Ketone Plasma Kinetics After Oral Intake of Different Ketogenic Formulae

Healthy Men and Women Clinical Trial

Official title:

Ketone Plasma Kinetics After Oral Intake of Different Ketogenic Formulae

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05058157
• Other study ID #: 1803NR
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 21, 2023
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Société des Produits Nestlé (SPN)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Men and Women

Intervention

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

Locations

Country	Name	City	State
Switzerland	Nestlé Clinical Innovation Lab	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Société des Produits Nestlé (SPN)

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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