Ketone Plasma Kinetics After Oral Intake of Different Ketogenic Formulae

Study Overview
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Brief Summary
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This research project aims at evaluating the effect of various ketone precursors and their formulations on blood ketone level after oral intake. Evaluation of the GI tolerability of the various formula will be also evaluated.

Official Title
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Ketone Plasma Kinetics After Oral Intake of Different Ketogenic Formulae

Conditions
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Healthy Men and Women

Intervention / Treatment
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* Dietary Supplement: different ketogenic formulae


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy men and women, based on the screening visit and medical history, BMI in the normal and overweight range 18.5 ≤ BMI ≤ 27; Able to understand and sign informed consent form. Exclusion Criteria: Any medication possibly impacting the postprandial glucose and insulin response (based on anamnesis), Any medication impacting dietary fat absorption and metabolism, 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, 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, Family or hierarchical relationships with Clinical Innovation Lab at Nestlé Research, Lausanne, Switzerland, Volunteer who cannot be expected to comply with the protocol, Smokers unable to stop for the day of the visit.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Each testing cycle design will be either a complete or partial cross-over.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ketone Precursor Formula 1<br>Formula 1 (in each cycle, up to 4 formula will be tested) Ketone precursors formula (powder to reconstitute in drinking water, or in a ready-to-drink format). | Dietary Supplement: different ketogenic formulae<br>* The research product may be in a form of powder to reconstitute or in a ready-to-drink format.<br>|
| Active Comparator: Ketone Precursor Formula 2<br>Ketone precursors formula (powder to Reconstitute in drinking water, or in a ready-to-drink format). | Dietary Supplement: different ketogenic formulae<br>* The research product may be in a form of powder to reconstitute or in a ready-to-drink format.<br>|
| Active Comparator: Ketone Precursor Formula 3<br>Ketone precursors formula (powder to Reconstitute in drinking water, or in a ready-to-drink format) | Dietary Supplement: different ketogenic formulae<br>* The research product may be in a form of powder to reconstitute or in a ready-to-drink format.<br>|
| Active Comparator: Ketone Precursor Formula 4<br>Ketone precursors formula (powder to Reconstitute in drinking water, or in a ready-to-drink format), or placebo | Dietary Supplement: different ketogenic formulae<br>* The research product may be in a form of powder to reconstitute or in a ready-to-drink format.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ketone Plasma Kinetics After Oral Intake of Different Ketogenic Formulae | Incremental area under the curve of total blood ketones | 0 (baseline) to 4 hours after products consumption |