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

September 12, 2024 updated by: Société des Produits Nestlé (SPN)

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
KetoIndex - plasma concentration
Time Frame: 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.
4 hours
total ketones (BHB+ACA) - Half-life time
Time Frame: 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.
4 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ketones blood kinetic - Plasma concentration
Time Frame: 4 hours
(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
Time Frame: 4 hours
Peak Plasma Concentration (Cmax) of total Ketones, BHB, AcA MCT-based products consumption.
4 hours
Ketones blood kinetics - time to maximum concentration
Time Frame: 4 hours
Time to maximum concentration (Tmax) of total Ketones, BHB, AcA MCT-based products consumption.
4 hours
Ketones blood kinetics - Half-life time
Time Frame: 4 hours
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
Time Frame: 4 hours
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
Time Frame: 4 hours
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 Frame: 4 hours
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
Time Frame: 4 hours
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
Time Frame: 4 hours
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
Time Frame: 4 hours
Measure of maximum plasma concentration (Cmax) of glucose and insuline after MCT-based products consumption
4 hours
Glucose and insulin - time to maximum concentration
Time Frame: 4 hours
Measure of time to maximum concentration (Tmax) of glucose and insuline after MCT-based products consumption
4 hours
Glucose and insulin- Half-life time
Time Frame: 4 hours
Measure of Half-life time (T½) of of glucose and insuline after MCT-based products consumption
4 hours
Gastro-intestinal tolerability assessment
Time Frame: 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).
24 hours
Adverse event incidence
Time Frame: 24 hours
Adverse events incidence
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Société des Produits Nestlé (SPN)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Maurice Beaumont, dr, Nestec Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 4, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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