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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 25g MCT-based nutrient mix | Experimental |
| |
| 25g MCT-based nutrient mix + cofactors | Experimental |
| |
| non-ketogenic control | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 25g MCT-based nutrient mix | Dietary Supplement | The 25g MCT-based nutrient mix will be consumed two hours after breakfast. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma ketone levels | 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). | Testday 1, 2, and 3 |
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| Measure | Description | Time Frame |
|---|---|---|
| Whole-body fat oxidation | 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. | Testday 1, 2, and 3 |
| Energy expenditure |
Inclusion Criteria:
Exclusion Criteria:
Type 2 diabetes
Pre-diabetes based on one or a combination of the following criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Joris Hoeks, Dr. | Maastricht University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University | Maastricht | Netherlands |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| C032418 | 5,11-methenyltetrahydrohomofolate |
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| 25g MCT-based nutrient mix + cofactors | Dietary Supplement | The 25g MCT-based nutrient mix + cofactors will be consumed two hours after breakfast. |
|
| non-ketogenic control | Dietary Supplement | The non-ketogenic control will be consumed two hours after breakfast. |
|
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. |
| Testday 1, 2, and 3 |
| Metabolites in the blood | 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. | Testday 1, 2, and 3 |
| Interstitial ketone levels | 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. | Testday 1, 2, and 3 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |