Effects of the Short-Chain Fatty Acids-Targeted Dietary Interventions on the Selected Autonomic Functions in Humans

September 18, 2025 updated by: Rafał Seredyński, Wroclaw Medical University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 50-367
        • Wroclaw Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • age 18-40 years

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: potato starch
Dietary supplement: Potato starch supplementation
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.
Experimental: sodium butyrate
Dietary supplement: Sodium butyrate supplementation
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.
Placebo Comparator: accessible maze starch
Dietary supplement: Accessible starch supplementation
Participants will receive the accessible (digestible) waxy maze starch as placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the beginning to the end of a supplementation period at 4 weeks.
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.
From the beginning to the end of a supplementation period at 4 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma short-chain fatty acids
Time Frame: From the beginning to the end of a supplementation period at 4 weeks.
Plasma level of short-chain fatty acids, evaluated with high-performance liquid chromatography.
From the beginning to the end of a supplementation period at 4 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wroclaw Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2025

Primary Completion (Actual)

September 15, 2025

Study Completion (Actual)

September 15, 2025

Study Registration Dates

First Submitted

February 13, 2025

First Submitted That Met QC Criteria

February 24, 2025

First Posted (Actual)

February 28, 2025

Study Record Updates

Last Update Posted (Estimated)

September 23, 2025

Last Update Submitted That Met QC Criteria

September 18, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STM.A090.20.110

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is a small trial which includes solely healthy volunteers. Therefore, data will not be shared at this instance.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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