Ketone Plasma Kinetics After Oral Intake of Different Ketogenic Formulae

Nestlé

Status

Active, not recruiting

Conditions

Healthy Men and Women

Treatments

Dietary Supplement: different ketogenic formulae

Study type

Interventional

Funder types

Industry

Identifiers

NCT05058157

1803NR

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

20 participants in 4 patient groups

Ketone Precursor Formula 1

Active Comparator group

Description:

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).

Treatment:

Dietary Supplement: different ketogenic formulae

Ketone Precursor Formula 2

Active Comparator group

Description:

Ketone precursors formula (powder to Reconstitute in drinking water, or in a ready-to-drink format).

Treatment:

Dietary Supplement: different ketogenic formulae

Ketone Precursor Formula 3

Active Comparator group

Description:

Ketone precursors formula (powder to Reconstitute in drinking water, or in a ready-to-drink format)