The Effects of an Oral Nutritional Intervention on the Small Intestine Microbiome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorSociété des Produits Nestlé (SPN)
About this trial
This is a single-center, single-arm study, aiming at enrolling 25 healthy adult participants to evaluate chronic effects of oil. Specifically, we aim to assess the impact on gut microbiome after a one-month intervention with oil.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Males or females aged 18 to 60 years, inclusive, at enrollment.
BMI of ≥18.5 but <30 kg/m2.
Healthy, as determined based on self-reported medical history.
No planned change in diet or medical interventions during the study.
Disqualifiers
Prior or suspected gastrointestinal disease (as reported by the participant) which, in the investigator/study doctor's opinion, would lead to fistula formation, intestinal stricturing, or obstruction leading to a risk of capsule non-excretion (i.e. achalasia, active ulcer disease, eosinophilic esophagitis, Crohn's disease, ulcerates colitis, celiac disease, irritable bowel syndrome, stenosis of the GI tract).
Any prior gastrointestinal surgery (as reported by the participant) which, in the investigator/study doctor's opinion, would lead to intestinal stricturing or obstruction leading to a risk of capsule non-excretion (i.e. previous esophageal, gastric, small intestinal, or colonic surgery). Note: appendectomy, cholecystectomy, hysterectomy, oophorectomy, hemorrhoid surgery more than 3 months prior to enrollment are acceptable.
History of chronic diarrhea (defined as Bristol stool scale 5 to 7; or persistent or recurrent loose or watery stools lasting for more than 4 weeks), as reported by the participant.
History of chronic constipation (defined as having less than 3 bowel movements per week) in the past month, as reported by the participant.
Trial design
Design model
Single group
Treatments tested in this trial
Oil
Dietary supplementThe investigational product will be taken orally (10mL) once a day for the duration of 28 days (up to a maximum of 37 days).
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Interventional Product Arm - butyric acid-rich triglyceride oilExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in total bacterial abundance of the gut microbiota captured in small intestinal fluid after one-month intervention with a butyric acid-rich triglyceride oil
We aim to identify changes in the gut microbiome composition after chronic oil ingestion (one-month intervention)
Time frame
From Baseline (Day 1) through study completion (average duration: 36 days)2
Change in total bacterial abundance of the gut microbiota captured in fecal samples after one-month intervention with a butyric acid-rich triglyceride oil
We aim to identify changes in the gut microbiome composition after chronic oil ingestion (one-month intervention)
Time frame
From Baseline (Day 1) through study completion (average duration: 36 days)Secondary outcomes
1
Change in butyrate levels in the small intestinal fluid after acute ingestion of the butyric acid-rich triglyceride oil.
To assess the release of butyrate in the small intestine after acute ingestion of the butyric acid-rich triglyceride oil.
Time frame
From Baseline (Day 1) to Day 8 (after first ingestion of IP)2
Change in absolute amount of various lipid classes (e.g. triglycerides, fatty acids, etc.) in the small intestinal fluid after acute ingestion of the butyric acid-rich triglyceride oil.
To assess the change in lipids metabolism in the small intestine after acute ingestion of the butyric acid-rich triglyceride oil.
Time frame
From Baseline (Day 1) to Day 8 (after first ingestion of IP)3
Change in butyrate levels in the plasma EDTA after acute ingestion of the butyric acid-rich triglyceride oil.
To assess the release of butyrate in the small intestine measured through the absorption in the bloodstream after acute ingestion of the butyric acid-rich triglyceride oil.
Time frame
Day 8 (before and after ingestion of IP)4
Change in ketone bodies levels in the plasma EDTA after acute ingestion of the butyric acid-rich triglyceride oil.
To assess the release of ketone bodies in the small intestine measured through the absorption in the bloodstream after acute ingestion of the butyric acid-rich triglyceride oil.
Time frame
Day 8 (before and after ingestion of IP)Sponsors and contacts
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Source ClinicalTrials.gov