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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional Product Arm - butyric acid-rich triglyceride oil | Experimental | Butyric acid-rich triglyceride oil, commercially available |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Baseline (Day 1) to Day 8 (after first ingestion of IP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie-Pierre Pélissou | Contact | +41 21 785 86 39 | marie-pierre.pelissou@rd.nestle.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Lab | Recruiting | Lausanne | 1000 | Switzerland |
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| ID | Term |
|---|---|
| D009821 | Oils |
| ID | Term |
|---|---|
| D008055 | Lipids |
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| 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. |
| 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. | 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. | 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. | 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. | 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. | To identify changes in the oral microbiome composition after one-month intervention with butyric acid-rich triglyceride oil. | From Baseline (Day 1) through study completion (average duration: 36 days) |
| Change in total GSRS scores after one-month intervention with butyric acid-rich triglyceride oil | To assess the tolerability of butyric acid-rich triglyceride oil intake. | From Baseline (Day 1) through study completion (average duration: 36 days) |
| Change in GSRS scores in each of the 5 domains (reflux, abdominal pain, indigestion, diarrhea, constipation) after one-month intervention with butyric acid-rich triglyceride oil | To assess the tolerability of butyric acid-rich triglyceride oil intake. | From Baseline (Day 1) through study completion (average duration: 36 days) |
| Change in the Bristol stool scale after one-month intervention with butyric acid-rich triglyceride oil | To assess the tolerability of butyric acid-rich triglyceride oil intake. | From Baseline (Day 1) through study completion (average duration: 36 days) |
| Ease of retrieval of capsules based on participant feedback | Participants will be asked to provide feedback on the ease of retreival of capsule through a simple questionnaire, and this will be used to assess the feasibility of incorporating the use of the SIMBA capsule in clinical trials. | From Baseline (Day 1) through study completion (average duration: 36 days) |