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Completed

NCT Number: NCT03603782

Ketone Plasma Kinetics After Oral Intake Of Different MCT

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.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Metabolic Unit

Lausanne, Canton of Vaud, 1000, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 18-50 years
  • Healthy men and women, based on the medical screening visit and medical history
  • BMI in the normal and overweight range 18.5 ≤ BMI ≤ 27.
  • Able to understand and to sign a written informed consent prior to study entry

Exclusion criteria

  • Any medication possibly impacting the postprandial glucose and insulin response (on anamnesis, to the opinion of the medical expert)
  • Any medication impacting dietary fat absorption and metabolism or impacting postprandial glucose and insulin response, to the opinion of the medical expert
  • Pregnancy (on anamnesis) and/or lactation
  • Known food allergy and food intolerance
  • Individuals undergoing either dietary or exercise mediated weight loss program prescribed by a health care professional
  • Individuals under ketogenic diets, or taking regular ketones products such as MCT, ketone esters or ketone salts (calcium, magnesium, sodium, potassium)
  • 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
  • Having given blood within the last month, or willing to make a blood donation until one month following the end of the study
  • Participant having a hierarchical link with the research team members
  • Not expected to follow the protocol.
  • Smokers unable to stop for the day of the visit

Treatment and study plan

2.5% protein

Dietary Supplement

2.5%

protein 5%

Dietary Supplement

5%

protein 10%

Dietary Supplement

10%

protein 15%

Dietary Supplement

15%

A2: Peptamen 1.5 Vanilla without Breakfast

Dietary Supplement

Peptamen withoug breakfast

B2: only breakfast (no product)

Dietary Supplement

only breakfast

C2: 5% protein with breakfast

Dietary Supplement

C2: 5% protein consumed with breakfast

D2: 5% protein 30 min before breakfast

Dietary Supplement

D2: 5% protein consumed 30 min before breakfast

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

  2. Ketones blood kinetics - peak plasma concentration

    Time frame: 4 hours

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

  3. 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. 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.

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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).

  14. Adverse event incidence

    Time frame: 24 hours

    Adverse events incidence

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Ketone Plasma Kinetics After Oral Intake Of Different MCT Formulae

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jul 27, 2018
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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