Ketone Levels Achieved After Medium Chain Triglyceride (MCT) Oil

Study Overview
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Brief Summary
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Assessing Ketone levels achieved after varying doses of Medium Chain Triglyceride (MCT) oil

Detailed Description
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Assessing Ketone levels achieved after varying doses of Medium Chain Triglyceride (MCT) oil in three study populations: <65 year healthy, 65 and older healthy, and Alzheimer's disease. Each subject attends for 4 study days, receiving incrementally larger MCT doses at each visit for 0g, to 14g, to 28g to 42g.

Official Title
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Ketone Levels Achieved After Medium Chain Triglyceride (MCT) Oil

Conditions
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Pharmacokinetics

Intervention / Treatment
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* Dietary Supplement: Medium Chain Triglyceride oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult, healthy or with AD Exclusion Criteria: unable to attend all study days coconut allergy Diabetes

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Healthy, under 65 years<br>Four study days. Day 1 administered 0g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter Day 2 administered 14g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter Day 3 administered 28g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter Day 4 administered 42g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter (All MCT doses administered as a single dose at time 0) | Dietary Supplement: Medium Chain Triglyceride oil<br>* Bulletproof Braine Octane MCT oil<br>|
| Active Comparator: Healthy, over 65 years<br>Four study days. Day 1 administered 0g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter Day 2 administered 14g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter Day 3 administered 28g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter Day 4 administered 42g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter. (All MCT doses administered as a single dose at time 0) | Dietary Supplement: Medium Chain Triglyceride oil<br>* Bulletproof Braine Octane MCT oil<br>|
| Active Comparator: Alzheimer's Disease subjects<br>Four study days. Day 1 administered 0g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter Day 2 administered 14g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter Day 3 administered 28g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter Day 4 administered 42g MCT oil with baseline and hourly betahydroxybutyrate (BHB) measures (by fingerstick test) for 5 hours thereafter. (All MCT doses administered as a single dose at time 0) | Dietary Supplement: Medium Chain Triglyceride oil<br>* Bulletproof Braine Octane MCT oil<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration (Cmax) | Calculation of Cmax to varying doses in each subject and in different study arms. | 3 months | 
| Time to maximum plasma concentration (tmax) | Calculation of tmax to varying doses in each subject and in different study arms. | 3 months | 
| Area under the curve (AUC) | Calculation of AUC to varying doses in each subject and in different study arms. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight | measured in kg | 3months | 
| height | measured in cm | 3 months | 
| BMI | Calculated BMI (ht/m2) | 3months | 
| Body fat | % measured by bioimpedence scale | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MCT oil