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

Aged Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03904433
• Other study ID #: CC1
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Aged

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)