Trials / Completed
CompletedNCT03603782
Ketone Plasma Kinetics After Oral Intake Of Different MCT
Ketone Plasma Kinetics After Oral Intake Of Different MCT Formulae
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Société des Produits Nestlé (SPN) · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
This research project is aimed at identifying the MCT formulation matrixes that provide the highest ketoindex values and extended half-life, as well as to provide an initial evaluation of the GI tolerability of the various formula. For comparison, ketones salts and esters (food grade) will be also evaluated.
Detailed description
Monocentric, open, randomized, controlled research project. The global research project will include several testing cycles as described in the figure 1. In each cycle, several research products (up to 4) will be tested on up to 20 participants in a partial or full cross-over design. Once cycle 1 is completed, blood parameters will be analysed and ketoindex will be calculated as area under the curve (AUC) of total ketones (BHB + AcA) over 4h / quantity of ingested MCTs in g. Based on ketoindex and ketones Thalf (T1/2: time to reach half of AUC-infinite of total ketones) values, new products will be developed for cycle 2.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | 2.5% protein | 2.5% |
| DIETARY_SUPPLEMENT | protein 5% | 5% |
| DIETARY_SUPPLEMENT | protein 10% | 10% |
| DIETARY_SUPPLEMENT | protein 15% | 15% |
| DIETARY_SUPPLEMENT | A2: Peptamen 1.5 Vanilla without Breakfast | Peptamen withoug breakfast |
| DIETARY_SUPPLEMENT | B2: only breakfast (no product) | only breakfast |
| DIETARY_SUPPLEMENT | C2: 5% protein with breakfast | C2: 5% protein consumed with breakfast |
| DIETARY_SUPPLEMENT | D2: 5% protein 30 min before breakfast | D2: 5% protein consumed 30 min before breakfast |
Timeline
- Start date
- 2018-06-04
- Primary completion
- 2024-05-31
- Completion
- 2024-05-31
- First posted
- 2018-07-27
- Last updated
- 2024-09-19
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT03603782. Inclusion in this directory is not an endorsement.