Evaluation of the Ketogenic Potential of Different Diet Supplements

NCT02693106 | Completed Results

• 1 other identifier: 2014-387
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Adults

Keywords

Ketones; Butyrate; Leucine; Octanoate; Carnitine; Medium Chain Triglycerides

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Ketogenic potential

EXPERIMENTAL

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; Dietary Supplement: Leucine; Dietary Supplement: Butyrate -; Dietary Supplement: Butyrate +; Dietary Supplement: Octanoate -; Dietary Supplement: Octanoate +; Dietary Supplement: Carnitine; Dietary Supplement: Butter fraction

Interventions

Control DIETARY_SUPPLEMENT

Visit corresponding to a standardize breakfast taken alone (control visit) followed by a period of 4-hour with multiple blood sampling.

Also known as: CTL

Ketogenic potential

Leucine DIETARY_SUPPLEMENT

Visit corresponding to a standardize breakfast with 5 g of leucine followed by a period of 4-hour with multiple blood sampling.

Ketogenic potential

Butyrate + DIETARY_SUPPLEMENT

Visit corresponding to a standardize breakfast with 7.2 g of butyrate followed by a period of 4-hour with multiple blood sampling.

Ketogenic potential

Octanoate + DIETARY_SUPPLEMENT

Visit corresponding to a standardize breakfast with 10 g of octanoate followed by a period of 4-hour with multiple blood sampling.

Ketogenic potential

Carnitine DIETARY_SUPPLEMENT

Visit corresponding to a standardize breakfast with 1.95 g of carnitine followed by a period of 4-hour with multiple blood sampling.

Ketogenic potential

Butter fraction DIETARY_SUPPLEMENT

Visit corresponding to a standardize breakfast with 65 g of butter fraction followed by a period of 4-hour with multiple blood sampling.

Ketogenic potential

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults aged of 18 years old or older.
• Non-smoking.

You may not qualify if:

• Diabetes or prediabetes
• Uncontrolled hypertension
• Uncontrolled thyroid function
• Taking medication that will affect lipid/glucose metabolism
• Severe infection or inflammation
• Pregnancy

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)

Sherbrooke, Quebec, J1H4C4, Canada

Location

MeSH Terms

Conditions

Ketosis

Interventions

Leucine; Butyrates; octanoic acid; Carnitine

Condition Hierarchy (Ancestors)

Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines

Results Point of Contact

• Title: Pr. Stephen Cunnane
• Organization: Université de Sherbrooke

stephen.cunnane@usherbrooke.ca

819-780-2220

Study Officials

• Stephen Cunnane, PhD

  Research Centre on Aging CSSS-IUGS - CIUSSS de l'Estrie - CHUS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: February 26, 2016
• Study Start: July 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 25, 2020
• Results First Posted: March 25, 2020

Record last verified: 2020-03

Locations

CA (1)