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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05058157
Other study ID # 1803NR
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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