Clinical trial NCT03904433: 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
Overall status: COMPLETED
Phase: NA
Conditions: Aged
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2019-04-05
Enrollment: 15
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Concentrations of BHB, area under the curve, 0-4 h
timeFrame: 0, 15, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240 (minutes)
Secondary outcomes:
measure: Concentrations of total ketones
timeFrame: 0, 30, 60, 120 (minutes)
measure: Concentrations of BHB (capillary)
timeFrame: 30, 60, 120 (minutes)
measure: Concentrations of BDNF / pro-BDNF
timeFrame: 0, 60, 120, 240 (minutes)
measure: Concentrations of glucose
timeFrame: 0, 60, 120, 180, 240 (minutes)
measure: Self-rated satiety
timeFrame: 240 (minutes)
measure: Self-rated tolerance of beverage
timeFrame: 240 (minutes)
Other outcomes:
measure: Concentrations of insulin
timeFrame: 0, 60, 90, 120, 240 (minutes)
measure: Concentrations of glucagon
timeFrame: 0, 60, 90, 120, 240 (minutes)
measure: Concentrations of HbA1c
timeFrame: 0 (minutes)
Locations:
city: Solna
country: Sweden
facility: Karolinska Institutet
state: Stockholm
Study officials:
affiliation: Karolinska Institutet
name: Miia Kivipelto, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.