Active, not recruitingNCT05058157Updated Oct 17, 2023

Ketone Plasma Kinetics After Oral Intake of Different Ketogenic Formulae

An interventional study of different ketogenic formulae in Healthy Men and Women, sponsored by Société des Produits Nestlé (SPN). Active, not recruiting at 1 site in Switzerland. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-17.

Sponsored by Société des Produits Nestlé (SPN) · Not applicable, Interventional, and Treatment

From the registry’s dates

Primary completion was expected by Dec 2023, 2 years 10 months ago, but the record still lists the study as active, not recruiting.

Phase: Not applicable
Study type: Interventional
Enrollment: 20
Allocation: Randomized
Ages: 18 Years to 50 Years
Sex: All

Study summary

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.

Conditions studied

Healthy Men and Women

In context

Lead sponsor

Société des Produits Nestlé (SPN) is the lead sponsor of 314 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 20 participants (actual)

Study arms

Active comparator
Ketone Precursor Formula 1
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
Active comparator
Ketone Precursor Formula 2
Ketone precursors formula (powder to Reconstitute in drinking water, or in a ready-to-drink format).
Dietary Supplement: different ketogenic formulae
Active comparator
Ketone Precursor Formula 3
Ketone precursors formula (powder to Reconstitute in drinking water, or in a ready-to-drink format)
Dietary Supplement: different ketogenic formulae
Active comparator
Ketone Precursor Formula 4
Ketone precursors formula (powder to Reconstitute in drinking water, or in a ready-to-drink format), or placebo
Dietary Supplement: different ketogenic formulae

Interventions

Dietary supplementdifferent ketogenic formulae
The research product may be in a form of powder to reconstitute or in a ready-to-drink format.

What researchers measure

Primary outcomes

Ketone Plasma Kinetics After Oral Intake of Different Ketogenic Formulae
Incremental area under the curve of total blood ketones
Time frame: 0 (baseline) to 4 hours after products consumption

Study locations

1 site

Nestlé Clinical Innovation Lab
Lausanne, Switzerland

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05058157
Lead sponsor: Société des Produits Nestlé (SPN)
Responsible party: Sponsor
First posted: Sep 27, 2021
Start date: Aug 21, 2023
Primary completion: Dec 2023 (estimated)
Completion: Dec 2024 (estimated)
Last update: Oct 17, 2023

Study contacts

Pamela Sun

principal investigator · Société des Produits Nestlé (SPN)

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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