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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03904433
Other study ID # CC1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 24, 2018
Est. completion date October 12, 2018

Study information

Verified date April 2019
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. Blood ketones and other biomarkers will be measured during 4 hours.


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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date October 12, 2018
Est. primary completion date October 12, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Coconut oil
Coconut oil given in coffee with cream
Dietary Supplement:
Caprylic acid
Caprylic acid given in coffee with cream
Other:
Sunflower oil
Sunflower oil given in coffee with cream
Glucose
Glucose dissolved in water

Locations

Country Name City State
Sweden Karolinska Institutet Solna Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Other Concentrations of insulin Not measured at minutes 60, 90 & 120 in arm 1, 2, 4, 6 0, 60, 90, 120, 240 (minutes)
Other Concentrations of glucagon Not measured at minutes 60, 90 & 120 in arm 1, 2, 4, 6 0, 60, 90, 120, 240 (minutes)
Other Concentrations of HbA1c Only measured at the first testing session 0 (minutes)
Primary 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 Concentrations of total ketones BHB + acetoacetate, laboratory analyses from plasma 0, 30, 60, 120 (minutes)
Secondary 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) 30, 60, 120 (minutes)
Secondary Concentrations of BDNF / pro-BDNF Brain-derived neurotrophic factor (BDNF) & pro-BDNF in serum (not measured in arm 2, 3 & 5) 0, 60, 120, 240 (minutes)
Secondary Concentrations of glucose Glucose, laboratory analysis 0, 60, 120, 180, 240 (minutes)
Secondary 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:
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.
240 (minutes)
Secondary 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?
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.
240 (minutes)
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