Evaluation of the Ketogenic Potential of Different Diet Supplements

Not Applicable

Completed

• Conditions: Healthy Adults
• Interventions: Dietary Supplement: Control; Dietary Supplement: Leucine; Dietary Supplement: Butyrate -; Dietary Supplement: Butyrate +; Dietary Supplement: Octanoate -; Dietary Supplement: Octanoate +; Dietary Supplement: Carnitine; Dietary Supplement: Butter fraction

• Registration Number: NCT02693106
• Lead Sponsor: Université de Sherbrooke

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2013-07
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Study First Submitted: 2016-02-23
• Study First Submitted QC: 2016-02-23
• Study First Posted: 2016-02-26
• Results First Submitted: 2017-08-27
• Status Verified: 2020-03
• Results First Submitted QC: 2020-03-24
• Last Update Submitted: 2020-03-24
• Results First Posted: 2020-03-25
• Last Update Posted: 2020-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ketogenic potential	Carnitine	Each participant has to go through a total of 8 visits, each visit corresponding to a standardize breakfast taken alone (control visit) or with one of the dietary supplements evaluated followed by a period of 4-hour with multiple blood sampling. Intervention 1: Control; no supplement Intervention 2: 5 g of leucine Intervention 3: 3.6 g of butyrate Intervention 4: 7.2 g of butyrate Intervention 5: 5 g of octanoate Intervention 6: 10 g of octanoate Intervention 7: 1.95 g of carnitine Intervention 8: 65 g of butter fraction rich in MCT
Ketogenic potential	Leucine	Each participant has to go through a total of 8 visits, each visit corresponding to a standardize breakfast taken alone (control visit) or with one of the dietary supplements evaluated followed by a period of 4-hour with multiple blood sampling. Intervention 1: Control; no supplement Intervention 2: 5 g of leucine Intervention 3: 3.6 g of butyrate Intervention 4: 7.2 g of butyrate Intervention 5: 5 g of octanoate Intervention 6: 10 g of octanoate Intervention 7: 1.95 g of carnitine Intervention 8: 65 g of butter fraction rich in MCT
Ketogenic potential	Octanoate +	Each participant has to go through a total of 8 visits, each visit corresponding to a standardize breakfast taken alone (control visit) or with one of the dietary supplements evaluated followed by a period of 4-hour with multiple blood sampling. Intervention 1: Control; no supplement Intervention 2: 5 g of leucine Intervention 3: 3.6 g of butyrate Intervention 4: 7.2 g of butyrate Intervention 5: 5 g of octanoate Intervention 6: 10 g of octanoate Intervention 7: 1.95 g of carnitine Intervention 8: 65 g of butter fraction rich in MCT
Ketogenic potential	Butyrate -	Each participant has to go through a total of 8 visits, each visit corresponding to a standardize breakfast taken alone (control visit) or with one of the dietary supplements evaluated followed by a period of 4-hour with multiple blood sampling. Intervention 1: Control; no supplement Intervention 2: 5 g of leucine Intervention 3: 3.6 g of butyrate Intervention 4: 7.2 g of butyrate Intervention 5: 5 g of octanoate Intervention 6: 10 g of octanoate Intervention 7: 1.95 g of carnitine Intervention 8: 65 g of butter fraction rich in MCT
Ketogenic potential	Butyrate +	Each participant has to go through a total of 8 visits, each visit corresponding to a standardize breakfast taken alone (control visit) or with one of the dietary supplements evaluated followed by a period of 4-hour with multiple blood sampling. Intervention 1: Control; no supplement Intervention 2: 5 g of leucine Intervention 3: 3.6 g of butyrate Intervention 4: 7.2 g of butyrate Intervention 5: 5 g of octanoate Intervention 6: 10 g of octanoate Intervention 7: 1.95 g of carnitine Intervention 8: 65 g of butter fraction rich in MCT
Ketogenic potential	Butter fraction	Each participant has to go through a total of 8 visits, each visit corresponding to a standardize breakfast taken alone (control visit) or with one of the dietary supplements evaluated followed by a period of 4-hour with multiple blood sampling. Intervention 1: Control; no supplement Intervention 2: 5 g of leucine Intervention 3: 3.6 g of butyrate Intervention 4: 7.2 g of butyrate Intervention 5: 5 g of octanoate Intervention 6: 10 g of octanoate Intervention 7: 1.95 g of carnitine Intervention 8: 65 g of butter fraction rich in MCT
Ketogenic potential	Control	Each participant has to go through a total of 8 visits, each visit corresponding to a standardize breakfast taken alone (control visit) or with one of the dietary supplements evaluated followed by a period of 4-hour with multiple blood sampling. Intervention 1: Control; no supplement Intervention 2: 5 g of leucine Intervention 3: 3.6 g of butyrate Intervention 4: 7.2 g of butyrate Intervention 5: 5 g of octanoate Intervention 6: 10 g of octanoate Intervention 7: 1.95 g of carnitine Intervention 8: 65 g of butter fraction rich in MCT
Ketogenic potential	Octanoate -	Each participant has to go through a total of 8 visits, each visit corresponding to a standardize breakfast taken alone (control visit) or with one of the dietary supplements evaluated followed by a period of 4-hour with multiple blood sampling. Intervention 1: Control; no supplement Intervention 2: 5 g of leucine Intervention 3: 3.6 g of butyrate Intervention 4: 7.2 g of butyrate Intervention 5: 5 g of octanoate Intervention 6: 10 g of octanoate Intervention 7: 1.95 g of carnitine Intervention 8: 65 g of butter fraction rich in MCT

Primary Outcome Measures

Name	Time	Method
Concentration of Total Plasma Ketones	4 hours	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.

Trial Locations

Locations (1)

Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS); 🇨🇦 Sherbrooke, Quebec, Canada