MedPath

Determination of the optimal nutrient mix to acutely increase plasma ketones.

Conditions
glucose intolerance
Insulin resistance
10018424
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
Inclusion Criteria

- 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)

Exclusion Criteria

- 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
NameTimeMethod
<p>The primary study endpoint is plasma ketone levels (assessed via blood draws). </p><br>
Secondary Outcome Measures
NameTimeMethod
<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>
© Copyright 2025. All Rights Reserved by MedPath