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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
| |
| 4 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2.5% protein | Dietary Supplement | 2.5% |
| |
| Measure | Description | Time Frame |
|---|---|---|
| KetoIndex - plasma concentration | KetoIndex calculated as area under the plasma concentration versus time curve (AUC) of total ketones (BHB + AcA) over 4 hours after MCT-based products consumption / quantity of ingested MCTs in gram. | 4 hours |
| total ketones (BHB+ACA) - Half-life time | Half-Life time (T ½) calculated as time to reach half of Area under the plasma concentration versus time curve (AUC)-infinite of total ketones (BHB+ACA) after MCT-based products consumption. | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Ketones blood kinetic - Plasma concentration | (Total Ketones, BHB, AcA) measured as plasma concentration versus time curve (AUCs) after MCT-based products consumption | 4 hours |
| Ketones blood kinetics - peak plasma concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maurice Beaumont, dr | Nestec Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Metabolic Unit | Lausanne | Canton of Vaud | 1000 | Switzerland |
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| ID | Term |
|---|---|
| D011506 | Proteins |
| D062408 | Breakfast |
| ID | Term |
|---|---|
| D000602 | Amino Acids, Peptides, and Proteins |
| D062407 | Meals |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
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| protein 5% |
| Dietary Supplement |
5% |
|
| protein 10% | Dietary Supplement | 10% |
|
| protein 15% | Dietary Supplement | 15% |
|
| A2: Peptamen 1.5 Vanilla without Breakfast | Dietary Supplement | Peptamen withoug breakfast |
|
| B2: only breakfast (no product) | Dietary Supplement | only breakfast |
|
| C2: 5% protein with breakfast | Dietary Supplement | C2: 5% protein consumed with breakfast |
|
| D2: 5% protein 30 min before breakfast | Dietary Supplement | D2: 5% protein consumed 30 min before breakfast |
|
Peak Plasma Concentration (Cmax) of total Ketones, BHB, AcA MCT-based products consumption.
| 4 hours |
| Ketones blood kinetics - time to maximum concentration | Time to maximum concentration (Tmax) of total Ketones, BHB, AcA MCT-based products consumption. | 4 hours |
| Ketones blood kinetics - Half-life time | Half-Life time (T ½) measured of total Ketones, BHB, AcA after MCT-based products consumption. | 4 hours |
| Medium chain fatty acid C8 and C10 - plasma concentration | Measure of plasma concentration versus time curve (AUCs) of Medium chain fatty acid C8 and C10 after MCT-based products consumption | 4 hours |
| Medium chain fatty acid C8 and C10 - concentration | Maximum plasma Concentration (Cmax) of Medium chain fatty acid C8 and C10 (and their metabolites) after MCT-based products consumption | 4 hours |
| Medium chain fatty acid C8 and C10 - Time to maximum concentration | Time to maximum concentration (Tmax) of Medium chain fatty acid C8 and C10 (and their metabolites) after MCT-based products consumption | 4 hours |
| Medium chain fatty acid C8 and C10 - Half-life time | Half-Life time (T ½) measured of Medium chain fatty acid C8 and C10 (and their metabolites) after MCT-based products consumption | 4 hours |
| Glucose and insulin - plasma concentration | Measure of plasma concentration versus time curve (AUCs) of glucose and insuline after MCT-based products consumption | 4 hours |
| Glucose and insulin - peak plasma concentration | Measure of maximum plasma concentration (Cmax) of glucose and insuline after MCT-based products consumption | 4 hours |
| Glucose and insulin - time to maximum concentration | Measure of time to maximum concentration (Tmax) of glucose and insuline after MCT-based products consumption | 4 hours |
| Glucose and insulin- Half-life time | Measure of Half-life time (T½) of of glucose and insuline after MCT-based products consumption | 4 hours |
| Gastro-intestinal tolerability assessment | Gastro-intestinal tolerability assessment with visual analogue scales for each symptom of interest (i.e.) 1) Abdominal discomfort , 2) Decreased appetite, 3) Gastric reflux, 4) Nausea, 5) Diarrhea, 6) Headache). Each scale are from 0 (better outcome) to 100 (worst outcome). | 24 hours |
| Adverse event incidence | Adverse events incidence | 24 hours |
| D010829 |
| Physiological Phenomena |
| D019602 | Food and Beverages |