Ketone Plasma Kinetics After Oral Intake Of Different MCT

NCT ID: NCT03603782

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-04

Study Completion Date

2024-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

protein 5%

Intervention Type DIETARY_SUPPLEMENT

5%

protein 10%

Intervention Type DIETARY_SUPPLEMENT

10%

protein 15%

Intervention Type DIETARY_SUPPLEMENT

15%

B2: only breakfast (no product)

Intervention Type DIETARY_SUPPLEMENT

only breakfast

C2: 5% protein with breakfast

Intervention Type DIETARY_SUPPLEMENT

C2: 5% protein consumed with breakfast

D2: 5% protein 30 min before breakfast

Intervention Type DIETARY_SUPPLEMENT

D2: 5% protein consumed 30 min before breakfast

2

Group Type EXPERIMENTAL

2.5% protein

Intervention Type DIETARY_SUPPLEMENT

2.5%

protein 10%

Intervention Type DIETARY_SUPPLEMENT

10%

protein 15%

Intervention Type DIETARY_SUPPLEMENT

15%

A2: Peptamen 1.5 Vanilla without Breakfast

Intervention Type DIETARY_SUPPLEMENT

Peptamen withoug breakfast

C2: 5% protein with breakfast

Intervention Type DIETARY_SUPPLEMENT

C2: 5% protein consumed with breakfast

D2: 5% protein 30 min before breakfast

Intervention Type DIETARY_SUPPLEMENT

D2: 5% protein consumed 30 min before breakfast

3

Group Type EXPERIMENTAL

2.5% protein

Intervention Type DIETARY_SUPPLEMENT

2.5%

protein 5%

Intervention Type DIETARY_SUPPLEMENT

5%

protein 15%

Intervention Type DIETARY_SUPPLEMENT

15%

A2: Peptamen 1.5 Vanilla without Breakfast

Intervention Type DIETARY_SUPPLEMENT

Peptamen withoug breakfast

B2: only breakfast (no product)

Intervention Type DIETARY_SUPPLEMENT

only breakfast

D2: 5% protein 30 min before breakfast

Intervention Type DIETARY_SUPPLEMENT

D2: 5% protein consumed 30 min before breakfast

4

Group Type EXPERIMENTAL

2.5% protein

Intervention Type DIETARY_SUPPLEMENT

2.5%

protein 5%

Intervention Type DIETARY_SUPPLEMENT

5%

protein 10%

Intervention Type DIETARY_SUPPLEMENT

10%

A2: Peptamen 1.5 Vanilla without Breakfast

Intervention Type DIETARY_SUPPLEMENT

Peptamen withoug breakfast

B2: only breakfast (no product)

Intervention Type DIETARY_SUPPLEMENT

only breakfast

C2: 5% protein with breakfast

Intervention Type DIETARY_SUPPLEMENT

C2: 5% protein consumed with breakfast

Interventions

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2.5% protein

2.5%

Intervention Type DIETARY_SUPPLEMENT

protein 5%

5%

Intervention Type DIETARY_SUPPLEMENT

protein 10%

10%

Intervention Type DIETARY_SUPPLEMENT

protein 15%

15%

Intervention Type DIETARY_SUPPLEMENT

A2: Peptamen 1.5 Vanilla without Breakfast

Peptamen withoug breakfast

Intervention Type DIETARY_SUPPLEMENT

B2: only breakfast (no product)

only breakfast

Intervention Type DIETARY_SUPPLEMENT

C2: 5% protein with breakfast

C2: 5% protein consumed with breakfast

Intervention Type DIETARY_SUPPLEMENT

D2: 5% protein 30 min before breakfast

D2: 5% protein consumed 30 min before breakfast

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maurice Beaumont, dr

Role: STUDY_DIRECTOR

Nestec Ltd.

Locations

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Metabolic Unit

Lausanne, Canton of Vaud, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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18.03.NRC

Identifier Type: -

Identifier Source: org_study_id

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