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CompletedNCT06851039Updated Sep 23, 2025

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

An interventional study of Potato starch supplementation and Sodium butyrate supplementation in Healthy, sponsored by Wroclaw Medical University. Completed at 1 site in Poland. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-23.

Sponsored by Wroclaw Medical University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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. 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.
02

Conditions studied

  • Healthy

Keywords

  • resistant starch
  • short-chain fatty acids
  • gut microbiota
  • peripheral chemoreflex
  • arterial baroreflex
  • autonomic nervous system
03

In context

Lead sponsor

Wroclaw Medical University is the lead sponsor of 93 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • age 18-40 years

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    potato starch

    Dietary Supplement: Potato starch supplementation

  • Experimental
    sodium butyrate

    Dietary Supplement: Sodium butyrate supplementation

  • Placebo comparator
    accessible maze starch

    Dietary Supplement: Accessible starch supplementation

Interventions

  • Dietary supplementPotato 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.

  • Dietary supplementSodium 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.

  • Dietary supplementAccessible starch supplementation

    Participants will receive the accessible (digestible) waxy maze starch as placebo.

06

What researchers measure

Primary outcomes

  1. Arterial baroreflex sensitivity

    Arterial baroreflex sensitivity, measured with a neck chamber technique.

    Time frame: From the beginning to the end of a supplementation period at 4 weeks.

  2. Peripheral chemoreflex sensitivity

    Peripheral chemoreflex sensitivity, measured with the transient hypoxia test.

    Time frame: 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.

    Time frame: From the beginning to the end of a supplementation period at 4 weeks.

07

Study locations

1 site
  • Wroclaw Medical University
    Wroclaw, Lower Silesian Voivodeship 50-367, Poland
08

References and documents

Individual participant data

Plan to share: No — This is a small trial which includes solely healthy volunteers. Therefore, data will not be shared at this instance.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06851039
Lead sponsor
Wroclaw Medical University
Responsible party
Rafał Seredyński (Principal Investigator, Wroclaw Medical University) — Principal investigator
First posted
Feb 28, 2025
Start date
Mar 6, 2025
Primary completion
Sep 15, 2025
Completion
Sep 15, 2025
Last update
Sep 23, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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