Evaluation of the Ketogenic Potential of Different Diet Supplements

• Sponsor: Université de Sherbrooke (Other)
• Overall Status: Completed
• CT.gov ID: NCT02693106
• Collaborator: (none)
• Enrollment: 13
• Location: 1
• Arm: 1
• Duration (Months): 23
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Adults	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	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Stimulating the Ketogenesis by Using Nutritional Supplements
• Study Start Date: Jul 1, 2013
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Ketogenic potential 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

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

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)	Sherbrooke	Quebec	Canada	J1H4C4

Sponsors and Collaborators

• Université de Sherbrooke

Investigators

• Principal Investigator: Stephen Cunnane, PhD, Research Centre on Aging CSSS-IUGS - CIUSSS de l'Estrie - CHUS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Université de Sherbrooke
• ClinicalTrials.gov Identifier: NCT02693106
• Other Study ID Numbers: 2014-387
• First Posted: Feb 26, 2016
• Last Update Posted: Mar 25, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Université de Sherbrooke: Ketones; Butyrate; Leucine; Octanoate; Carnitine; Medium Chain Triglycerides

Study Results

Participant Flow

Arm/Group Title	Ketogenic Potential
Arm/Group Description	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
Period Title: Overall Study
STARTED	13
COMPLETED	10
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Ketogenic Potential
Arm/Group Description	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
Overall Participants	13
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	13 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34 (4)
Sex: Female, Male (Count of Participants)
Female	10 76.9%
Male	3 23.1%
Region of Enrollment (Count of Participants)
Canada	13 100%

Outcome Measures

1. Primary Outcome

Title	Concentration of Total Plasma Ketones
Description	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.
Time Frame	4 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ketogenic Potential
Arm/Group Description	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
Measure Participants	10
CTL	-18.2 (20)
Leucine	23 (25)
Butyrate 3.6g	12.2 (44.4)
Butyrate 7.2g	68.5 (35.9)
Octanoate 5g	-3.4 (32.8)
Octanoate 10 g	39.7 (34)
Carnitine	-30 (21.4)

Adverse Events

Time Frame	8 visits of 4 hours
Adverse Event Reporting Description	no participants received the intervention if 65 g of butter fraction rich in MCT
Arm/Group Title	Control, no Supplement		5g of Leucine		3.6g de Butyrate		7.2g de Butyrate		5g d'Octanoate		10g d'Octanoate		1.95g de Carnitine
Arm/Group Description	Each visit corresponding to a standardize breakfast taken alone (control visit)followed by a period of 4-hour with multiple blood sampling.		Each visit corresponding to a standardize breakfast taken with 5g of leucine followed by a period of 4-hour with multiple blood sampling.		Each visit corresponding to a standardize breakfast taken with 3.6g of butyrate followed by a period of 4-hour with multiple blood sampling.		Each visit corresponding to a standardize breakfast taken with 7.2g of butyrate followed by a period of 4-hour with multiple blood sampling.		Each visit corresponding to a standardize breakfast taken with 5g of octanoate followed by a period of 4-hour with multiple blood sampling.		Each visit corresponding to a standardize breakfast taken with 10g of octanoate followed by a period of 4-hour with multiple blood sampling.		Each visit corresponding to a standardize breakfast taken with 1.95g of carnitine followed by a period of 4-hour with multiple blood sampling.
All Cause Mortality
	Control, no Supplement		5g of Leucine		3.6g de Butyrate		7.2g de Butyrate		5g d'Octanoate		10g d'Octanoate		1.95g de Carnitine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Control, no Supplement		5g of Leucine		3.6g de Butyrate		7.2g de Butyrate		5g d'Octanoate		10g d'Octanoate		1.95g de Carnitine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Control, no Supplement		5g of Leucine		3.6g de Butyrate		7.2g de Butyrate		5g d'Octanoate		10g d'Octanoate		1.95g de Carnitine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)		2/10 (20%)		3/10 (30%)		2/10 (20%)		3/10 (30%)		0/10 (0%)
Gastrointestinal disorders
Diarrhea	0/10 (0%)	0	0/10 (0%)	0	2/10 (20%)	2	2/10 (20%)	2	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0
gastric reflux	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	2/10 (20%)	2	3/10 (30%)	3	0/10 (0%)	0
General disorders
Headache	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	3/10 (30%)	3	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0
Nausea	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	2/10 (20%)	2	0/10 (0%)	0	2/10 (20%)	2	0/10 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.