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This study will investigate the effect of providing a daily ketogenic nutritional supplement in the evening for a prolonged time (4 weeks) to induce a mild ketogenic state during the night in healthy elderly (60-80 years), overweight/obese (BMI: 25-35 kg/m2) individuals with low physical activity, on 24h rhythmicity in energy metabolism as compared to a non-ketogenic, isocaloric control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketogenic nutritional supplement | Experimental | Daily ketogenic nutritional supplement for 4 weeks |
|
| non-ketogenic, isocaloric control | Placebo Comparator | Daily control for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ketogenic nutritional Supplement | Dietary Supplement | Daily ketogenic nutritional supplement for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Delta respiratory exchange ratio (from 23:00 till 04:00) | Measured with indirect calorimetry | Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control |
| Measure | Description | Time Frame |
|---|---|---|
| Skeletal mitochondrial function | Measured in muscle biopsy | Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control |
| Measure | Description | Time Frame |
|---|---|---|
| Protein and gene markers of skeletal muscle metabolism | Measured in muscle biopsy | Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control |
| Metabolic blood markers |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Merel Timmermans, MSc | Contact | 0031 88 3887793 | merel.timmermans@maastrichtuniversity.nl | |
| Joris Hoeks, Dr. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Joris Hoeks, Dr. | Maastricht University | Principal Investigator |
| Peter Joris, Dr. | Maastricht University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University | Recruiting | Maastricht | Netherlands |
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| non-ketogenic, isocaloric control | Dietary Supplement | Daily control for 4 weeks |
|
Measured in blood samples
| Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control |
| Interstitial ketone levels | Measured with a continuous ketone monitor | Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control |
| Interstitial glucose levels | Measured with a continuous glucose monitor | Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control |
| Whole body substrate utilization | Measured with indirect calorimetry | Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control |
| Whole body energy expenditure | Measured with indirect calorimetry | Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control |
| Physical performances | Measured with 6-minute walk test, chair-stand-test, and handgrip strength test | Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control |
| Cognitive performance | Measured using Cambridge Neuropsychological Test Automated Battery (CANTAB) and cerebral perfusion measured with transcranial doppler ultrasound | Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control |
| Other perceivable benefits: microvasculature | Measured with retinal images | Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control |
| Other perceivable benefits: sleep quality | Measured with sleep quality questionnaires | Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control |
| Body composition | Measured with BodPod | Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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