keywords
- resistant starch, short-chain fatty acids, gut microbiota, peripheral chemoreflex, arterial baroreflex, autonomic nervous system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potato starch supplementationDietary supplement
Participants will receive potato starch supplement, undergoing gut microbial fermentation and acting as an endogenous source of the short-chain fatty acids, including butyrate. Effects of these compounds on the selected autonomic functions (i.e. cardio-respiratory control) will be further investigated.
Sodium butyrate supplementationDietary supplement
Participants will receive sodium butyrate supplement, acting as an exogenous source of the short-chain fatty acid butyrate. Effects of such compound on the selected autonomic functions (i.e. cardio-respiratory control) will be further investigated.
Accessible starch supplementationDietary supplement
Participants will receive the accessible (digestible) waxy maze starch as placebo.
| Study group | Role | What they receive |
|---|---|---|
| potato starch | Experimental | Not described Receives: Dietary Supplement: Potato starch supplementation |
| sodium butyrate | Experimental | Not described Receives: Dietary Supplement: Sodium butyrate supplementation |
| accessible maze starch | Placebo comparator | Not described Receives: Dietary Supplement: Accessible starch supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial baroreflex sensitivity
Arterial baroreflex sensitivity, measured with a neck chamber technique.
Measured: From the beginning to the end of a supplementation period at 4 weeks.
Peripheral chemoreflex sensitivity
Peripheral chemoreflex sensitivity, measured with the transient hypoxia test.
Measured: From the beginning to the end of a supplementation period at 4 weeks.
Secondary outcomes (1)
Plasma short-chain fatty acids
Plasma level of short-chain fatty acids, evaluated with high-performance liquid chromatography.
Measured: From the beginning to the end of a supplementation period at 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start6 Mar 2025
- Primary completion15 Sep 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafał Seredyński, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851039
- Sponsor's protocol ID
- STM.A090.20.110
- Status last verified
- Sep 2025
- First submitted
- 13 Feb 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a small trial which includes solely healthy volunteers. Therefore, data will not be shared at this instance.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Resistant Starch and Sodium Butyrate Supplementation on the Respiratory and Cardiovascular Autonomic Control in Humans
- ClinicalTrials.gov ID
- NCT06851039
- Acronym / sponsor ID
- STM.A090.20.110
- Conditions
- Healthy
- Keywords
- resistant starch, short-chain fatty acids, gut microbiota, peripheral chemoreflex, arterial baroreflex, autonomic nervous system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 6 Mar 2025 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 28 Feb 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.
Recent data feature short-chain fatty acids (SCFAs), products of gut microbial fermentation, as modulators of the blood pressure of the host. Such modulation may evoke (or arise from) changes in the autonomic reflexive mechanisms, but the link remains unexplored. Therefore, the study aims to explore potential relationship between the dietary intervention-induced changes in the SCFA plasma/fecal content and alterations in the sensitivity of the cardio-respiratory autonomic reflexes.
In this cross-over, placebo-controlled study, a group of healthy volunteers will undergo three distinct stages of a four-week dietary intervention, separated by at least two weeks of washout periods. During each stage, participants will receive one of the following interventions:
- raw potato starch (a source of resistant type 2 starch, which is a substrate for the endogenous production of SCFAs)
- sodium butyrate (a direct, exogenous source of this SCFA)
- an amylase-accessible waxy maze starch (a placebo). Plasma and fecal SCFA concentrations will be measured, along with the comprehensive evaluation of the cardio-respiratory parameters and the sensitivity of the autonomic reflexive mechanisms.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| potato starch | Experimental | Dietary Supplement: Potato starch supplementation |
| sodium butyrate | Experimental | Dietary Supplement: Sodium butyrate supplementation |
| accessible maze starch | Placebo comparator | Dietary Supplement: Accessible starch supplementation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- age 18-40 years
Key exclusion criteria (5 listed)
- chronic disease of the nervous, cardiovascular or respiratory system
- disease of the digestive system, including history of the intestinal surgery, inflammatory bowel disease, celiac disease, lactose intolerance and other malabsorption disorders
- blood pressure-lowering treatment within the past year
- tobacco smoking within the past year
- antibiotic/probiotic treatment and laxative/prokinetic usage in three months preceding the anticipated enrollment
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 |
|---|---|---|
| Potato starch supplementationParticipants will receive potato starch supplement, undergoing gut microbial fermentation and acting as an endogenous source of the short-chain fatty acids, including butyrate. Effects of these compounds on the selected autonomic functions (i.e. cardio-respiratory control) will be further investigated. | Dietary supplement | potato starch |
| Sodium butyrate supplementationParticipants will receive sodium butyrate supplement, acting as an exogenous source of the short-chain fatty acid butyrate. Effects of such compound on the selected autonomic functions (i.e. cardio-respiratory control) will be further investigated. | Dietary supplement | sodium butyrate |
| Accessible starch supplementationParticipants will receive the accessible (digestible) waxy maze starch as placebo. | Dietary supplement | accessible maze starch |
Primary outcome
Arterial baroreflex sensitivity
Time frame: From the beginning to the end of a supplementation period at 4 weeks.
Arterial baroreflex sensitivity, measured with a neck chamber technique.
Peripheral chemoreflex sensitivity
Time frame: From the beginning to the end of a supplementation period at 4 weeks.
Peripheral chemoreflex sensitivity, measured with the transient hypoxia test.
1 secondary outcome
Plasma short-chain fatty acids
Time frame: From the beginning to the end of a supplementation period at 4 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: No. This is a small trial which includes solely healthy volunteers. Therefore, data will not be shared at this instance.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Potato starch supplementation, Sodium butyrate supplementation and Accessible starch supplementation in people with Healthy, run by Wroclaw Medical University at 1 site in Poland.
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 5 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: finished, as of the sponsor's last update on 23 Sep 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 Poland. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial baroreflex sensitivity (time frame: From the beginning to the end of a supplementation period at 4 weeks.). The study lists 2 primary outcomes in all. 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 23 Sep 2025.