Effects of the Short-Chain Fatty Acids-Targeted Dietary Interventions on the Selected Autonomic Functions in Humans
NCT ID: NCT06851039
Last Updated: 2025-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
14 participants
INTERVENTIONAL
2025-03-06
2025-09-15
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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potato starch
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.
sodium butyrate
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.
accessible maze starch
Accessible starch supplementation
Participants will receive the accessible (digestible) waxy maze starch as placebo.
Interventions
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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.
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.
Accessible starch supplementation
Participants will receive the accessible (digestible) waxy maze starch as placebo.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
40 Years
ALL
Yes
Sponsors
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Wroclaw Medical University
OTHER
Responsible Party
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Rafał Seredyński
Principal Investigator
Locations
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Wroclaw Medical University
Wroclaw, Lower Silesian Voivodeship, Poland
Countries
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Other Identifiers
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STM.A090.20.110
Identifier Type: -
Identifier Source: org_study_id
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