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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02693106
Other study ID # 2014-387
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2013
Est. completion date June 2015

Study information

Verified date March 2020
Source Université de Sherbrooke
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Evaluate the capacity of different dietary supplements to increase ketone production in healthy adults.


Description:

The aim of this study is to evaluate the capacity of different dietary supplements to increase ketone production in healthy adults. Each supplement (leucine, butyrate, octanoate, carnitine or butter fraction rich in MCT) is evaluated for a period of 4-hour during which multiple blood samples are taken in order to measure ketone production.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Healthy adults aged of 18 years old or older.

- Non-smoking.

Exclusion Criteria:

- Diabetes or prediabetes

- Uncontrolled hypertension

- Uncontrolled thyroid function

- Taking medication that will affect lipid/glucose metabolism

- Severe infection or inflammation

- Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Control
Visit corresponding to a standardize breakfast taken alone (control visit) followed by a period of 4-hour with multiple blood sampling.
Leucine
Visit corresponding to a standardize breakfast with 5 g of leucine followed by a period of 4-hour with multiple blood sampling.
Butyrate -
Visit corresponding to a standardize breakfast with 3.6 g of butyrate followed by a period of 4-hour with multiple blood sampling.
Butyrate +
Visit corresponding to a standardize breakfast with 7.2 g of butyrate followed by a period of 4-hour with multiple blood sampling.
Octanoate -
Visit corresponding to a standardize breakfast with 5 g of octanoate followed by a period of 4-hour with multiple blood sampling.
Octanoate +
Visit corresponding to a standardize breakfast with 10 g of octanoate followed by a period of 4-hour with multiple blood sampling.
Carnitine
Visit corresponding to a standardize breakfast with 1.95 g of carnitine followed by a period of 4-hour with multiple blood sampling.
Butter fraction
Visit corresponding to a standardize breakfast with 65 g of butter fraction followed by a period of 4-hour with multiple blood sampling.

Locations

Country Name City State
Canada Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS) Sherbrooke Quebec

Sponsors (1)

Lead Sponsor Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Concentration of Total Plasma Ketones Difference from Time 0 in Total ketones = acetoacetate (umol/L) + beta-hydroxybutyrate (umol/L) Time 0 is when the participants arrived, after a 12 hours fast, i.e. before the breakfast.
Plasma was collected every 30 minutes for 4 hours immediately following breakfast (where supplements were taken).
Results are the mean of plasma ketones measured every 30 minutes ( i.e. total of 9 plasma samples) for the 4 hour period.
For each time point, the difference form time 0 has been made. So this is the mean of the difference from time 0 in total ketones.
Data were not collected for the 'Intervention 8: 65 g of butter fraction rich in MCT' supplement.
4 hours
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