Ketone Plasma Kinetics After Oral Intake Of Different MCT
- Conditions
- Healthy
- Interventions
- Dietary Supplement: 2.5% proteinDietary Supplement: protein 5%Dietary Supplement: protein 10%Dietary Supplement: protein 15%
- Registration Number
- NCT03603782
- Lead Sponsor
- Société des Produits Nestlé (SPN)
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Age: 18-50 years
- Healthy men and women, based on the medical screening visit and medical history
- BMI in the normal and overweight range 18.5 ≤ BMI ≤ 27.
- Able to understand and to sign a written informed consent prior to study entry
- Any medication possibly impacting the postprandial glucose and insulin response (on anamnesis, to the opinion of the medical expert)
- Any medication impacting dietary fat absorption and metabolism or impacting postprandial glucose and insulin response, to the opinion of the medical expert
- Pregnancy (on anamnesis) and/or lactation
- Known food allergy and food intolerance
- Individuals undergoing either dietary or exercise mediated weight loss program prescribed by a health care professional
- Individuals under ketogenic diets, or taking regular ketones products such as MCT, ketone esters or ketone salts (calcium, magnesium, sodium, potassium)
- Alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of bier
- Having given blood within the last month, or willing to make a blood donation until one month following the end of the study
- Participant having a hierarchical link with the research team members
- Not expected to follow the protocol.
- Smokers unable to stop for the day of the visit
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 2 2.5% protein - 1 protein 10% - 2 protein 15% - 1 protein 5% - 2 protein 10% - 3 2.5% protein - 4 protein 5% - 4 protein 10% - 1 protein 15% - 3 protein 5% - 3 protein 15% - 4 2.5% protein -
- Primary Outcome Measures
Name Time Method KetoIndex - plasma concentration 4 hours 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.
total ketones (BHB+ACA) - Half-life time 4 hours 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.
- Secondary Outcome Measures
Name Time Method Glucose and insulin- Half-life time 4 hours Measure of Half-life time (T½) of of glucose and insuline after MCT-based products consumption
Ketones blood kinetics - peak plasma concentration 4 hours Peak Plasma Concentration (Cmax) of total Ketones, BHB, AcA MCT-based products consumption.
Glucose and insulin - time to maximum concentration 4 hours Measure of time to maximum concentration (Tmax) of glucose and insuline after MCT-based products consumption
Ketones blood kinetic - Plasma concentration 4 hours (Total Ketones, BHB, AcA) measured as plasma concentration versus time curve (AUCs) after MCT-based products consumption
Glucose and insulin - peak plasma concentration 4 hours Measure of maximum plasma concentration (Cmax) of glucose and insuline after MCT-based products consumption
Ketones blood kinetics - time to maximum concentration 4 hours Time to maximum concentration (Tmax) of total Ketones, BHB, AcA MCT-based products consumption.
Ketones blood kinetics - Half-life time 4 hours Half-Life time (T ½) measured of total Ketones, BHB, AcA after MCT-based products consumption.
Medium chain fatty acid C8 and C10 - plasma concentration 4 hours Measure of plasma concentration versus time curve (AUCs) of Medium chain fatty acid C8 and C10 after MCT-based products consumption
Medium chain fatty acid C8 and C10 - concentration 4 hours Maximum plasma Concentration (Cmax) of Medium chain fatty acid C8 and C10 (and their metabolites) after MCT-based products consumption
Medium chain fatty acid C8 and C10 - Time to maximum concentration 4 hours Time to maximum concentration (Tmax) of Medium chain fatty acid C8 and C10 (and their metabolites) after MCT-based products consumption
Medium chain fatty acid C8 and C10 - Half-life time 4 hours Half-Life time (T ½) measured of Medium chain fatty acid C8 and C10 (and their metabolites) after MCT-based products consumption
Glucose and insulin - plasma concentration 4 hours Measure of plasma concentration versus time curve (AUCs) of glucose and insuline after MCT-based products consumption
Gastro-intestinal tolerability assessment 24 hours 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).
Adverse event incidence 24 hours Adverse events incidence
Trial Locations
- Locations (1)
Metabolic Unit
🇨🇭Lausanne 25, Vaud, Switzerland