Ketone Plasma Kinetics After Oral Intake Of Different MCT

Nestlé

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: D2: 5% protein 30 min before breakfast; Dietary Supplement: C2: 5% protein with breakfast; Dietary Supplement: B2: only breakfast (no product); Dietary Supplement: A2: Peptamen 1.5 Vanilla without Breakfast; Dietary Supplement: protein 5%; Dietary Supplement: protein 10%; Dietary Supplement: 2.5% protein; Dietary Supplement: protein 15%

Study type: Interventional

Funder types: Industry

Identifiers

NCT03603782

18.03.NRC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 4 patient groups

1

Experimental group

Treatment:

Dietary Supplement: protein 15%

Dietary Supplement: protein 10%

Dietary Supplement: protein 5%

Dietary Supplement: B2: only breakfast (no product)

Dietary Supplement: D2: 5% protein 30 min before breakfast

Dietary Supplement: C2: 5% protein with breakfast

2

Experimental group

Treatment:

Dietary Supplement: protein 15%

Dietary Supplement: protein 10%

Dietary Supplement: 2.5% protein

Dietary Supplement: A2: Peptamen 1.5 Vanilla without Breakfast

Dietary Supplement: D2: 5% protein 30 min before breakfast

Dietary Supplement: C2: 5% protein with breakfast

3

Experimental group

Treatment:

Dietary Supplement: protein 15%

Dietary Supplement: 2.5% protein

Dietary Supplement: protein 5%

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 group

Treatment:

Dietary Supplement: protein 10%

Dietary Supplement: 2.5% protein

Dietary Supplement: protein 5%

Dietary Supplement: A2: Peptamen 1.5 Vanilla without Breakfast

Dietary Supplement: B2: only breakfast (no product)

Dietary Supplement: C2: 5% protein with breakfast