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Completed

NCT Number: NCT03904433

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

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.

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Key information

Conditions

Aged

Age range

65 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet

Solna, Stockholm County, 17176, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coconut oil

Other

Coconut oil given in coffee with cream

Caprylic acid

Dietary Supplement

Caprylic acid given in coffee with cream

Sunflower Oil

Other

Sunflower oil given in coffee with cream

Glucose

Other

Glucose dissolved in water

Primary outcomes

  1. 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

Secondary outcomes

  1. Concentrations of total ketones

    Time frame: 0, 30, 60, 120 (minutes)

    BHB + acetoacetate, laboratory analyses from plasma

  2. 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)

  3. 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)

  4. Concentrations of glucose

    Time frame: 0, 60, 120, 180, 240 (minutes)

    Glucose, laboratory analysis

  5. 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:

    • 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.

  6. 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?

    • 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.

Other outcomes

  1. Concentrations of insulin

    Time frame: 0, 60, 90, 120, 240 (minutes)

    Not measured at minutes 60, 90 & 120 in arm 1, 2, 4, 6

  2. Concentrations of glucagon

    Time frame: 0, 60, 90, 120, 240 (minutes)

    Not measured at minutes 60, 90 & 120 in arm 1, 2, 4, 6

  3. Concentrations of HbA1c

    Time frame: 0 (minutes)

    Only measured at the first testing session

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 5, 2019
Registry last updated
May 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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