The Effects of an Oral Nutritional Intervention on the Small Intestine Microbiome

NCT07439718 | Recruiting

• 1 other identifier: 2504CLI
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Microbiome Composition; Microbiome

Outcome Measures

Primary Outcomes (2)

• 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)

  From Baseline (Day 1) through study completion (average duration: 36 days)

• 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)

  From Baseline (Day 1) through study completion (average duration: 36 days)

Secondary Outcomes (9)

• Change in butyrate levels in the small intestinal fluid after acute ingestion of the butyric acid-rich triglyceride oil.

  From Baseline (Day 1) to Day 8 (after first ingestion of IP)

• 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.

  From Baseline (Day 1) to Day 8 (after first ingestion of IP)

• Change in butyrate levels in the plasma EDTA after acute ingestion of the butyric acid-rich triglyceride oil.

  Day 8 (before and after ingestion of IP)

• Change in ketone bodies levels in the plasma EDTA after acute ingestion of the butyric acid-rich triglyceride oil.

  Day 8 (before and after ingestion of IP)

• Change in total bacterial abundance of the microbiota of saliva after one-month intervention with butyric acid-rich triglyceride oil.

  From Baseline (Day 1) through study completion (average duration: 36 days)

Study Arms (1)

Interventional Product Arm - butyric acid-rich triglyceride oil

EXPERIMENTAL

Butyric acid-rich triglyceride oil, commercially available

Dietary Supplement: Oil

Interventions

Oil DIETARY_SUPPLEMENT

The investigational product will be taken orally (10mL) once a day for the duration of 28 days (up to a maximum of 37 days).

Interventional Product Arm - butyric acid-rich triglyceride oil

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Willing to collect fecal samples and retrieve sampling capsules from feces.
• Able to understand and to sign a written informed consent prior to study enrollment.
• Willing and able to comply with the requirements for participation in this study.

You may not qualify if:

• 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.
• Any history of obstructive symptoms in the previous 3 months prior to enrollment, as reported by the participant.
• Diagnosis of any organic motility disorder, including gastroparesis, intestinal pseudo-obstruction, systemic sclerosis, Ogilvie's syndrome, as reported by the participant.
• Diagnosis of any malabsorption disorder (i.e. malabsorption syndrome, lactose malabsorption), as reported by the participant.
• History of oropharyngeal dysphagia or other swallowing disorder with a risk of aspiration of the capsule, as reported by the participant.
• Any concurrent cancer diagnosis, as reported by the participant.
• Any cancer treatment within the past year, as reported by the participant.
• History of known abdominal or pelvic radiation treatment at any time in the past, as reported by the participant.
• Any cardiovascular, endocrine, renal, liver, or other chronic disease likely to affect motility (i.e. diabetes mellitus, concurrent biliary tract stones, kidney stones, etc.), as reported by the participant.
• Antibacterial/antifungal therapy in the past 3 months prior to enrolment, as reported by the participant.
• Use of any medications or supplements that could substantially alter gastrointestinal acidity, motor function, or microbiota (e.g. proton pump inhibitors, H2 receptor antagonists, opioids, prokinetics, anticholinergics, laxatives) in the past 4 weeks prior to enrollment, as reported by the participant.
• Underwent colon cleanse or bowel preparation in the 2 weeks prior to enrollment, as reported by the participant.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Clinical Lab

Lausanne, 1000, Switzerland

RECRUITING

MeSH Terms

Interventions

Oils

Intervention Hierarchy (Ancestors)

Lipids

Central Study Contacts

Marie-Pierre Pélissou

CONTACT

+41 21 785 86 39; marie-pierre.pelissou@rd.nestle.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: February 27, 2026
• Study Start: February 23, 2026
• Primary Completion: May 31, 2026
• Study Completion: May 31, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

CH (1)