Determination of the optimal nutrient mix to acutely increase plasma ketones.
- Conditions
- glucose intoleranceInsulin resistance10018424
- Registration Number
- NL-OMON56805
- Lead Sponsor
- niversiteit Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 24
- Aged 60-80 years
- Body Mass Index (BMI) 25-35 kg/m2
- Stable dietary habits (no weight loss or gain > 5 kg in the past 3 months)
- Type 2 diabetes
- Pre-diabetes based on one or a combination of the following criteria:
- Impaired Fasting Glucose (IFG): Fasting plasma glucose >= 6.1 mmol/l
and <=6.9 mmol/l
- HbA1c of 5.7-6.4%.
- Participants with active congestive heart failure and/or severe renal and or
liver insufficiency
- Uncontrolled hypertension
- Alcohol consumption of >3 servings per day for man and >2 servings per day
for woman
- Unstable body weight (weight gain or loss > 5 kg in the last 3 months)
- Previous enrolment in a clinical study with an investigational product during
the last 3 months or as
judged by the investigator which would possibly hamper our study results
- Significant food allergies/intolerance (seriously hampering study meals)
- Participants who do not want to be informed about unexpected medical findings
- Blood donation during or within 2 months prior to the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary study endpoint is plasma ketone levels (assessed via blood draws). </p><br>
- Secondary Outcome Measures
Name Time Method <p>The explorative outcomes are energy expenditure (indirect calorimetry),<br /><br>substrate utilization (indirect calorimetry), plasma glucose (blood draw),<br /><br>plasma insulin (blood draw) and continuous interstitial ketone levels<br /><br>(continuous ketone monitor). </p><br>