Ketone Plasma Kinetics After Oral Intake Of Different MCT

NCT03603782 | Completed

• 1 other identifier: 18.03.NRC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• Ketones blood kinetic - Plasma concentration

  4 hours

• Ketones blood kinetics - peak plasma concentration

  4 hours

• Ketones blood kinetics - time to maximum concentration

  4 hours

• Ketones blood kinetics - Half-life time

  4 hours

• Medium chain fatty acid C8 and C10 - plasma concentration

  4 hours

Study Arms (4)

1

EXPERIMENTAL

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

2

EXPERIMENTAL

Dietary Supplement: 2.5% protein; Dietary Supplement: protein 10%; Dietary Supplement: protein 15%; Dietary Supplement: A2: Peptamen 1.5 Vanilla without Breakfast; Dietary Supplement: C2: 5% protein with breakfast; Dietary Supplement: D2: 5% protein 30 min before breakfast

3

EXPERIMENTAL

Dietary Supplement: 2.5% protein; Dietary Supplement: protein 5%; Dietary Supplement: protein 15%; Dietary Supplement: A2: Peptamen 1.5 Vanilla without Breakfast; Dietary Supplement: B2: only breakfast (no product); Dietary Supplement: D2: 5% protein 30 min before breakfast

4

EXPERIMENTAL

Dietary Supplement: 2.5% protein; Dietary Supplement: protein 5%; Dietary Supplement: protein 10%; Dietary Supplement: A2: Peptamen 1.5 Vanilla without Breakfast; Dietary Supplement: B2: only breakfast (no product); Dietary Supplement: C2: 5% protein with breakfast

Interventions

2.5% protein DIETARY_SUPPLEMENT

2.5%

2; 3; 4

protein 5% DIETARY_SUPPLEMENT

5%

1; 3; 4

protein 10% DIETARY_SUPPLEMENT

10%

1; 2; 4

protein 15% DIETARY_SUPPLEMENT

15%

1; 2; 3

A2: Peptamen 1.5 Vanilla without Breakfast DIETARY_SUPPLEMENT

Peptamen withoug breakfast

2; 3; 4

B2: only breakfast (no product) DIETARY_SUPPLEMENT

only breakfast

1; 3; 4

C2: 5% protein with breakfast DIETARY_SUPPLEMENT

C2: 5% protein consumed with breakfast

1; 2; 4

D2: 5% protein 30 min before breakfast DIETARY_SUPPLEMENT

D2: 5% protein consumed 30 min before breakfast

1; 2; 3

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Metabolic Unit

Lausanne, Canton of Vaud, 1000, Switzerland

Location

MeSH Terms

Interventions

Proteins; Breakfast

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins; Meals; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Maurice Beaumont, dr

  Nestec Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: July 27, 2018
• Study Start: June 4, 2018
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)