Overweight and Obesity
Conditions
Brief summary
This study will be performed to determine the optimal nutrient mix (predominantly based on medium-chain triglycerides (MCTs)) to induce a mild ketogenic state in healthy older (60-80y), overweight/obese (BMI: 25-35 kg/m2) individuals. Since the aim is to induce a mild ketogenic state, a 25g MCT-based nutrient mix, a 25g MCT-based nutrient mix + cofactors, or a non-ketogenic control will be compared.
Interventions
DIETARY_SUPPLEMENT25g MCT-based nutrient mix
The 25g MCT-based nutrient mix will be consumed two hours after breakfast.
DIETARY_SUPPLEMENT25g MCT-based nutrient mix + cofactors
The 25g MCT-based nutrient mix + cofactors will be consumed two hours after breakfast.
DIETARY_SUPPLEMENTnon-ketogenic control
The non-ketogenic control will be consumed two hours after breakfast.
Sponsors
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
Yes
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) * Participants are able to provide signed and dated written informed consent prior to any study specific procedures
Exclusion criteria
* Type 2 diabetes * Pre-diabetes based on one or a combination of the following criteria: * ImpairedFastingGlucose(IFG):Fasting plasma glucose ≥ 6.1mmol/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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma ketone levels | Testday 1, 2, and 3 | The primary outcome is plasma ketone levels determined regularly over a defined time period after ingestion of the respective nutritional supplements, expressed as area under the curve (AUC). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Whole-body fat oxidation | Testday 1, 2, and 3 | An exploratory outcome is the whole-body fat oxidation / substrate utilization determined regularly over a defined time period after ingestion of the respective nutritional supplements, expressed as g/min and respiratory exchange ratio. |
| Energy expenditure | Testday 1, 2, and 3 | An exploratory outcome is the energy expenditure determined regularly over a defined time period after ingestion of the respective nutritional supplements, expressed as kJ/min. |
| Metabolites in the blood | Testday 1, 2, and 3 | An exploratory outcome is the plasma metabolite levels determined regularly over a defined time period after ingestion of the respective nutritional supplements, expressed as i.e. glucose in mmol/L, insulin in pmol/L. |
| Interstitial ketone levels | Testday 1, 2, and 3 | An exploratory outcome is the interstitial ketone levels determined regularly over a defined time period after ingestion of the respective nutritional supplements, expressed as μM. |
Countries
Netherlands
Outcome results
None listed