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NCT Number: NCT06851039

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

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wroclaw Medical University

Wroclaw, Lower Silesian Voivodeship, 50-367, Poland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Potato starch supplementation

Dietary 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 supplementation

Dietary 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 supplementation

Dietary Supplement

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Wroclaw Medical University

Other

Registry information

Official study title

Effects of the Resistant Starch and Sodium Butyrate Supplementation on the Respiratory and Cardiovascular Autonomic Control in Humans

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 28, 2025
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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