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
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 |
Verified date | April 2019 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Karolinska Institutet | Solna | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet |
Sweden,
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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