Ketone Plasma Kinetics After Oral Intake Of Different MCT

Société des Produits Nestlé (SPN)20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

2.5% proteinDIETARY_SUPPLEMENT

2.5%

protein 5%DIETARY_SUPPLEMENT

protein 10%DIETARY_SUPPLEMENT

10%

protein 15%

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age: 18-50 years 2. Healthy men and women, based on the medical screening visit and medical history 3. BMI in the normal and overweight range 18.5 ≤ BMI ≤ 27. 4. Able to understand and to sign a written informed consent prior to study entry Exclusion Criteria: 1. Any medication possibly impacting the postprandial glucose and insulin response (on anamnesis, to the opinion of the medical expert) 2. Any medication impacting dietary fat absorption and metabolism or impacting postprandial glucose and insulin response, to the opinion of the medical expert 3. Pregnancy (on anamnesis) and/or lactation 4. Known food allergy and food intolerance 5. Individuals undergoing either dietary or exercise mediated weight loss program prescribed by a health care professional 6. Individuals under ketogenic diets, or taking regular ketones products such as MCT, ketone esters or ketone salts (calcium, magnesium, sodium, potassium) 7. 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 8. Having given blood within the last month, or willing to make a blood donation until one month following the end of the study 9. Participant having a hierarchical link with the research team members 10. Not expected to follow the protocol. 11. Smokers unable to stop for the day of the visit

Locations (1)

Metabolic Unit

Lausanne, Canton of Vaud, Switzerland

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 4 hours

Secondary Outcomes

Ketones blood kinetic - Plasma concentration

(Total Ketones, BHB, AcA) measured as plasma concentration versus time curve (AUCs) after MCT-based products consumption

Time frame: 4 hours

Ketones blood kinetics - peak plasma concentration

Peak Plasma Concentration (Cmax) of total Ketones, BHB, AcA MCT-based products consumption.

Time frame: 4 hours

Ketones blood kinetics - time to maximum concentration

Time to maximum concentration (Tmax) of total Ketones, BHB, AcA MCT-based products consumption.

Time frame: 4 hours

Ketones blood kinetics - Half-life time

Half-Life time (T ½) measured of total Ketones, BHB, AcA after MCT-based products consumption.

Time frame: 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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.