Ketone Plasma Kinetics After Oral Intake of Different Ketogenic Formulae

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy Men and Women
• Intervention / Treatment: Dietary supplement: different ketogenic formulae

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bernard PhD Cuenoud; Phone Number: +41 21 924-6533; Email: Bernard.Cuenoud@nestle.com
• Study Contact Backup: Name: Nathalie PhD Piccardi; Phone Number: +41 21 785-9510; Email: Nathalie.Piccardi@rdls.nestle.com

Study Locations

• Switzerland
  • Lausanne, Switzerland
    • Nestle Clinical Innovation Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; The research product may be in a form of powder to reconstitute or in a ready-to-drink format.
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; The research product may be in a form of powder to reconstitute or in a ready-to-drink format.
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; The research product may be in a form of powder to reconstitute or in a ready-to-drink format.
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; The research product may be in a form of powder to reconstitute or in a ready-to-drink format.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Investigators: Principal Investigator: Pamela Sun, Société des Produits Nestlé (SPN)

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 16, 2021
• First Submitted That Met QC Criteria: September 16, 2021
• First Posted (Actual): September 27, 2021

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 1803NR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No