NCT06851039

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Wroclaw Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2025-03-06
• Primary completion: 2025-09-15
• Completion: 2025-09-15
• First posted: 2025-02-28
• Last updated: 2025-09-23

Locations

1 site across 1 country: Poland