Ketone Plasma Kinetics After Oral Intake of Different Ketogenic Formulae

Not Applicable

Active, not recruiting

• Conditions: Healthy Men and Women
• Interventions: Dietary Supplement: different ketogenic formulae

• Registration Number: NCT05058157
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-16
• Study First Submitted QC: 2021-09-16
• Study First Posted: 2021-09-27
• Study Start: 2023-08-21
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-16
• Last Update Posted: 2023-10-17
• Primary Completion: 2023-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ketone Precursor Formula 1	different ketogenic formulae	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).
Ketone Precursor Formula 2	different ketogenic formulae	Ketone precursors formula (powder to Reconstitute in drinking water, or in a ready-to-drink format).
Ketone Precursor Formula 3	different ketogenic formulae	Ketone precursors formula (powder to Reconstitute in drinking water, or in a ready-to-drink format)
Ketone Precursor Formula 4	different ketogenic formulae	Ketone precursors formula (powder to Reconstitute in drinking water, or in a ready-to-drink format), or placebo

Primary Outcome Measures

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

Trial Locations

Locations (1)

Nestlé Clinical Innovation Lab; 🇨🇭 Lausanne, Switzerland