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

NCT06851039 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-09-23

No results posted yet for this 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.

Conditions

  • Healthy

Interventions

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.

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.

DIETARY_SUPPLEMENT

Accessible starch supplementation

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

Sponsors & Collaborators

  • Wroclaw Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-06
Primary Completion
2025-09-15
Completion
2025-09-15

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06851039 on ClinicalTrials.gov