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AgedNCT03904433

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

A study testing Coconut oil, Caprylic acid and Sunflower oil in people with Aged, run by Karolinska Institutet at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Aged
What is being tested?
Coconut oil, Caprylic acid and Sunflower oil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteSweden
Study dates
24 Aug 2018to 12 Oct 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Daily consumption of coffee
  • Written informed consent

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Karolinska Institutet

    Solna, Stockholm County, 17176

Other trials in Sweden

About this study

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

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.

Read the 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.

Conditions
Aged
Being tested
Coconut oil, Caprylic acid, Sunflower oil, Glucose

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coconut oilOther

    Coconut oil given in coffee with cream

  • Caprylic acidDietary supplement

    Caprylic acid given in coffee with cream

  • Sunflower oilOther

    Sunflower oil given in coffee with cream

  • GlucoseOther

    Glucose dissolved in water

Study groups in NCT03904433
Study groupRoleWhat they receive
1. Sunflower oilExperimentalSunflower oil (30 g)
Receives: Other: Sunflower oil
2. Caprylic acidExperimentalCaprylic acid (20 g) + Sunflower oil (10 g)
Receives: Dietary Supplement: Caprylic acid; Other: Sunflower oil
3. Caprylic acid + GlucoseExperimentalCaprylic acid (20 g) + Sunflower oil (10 g) + Glucose (50 g)
Receives: Dietary Supplement: Caprylic acid; Other: Sunflower oil; Other: Glucose
4. Coconut oilExperimentalCoconut oil (30 g)
Receives: Other: Coconut oil
5. Coconut oil + GlucoseExperimentalCoconut oil (30 g) + Glucose (50 g)
Receives: Other: Coconut oil; Other: Glucose
6. Coconut oil + Caprylic acidExperimentalCoconut oil (30 g) + Caprylic acid (20 g)
Receives: Other: Coconut oil; Dietary Supplement: Caprylic acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Concentrations of BHB, area under the curve, 0-4 h

    BHB, measured in venous whole blood with a point-of-care meter

    Measured: 0, 15, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240 (minutes)

Secondary outcomes (6)

  1. Concentrations of total ketones

    BHB + acetoacetate, laboratory analyses from plasma

    Measured: 0, 30, 60, 120 (minutes)

  2. 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)

    Measured: 30, 60, 120 (minutes)

  3. Concentrations of BDNF / pro-BDNF

    Brain-derived neurotrophic factor (BDNF) \& pro-BDNF in serum (not measured in arm 2, 3 \& 5)

    Measured: 0, 60, 120, 240 (minutes)

  4. Concentrations of glucose

    Glucose, laboratory analysis

    Measured: 0, 60, 120, 180, 240 (minutes)

  5. 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:

    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.

    Measured: 240 (minutes)

  6. 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?

    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.

    Measured: 240 (minutes)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2019
  2. Study start24 Aug 2018
  3. Primary completion12 Oct 2018
  4. Study completion12 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03904433
Sponsor's protocol ID
CC1
Status last verified
Apr 2019
First submitted
3 Apr 2019
Last updated
3 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34489682

  • 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.

    PubMed 32351966

Questions about this trial

What is this clinical trial studying?

A study testing Coconut oil, Caprylic acid and Sunflower oil in people with Aged, run by Karolinska Institutet at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03904433, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2019.

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