Quantification of Ketosis After Intake of Coconut Oil and Caprylic Acid-With and Without Glucose-After a 12-hour Fast

May 2, 2019 updated by: Miia Kivipelto, Karolinska Institutet

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Stockholm
      • Solna, Stockholm, Sweden, 17176
        • Karolinska Institutet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

61 years to 71 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1. Sunflower oil
Sunflower oil (30 g)
Other: Sunflower oil
Sunflower oil given in coffee with cream
Experimental: 2. Caprylic acid
Caprylic acid (20 g) + Sunflower oil (10 g)
Other: Sunflower oil
Sunflower oil given in coffee with cream
Dietary supplement: Caprylic acid
Caprylic acid given in coffee with cream
Experimental: 3. Caprylic acid + Glucose
Caprylic acid (20 g) + Sunflower oil (10 g) + Glucose (50 g)
Other: Sunflower oil
Sunflower oil given in coffee with cream
Dietary supplement: Caprylic acid
Caprylic acid given in coffee with cream
Other: Glucose
Glucose dissolved in water
Experimental: 4. Coconut oil
Coconut oil (30 g)
Other: Coconut oil
Coconut oil given in coffee with cream
Experimental: 5. Coconut oil + Glucose
Coconut oil (30 g) + Glucose (50 g)
Other: Glucose
Glucose dissolved in water
Other: Coconut oil
Coconut oil given in coffee with cream
Experimental: 6. Coconut oil + Caprylic acid
Coconut oil (30 g) + Caprylic acid (20 g)
Dietary supplement: Caprylic acid
Caprylic acid given in coffee with cream
Other: Coconut oil
Coconut oil given in coffee with cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentrations of BHB, area under the curve, 0-4 h
Time Frame: 0, 15, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240 (minutes)
BHB, measured in venous whole blood with a point-of-care meter
0, 15, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240 (minutes)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentrations of total ketones
Time Frame: 0, 30, 60, 120 (minutes)
BHB + acetoacetate, laboratory analyses from plasma
0, 30, 60, 120 (minutes)
Concentrations of BHB (capillary)
Time Frame: 30, 60, 120 (minutes)
BHB, measured in capillary whole blood with a point-of-care meter, for exploratory comparisons. (not measured in arm 3 & 5)
30, 60, 120 (minutes)
Concentrations of BDNF / pro-BDNF
Time Frame: 0, 60, 120, 240 (minutes)
Brain-derived neurotrophic factor (BDNF) & pro-BDNF in serum (not measured in arm 2, 3 & 5)
0, 60, 120, 240 (minutes)
Concentrations of glucose
Time Frame: 0, 60, 120, 180, 240 (minutes)
Glucose, laboratory analysis
0, 60, 120, 180, 240 (minutes)
Self-rated satiety
Time Frame: 240 (minutes)

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:

  1. Not hungry at all.
  2. Modestly hungry. Lunch can wait.
  3. It feels like the right time for lunch. Hunger appeared during the last hour.
  4. Very hungry. Hunger appeared during the last hour.
  5. Hungry or very hungry. Hunger has been palpable for more than one hour.

Answers a, b & c will be interpreted as sufficient satiety.
240 (minutes)
Self-rated tolerance of beverage
Time Frame: 240 (minutes)

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?

  1. No
  2. Yes, minor inconvenience.
  3. Yes, moderate inconvenience.
  4. Yes, major inconvenience.

If the answer is b, c or d participants are asked to give a short description.
240 (minutes)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentrations of insulin
Time Frame: 0, 60, 90, 120, 240 (minutes)
Not measured at minutes 60, 90 & 120 in arm 1, 2, 4, 6
0, 60, 90, 120, 240 (minutes)
Concentrations of glucagon
Time Frame: 0, 60, 90, 120, 240 (minutes)
Not measured at minutes 60, 90 & 120 in arm 1, 2, 4, 6
0, 60, 90, 120, 240 (minutes)
Concentrations of HbA1c
Time Frame: 0 (minutes)
Only measured at the first testing session
0 (minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Miia Kivipelto, Professor, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2018

Primary Completion (Actual)

October 12, 2018

Study Completion (Actual)

October 12, 2018

Study Registration Dates

First Submitted

April 3, 2019

First Submitted That Met QC Criteria

April 3, 2019

First Posted (Actual)

April 5, 2019

Study Record Updates

Last Update Posted (Actual)

May 3, 2019

Last Update Submitted That Met QC Criteria

May 2, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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