Ketone Plasma Kinetics After Oral Intake of Different Ketogenic Formulae

NCT05058157 | Unknown

• 1 other identifier: 1803NR
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Men and Women

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Ketone Precursor Formula 1

ACTIVE COMPARATOR

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

Ketone Precursor Formula 2

ACTIVE COMPARATOR

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

Dietary Supplement: different ketogenic formulae

Ketone Precursor Formula 3

ACTIVE COMPARATOR

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

Dietary Supplement: different ketogenic formulae

Ketone Precursor Formula 4

ACTIVE COMPARATOR

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

Dietary Supplement: different ketogenic formulae

Interventions

different ketogenic formulae DIETARY_SUPPLEMENT

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

Ketone Precursor Formula 1; Ketone Precursor Formula 2; Ketone Precursor Formula 3; Ketone Precursor Formula 4

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Nestlé Clinical Innovation Lab

Lausanne, Switzerland

Location

Study Officials

• Pamela Sun

  Société des Produits Nestlé (SPN)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Each testing cycle design will be either a complete or partial cross-over.

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: September 27, 2021
• Study Start: August 21, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: October 17, 2023

Record last verified: 2023-10

Locations

CH (1)