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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06851039
Enrollment
14
Registered
2025-02-28
Start date
2025-03-06
Completion date
2025-09-15
Last updated
2025-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

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

Brief 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.

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.

Sponsors

Wroclaw Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Arterial baroreflex sensitivityFrom the beginning to the end of a supplementation period at 4 weeks.Arterial baroreflex sensitivity, measured with a neck chamber technique.
Peripheral chemoreflex sensitivityFrom the beginning to the end of a supplementation period at 4 weeks.Peripheral chemoreflex sensitivity, measured with the transient hypoxia test.

Secondary

MeasureTime frameDescription
Plasma short-chain fatty acidsFrom 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.

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026