NCT03904433

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 24, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 5, 2019

Completed
Last Updated

May 3, 2019

Status Verified

April 1, 2019

Enrollment Period

2 months

First QC Date

April 3, 2019

Last Update Submit

May 2, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

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

    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 Outcomes (6)

  • Concentrations of total ketones

    0, 30, 60, 120 (minutes)

  • Concentrations of BHB (capillary)

    30, 60, 120 (minutes)

  • Concentrations of BDNF / pro-BDNF

    0, 60, 120, 240 (minutes)

  • Concentrations of glucose

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

  • Self-rated satiety

    240 (minutes)

  • +1 more secondary outcomes

Other Outcomes (3)

  • Concentrations of insulin

    0, 60, 90, 120, 240 (minutes)

  • Concentrations of glucagon

    0, 60, 90, 120, 240 (minutes)

  • Concentrations of HbA1c

    0 (minutes)

Study Arms (6)

1. Sunflower oil

EXPERIMENTAL

Sunflower oil (30 g)

Other: Sunflower oil

2. Caprylic acid

EXPERIMENTAL

Caprylic acid (20 g) + Sunflower oil (10 g)

Dietary Supplement: Caprylic acidOther: Sunflower oil

3. Caprylic acid + Glucose

EXPERIMENTAL

Caprylic acid (20 g) + Sunflower oil (10 g) + Glucose (50 g)

Dietary Supplement: Caprylic acidOther: Sunflower oilOther: Glucose

4. Coconut oil

EXPERIMENTAL

Coconut oil (30 g)

Other: Coconut oil

5. Coconut oil + Glucose

EXPERIMENTAL

Coconut oil (30 g) + Glucose (50 g)

Other: Coconut oilOther: Glucose

6. Coconut oil + Caprylic acid

EXPERIMENTAL

Coconut oil (30 g) + Caprylic acid (20 g)

Other: Coconut oilDietary Supplement: Caprylic acid

Interventions

Coconut oil given in coffee with cream

4. Coconut oil5. Coconut oil + Glucose6. Coconut oil + Caprylic acid
Caprylic acidDIETARY_SUPPLEMENT

Caprylic acid given in coffee with cream

2. Caprylic acid3. Caprylic acid + Glucose6. Coconut oil + Caprylic acid

Sunflower oil given in coffee with cream

1. Sunflower oil2. Caprylic acid3. Caprylic acid + Glucose
GlucoseOTHER

Glucose dissolved in water

3. Caprylic acid + Glucose5. Coconut oil + Glucose

Eligibility Criteria

Age65 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Daily consumption of coffee
  • Written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Solna, Stockholm County, 17176, Sweden

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Interventions

Coconut Oiloctanoic acidSunflower OilGlucose

Intervention Hierarchy (Ancestors)

Dietary FatsFatsLipidsPlant OilsOilsPlant PreparationsBiological ProductsComplex MixturesHexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Miia Kivipelto, Professor

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD, PhD

Study Record Dates

First Submitted

April 3, 2019

First Posted

April 5, 2019

Study Start

August 24, 2018

Primary Completion

October 12, 2018

Study Completion

October 12, 2018

Last Updated

May 3, 2019

Record last verified: 2019-04

Locations