Quantification of Ketosis After Intake of Coconut Oil and Caprylic Acid-With and Without Glucose-After a 12-hour Fast
Primary Purpose
Aged
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Coconut oil
Caprylic acid
Sunflower oil
Glucose
Sponsored by
About this trial
This is an interventional basic science trial for Aged
Eligibility Criteria
Inclusion Criteria:
- Daily consumption of coffee
- Written informed consent
Exclusion Criteria:
- Smoker
- Weight <50 kg
- Diagnosed diabetes
- History of heart disease
- History of disease related to internal organs or metabolism
- Experience of "sensitive gut", or known intolerance to the test ingredients
- Medication expected to affect glucose- or lipid-metabolism
- Fasting during study or one month before
- High intensity physical activity > 3 times/week
- Dementia
- Severe psychiatric conditions
- Hb<125 g/L
- Participation in other lifestyle intervention last 6 months
Sites / Locations
- Karolinska Institutet
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
1. Sunflower oil
2. Caprylic acid
3. Caprylic acid + Glucose
4. Coconut oil
5. Coconut oil + Glucose
6. Coconut oil + Caprylic acid
Arm Description
Sunflower oil (30 g)
Caprylic acid (20 g) + Sunflower oil (10 g)
Caprylic acid (20 g) + Sunflower oil (10 g) + Glucose (50 g)
Coconut oil (30 g)
Coconut oil (30 g) + Glucose (50 g)
Coconut oil (30 g) + Caprylic acid (20 g)
Outcomes
Primary Outcome Measures
Concentrations of BHB, area under the curve, 0-4 h
BHB, measured in venous whole blood with a point-of-care meter
Secondary Outcome Measures
Concentrations of total ketones
BHB + acetoacetate, laboratory analyses from plasma
Concentrations of BHB (capillary)
BHB, measured in capillary whole blood with a point-of-care meter, for exploratory comparisons. (not measured in arm 3 & 5)
Concentrations of BDNF / pro-BDNF
Brain-derived neurotrophic factor (BDNF) & pro-BDNF in serum (not measured in arm 2, 3 & 5)
Concentrations of glucose
Glucose, laboratory analysis
Self-rated satiety
Assessed by a 5-grade categorical hunger-scale in a questionnaire at the end of each testing session. Participants will be instructed to choose the most suitable description of their hunger:
Not hungry at all.
Modestly hungry. Lunch can wait.
It feels like the right time for lunch. Hunger appeared during the last hour.
Very hungry. Hunger appeared during the last hour.
Hungry or very hungry. Hunger has been palpable for more than one hour.
Answers a, b & c will be interpreted as sufficient satiety.
Self-rated tolerance of beverage
Assessed by a 4-grade categorical scale in a questionnaire at the end of each testing session:
Did you experience any inconvenience (i.e. nausea, upset stomach), which you attribute to the beverage you were served today?
No
Yes, minor inconvenience.
Yes, moderate inconvenience.
Yes, major inconvenience.
If the answer is b, c or d participants are asked to give a short description.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03904433
Brief Title
Quantification of Ketosis After Intake of Coconut Oil and Caprylic Acid-With and Without Glucose-After a 12-hour Fast
Official Title
Quantification of Ketosis After Intake of Coconut Oil and Caprylic Acid-With and Without Glucose-After a 12-hour Fast: A 6-way Cross-over Study in Healthy Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
August 24, 2018 (Actual)
Primary Completion Date
October 12, 2018 (Actual)
Study Completion Date
October 12, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In a cross-over design, 15 participants, age 65-75, will be tested in six different arms in a randomised order. After a 12-hour fast participants will be served 2.5 dl coffee with 15 g cream + 30-50 g of different fatty acids, with or without 50 g glucose. Blood ketones and other biomarkers will be measured during 4 hours.
Detailed Description
In the metabolic state ketosis, beta-hydroxybutyrate (BHB) and acetoacetate are synthesised from fatty acids in the liver, resulting in higher circulating levels. Ketosis can be induced by fasting or adherence to a low-carb-high-fat diet, but also by intake of-at least some-medium-chain-triglycerides (MCT). MCT are built from fatty acids with a chain of 6-12 carbon atoms. Caprylic acid (C8) is well known to be ketogenic, but the effect of lauric acid (C12)-constituting about 50% of coconut oil-is less clear.
The aim of this study is to assess ketosis, as a combined effect of an extended overnight fast, and intake of coconut oil or C8, and to study how ketosis is affected by simultaneous glucose intake. Sunflower oil is used as control, expected to not break fasting ketosis, although not being ketogenic in itself. Some sunflower oil is also added to C8 to make that arm isocaloric with coconut oil, with a roughly similar proportion of MCT.
Coffee with cream will be used as a vehicle, and although coffee has been reported to be mildly ketogenic, this effect is expected to be negligible and equally distributed between arms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aged
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1. Sunflower oil
Arm Type
Experimental
Arm Description
Sunflower oil (30 g)
Arm Title
2. Caprylic acid
Arm Type
Experimental
Arm Description
Caprylic acid (20 g) + Sunflower oil (10 g)
Arm Title
3. Caprylic acid + Glucose
Arm Type
Experimental
Arm Description
Caprylic acid (20 g) + Sunflower oil (10 g) + Glucose (50 g)
Arm Title
4. Coconut oil
Arm Type
Experimental
Arm Description
Coconut oil (30 g)
Arm Title
5. Coconut oil + Glucose
Arm Type
Experimental
Arm Description
Coconut oil (30 g) + Glucose (50 g)
Arm Title
6. Coconut oil + Caprylic acid
Arm Type
Experimental
Arm Description
Coconut oil (30 g) + Caprylic acid (20 g)
Intervention Type
Other
Intervention Name(s)
Coconut oil
Intervention Description
Coconut oil given in coffee with cream
Intervention Type
Dietary Supplement
Intervention Name(s)
Caprylic acid
Intervention Description
Caprylic acid given in coffee with cream
Intervention Type
Other
Intervention Name(s)
Sunflower oil
Intervention Description
Sunflower oil given in coffee with cream
Intervention Type
Other
Intervention Name(s)
Glucose
Intervention Description
Glucose dissolved in water
Primary Outcome Measure Information:
Title
Concentrations of BHB, area under the curve, 0-4 h
Description
BHB, measured in venous whole blood with a point-of-care meter
Time Frame
0, 15, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240 (minutes)
Secondary Outcome Measure Information:
Title
Concentrations of total ketones
Description
BHB + acetoacetate, laboratory analyses from plasma
Time Frame
0, 30, 60, 120 (minutes)
Title
Concentrations of BHB (capillary)
Description
BHB, measured in capillary whole blood with a point-of-care meter, for exploratory comparisons. (not measured in arm 3 & 5)
Time Frame
30, 60, 120 (minutes)
Title
Concentrations of BDNF / pro-BDNF
Description
Brain-derived neurotrophic factor (BDNF) & pro-BDNF in serum (not measured in arm 2, 3 & 5)
Time Frame
0, 60, 120, 240 (minutes)
Title
Concentrations of glucose
Description
Glucose, laboratory analysis
Time Frame
0, 60, 120, 180, 240 (minutes)
Title
Self-rated satiety
Description
Assessed by a 5-grade categorical hunger-scale in a questionnaire at the end of each testing session. Participants will be instructed to choose the most suitable description of their hunger:
Not hungry at all.
Modestly hungry. Lunch can wait.
It feels like the right time for lunch. Hunger appeared during the last hour.
Very hungry. Hunger appeared during the last hour.
Hungry or very hungry. Hunger has been palpable for more than one hour.
Answers a, b & c will be interpreted as sufficient satiety.
Time Frame
240 (minutes)
Title
Self-rated tolerance of beverage
Description
Assessed by a 4-grade categorical scale in a questionnaire at the end of each testing session:
Did you experience any inconvenience (i.e. nausea, upset stomach), which you attribute to the beverage you were served today?
No
Yes, minor inconvenience.
Yes, moderate inconvenience.
Yes, major inconvenience.
If the answer is b, c or d participants are asked to give a short description.
Time Frame
240 (minutes)
Other Pre-specified Outcome Measures:
Title
Concentrations of insulin
Description
Not measured at minutes 60, 90 & 120 in arm 1, 2, 4, 6
Time Frame
0, 60, 90, 120, 240 (minutes)
Title
Concentrations of glucagon
Description
Not measured at minutes 60, 90 & 120 in arm 1, 2, 4, 6
Time Frame
0, 60, 90, 120, 240 (minutes)
Title
Concentrations of HbA1c
Description
Only measured at the first testing session
Time Frame
0 (minutes)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Daily consumption of coffee
Written informed consent
Exclusion Criteria:
Smoker
Weight <50 kg
Diagnosed diabetes
History of heart disease
History of disease related to internal organs or metabolism
Experience of "sensitive gut", or known intolerance to the test ingredients
Medication expected to affect glucose- or lipid-metabolism
Fasting during study or one month before
High intensity physical activity > 3 times/week
Dementia
Severe psychiatric conditions
Hb<125 g/L
Participation in other lifestyle intervention last 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miia Kivipelto, Professor
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet
City
Solna
State/Province
Stockholm
ZIP/Postal Code
17176
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
34489682
Citation
Norgren J, Daniilidou M, Kareholt I, Sindi S, Akenine U, Nordin K, Rosenborg S, Ngandu T, Kivipelto M, Sandebring-Matton A. Serum proBDNF Is Associated With Changes in the Ketone Body beta-Hydroxybutyrate and Shows Superior Repeatability Over Mature BDNF: Secondary Outcomes From a Cross-Over Trial in Healthy Older Adults. Front Aging Neurosci. 2021 Aug 20;13:716594. doi: 10.3389/fnagi.2021.716594. eCollection 2021.
Results Reference
derived
PubMed Identifier
32351966
Citation
Norgren J, Sindi S, Sandebring-Matton A, Kareholt I, Daniilidou M, Akenine U, Nordin K, Rosenborg S, Ngandu T, Kivipelto M. Ketosis After Intake of Coconut Oil and Caprylic Acid-With and Without Glucose: A Cross-Over Study in Healthy Older Adults. Front Nutr. 2020 Apr 15;7:40. doi: 10.3389/fnut.2020.00040. eCollection 2020.
Results Reference
derived
Learn more about this trial
Quantification of Ketosis After Intake of Coconut Oil and Caprylic Acid-With and Without Glucose-After a 12-hour Fast
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