Ketone Plasma Kinetics After Oral Intake Of Different MCT

Healthy Clinical Trial

Official title:

Ketone Plasma Kinetics After Oral Intake Of Different MCT Formulae

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03603782
• Other study ID #: 18.03.NRC
• Status: Completed
• Phase: N/A
• Start date: June 4, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2024
• Source: Société des Produits Nestlé (SPN)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• 2.5% protein
2.5%
• protein 5%
5%
• protein 10%
10%
• protein 15%
15%
• A2: Peptamen 1.5 Vanilla without Breakfast
Peptamen withoug breakfast
• B2: only breakfast (no product)
only breakfast
• C2: 5% protein with breakfast
C2: 5% protein consumed with breakfast
• D2: 5% protein 30 min before breakfast
D2: 5% protein consumed 30 min before breakfast

Locations

Country	Name	City	State
Switzerland	Metabolic Unit	Lausanne 25	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Société des Produits Nestlé (SPN)

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	Ketones blood kinetic - Plasma concentration	(Total Ketones, BHB, AcA) measured as plasma concentration versus time curve (AUCs) after MCT-based products consumption	4 hours
Secondary	Ketones blood kinetics - peak plasma concentration	Peak Plasma Concentration (Cmax) of total Ketones, BHB, AcA MCT-based products consumption.	4 hours
Secondary	Ketones blood kinetics - time to maximum concentration	Time to maximum concentration (Tmax) of total Ketones, BHB, AcA MCT-based products consumption.	4 hours
Secondary	Ketones blood kinetics - Half-life time	Half-Life time (T ½) measured of total Ketones, BHB, AcA after MCT-based products consumption.	4 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Glucose and insulin - plasma concentration	Measure of plasma concentration versus time curve (AUCs) of glucose and insuline after MCT-based products consumption	4 hours
Secondary	Glucose and insulin - peak plasma concentration	Measure of maximum plasma concentration (Cmax) of glucose and insuline after MCT-based products consumption	4 hours
Secondary	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
Secondary	Glucose and insulin- Half-life time	Measure of Half-life time (T½) of of glucose and insuline after MCT-based products consumption	4 hours
Secondary	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
Secondary	Adverse event incidence	Adverse events incidence	24 hours