Clinical trial NCT03603782: Ketone Plasma Kinetics After Oral Intake Of Different MCT
Official title: Ketone Plasma Kinetics After Oral Intake Of Different MCT Formulae
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2018-07-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: KetoIndex - plasma concentration
timeFrame: 4 hours
measure: total ketones (BHB+ACA) - Half-life time
timeFrame: 4 hours
Secondary outcomes:
measure: Ketones blood kinetic - Plasma concentration
timeFrame: 4 hours
measure: Ketones blood kinetics - peak plasma concentration
timeFrame: 4 hours
measure: Ketones blood kinetics - time to maximum concentration
timeFrame: 4 hours
measure: Ketones blood kinetics - Half-life time
timeFrame: 4 hours
measure: Medium chain fatty acid C8 and C10 - plasma concentration
timeFrame: 4 hours
measure: Medium chain fatty acid C8 and C10 - concentration
timeFrame: 4 hours
measure: Medium chain fatty acid C8 and C10 - Time to maximum concentration
timeFrame: 4 hours
measure: Medium chain fatty acid C8 and C10 - Half-life time
timeFrame: 4 hours
measure: Glucose and insulin - plasma concentration
timeFrame: 4 hours
measure: Glucose and insulin - peak plasma concentration
timeFrame: 4 hours
measure: Glucose and insulin - time to maximum concentration
timeFrame: 4 hours
measure: Glucose and insulin- Half-life time
timeFrame: 4 hours
measure: Gastro-intestinal tolerability assessment
timeFrame: 24 hours
measure: Adverse event incidence
timeFrame: 24 hours
Other outcomes:
Locations:
city: Lausanne 25
country: Switzerland
facility: Metabolic Unit
state: Vaud
Study officials:
affiliation: Nestec Ltd.
name: Maurice Beaumont, dr
role: STUDY_DIRECTOR
References: