Ketone Plasma Kinetics After Oral Intake Of Different MCT (KetoIndex)

Ketone Plasma Kinetics After Oral Intake Of Different MCT Formulae

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: protein 5%; Dietary supplement: protein 10%; Dietary supplement: protein 15%; Dietary supplement: B2: only breakfast (no product); Dietary supplement: C2: 5% protein with breakfast; Dietary supplement: D2: 5% protein 30 min before breakfast; Dietary supplement: 2.5% protein; Dietary supplement: A2: Peptamen 1.5 Vanilla without Breakfast

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne 25, Vaud, Switzerland, 1000
      • Metabolic Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Dietary supplement: protein 5%; 5%; Dietary supplement: protein 10%; 10%; Dietary supplement: protein 15%; 15%; Dietary supplement: B2: only breakfast (no product); only breakfast; Dietary supplement: C2: 5% protein with breakfast; C2: 5% protein consumed with breakfast; Dietary supplement: D2: 5% protein 30 min before breakfast; D2: 5% protein consumed 30 min before breakfast
Experimental: 2	Dietary supplement: protein 10%; 10%; Dietary supplement: protein 15%; 15%; Dietary supplement: C2: 5% protein with breakfast; C2: 5% protein consumed with breakfast; Dietary supplement: D2: 5% protein 30 min before breakfast; D2: 5% protein consumed 30 min before breakfast; Dietary supplement: 2.5% protein; 2.5%; Dietary supplement: A2: Peptamen 1.5 Vanilla without Breakfast; Peptamen withoug breakfast
Experimental: 3	Dietary supplement: protein 5%; 5%; Dietary supplement: protein 15%; 15%; Dietary supplement: B2: only breakfast (no product); only breakfast; Dietary supplement: D2: 5% protein 30 min before breakfast; D2: 5% protein consumed 30 min before breakfast; Dietary supplement: 2.5% protein; 2.5%; Dietary supplement: A2: Peptamen 1.5 Vanilla without Breakfast; Peptamen withoug breakfast
Experimental: 4	Dietary supplement: protein 5%; 5%; Dietary supplement: protein 10%; 10%; Dietary supplement: B2: only breakfast (no product); only breakfast; Dietary supplement: C2: 5% protein with breakfast; C2: 5% protein consumed with breakfast; Dietary supplement: 2.5% protein; 2.5%; Dietary supplement: A2: Peptamen 1.5 Vanilla without Breakfast; Peptamen withoug breakfast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Investigators: Study Director: Maurice Beaumont, dr, Nestec Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2018
• Primary Completion (Actual): May 31, 2024
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: June 14, 2018
• First Submitted That Met QC Criteria: July 19, 2018
• First Posted (Actual): July 27, 2018

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 12, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 18.03.NRC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No