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| Name | Class |
|---|---|
| Cosun | UNKNOWN |
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The goal of this clinical trial is to test the effect of different protein-enhancement strategies versus carbohydrate control on exercise-induced muscle damage in physically active older adults. The main question it aims to answer is:
What is the effect of three different protein-enhancement strategies (whey protein (WP), mixed plant-based protein (MPP), and use of protein-rich food products (PFP) on exercise-induced muscle damage in older adults compared to isocaloric carbohydrate control?
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| animal-based protein (WP) | Experimental | Supplements and control (MPP, WP, CON) will be consumed as a drink or in a recipe for five subsequent weeks (30 g/day); four weeks preload and one week during the Four Days Marches. With this amount, we aim to increase the protein intake from <1.0g/kg/bw/d to >1.2g/kg/bw/d. Participants are allowed to dissolve the powder in a liquid of choice: we will provide several examples to the participants during the instructions. |
|
| plant-based protein (MPP) | Experimental | Supplements and control (MPP, WP, CON) will be consumed as a drink or in a recipe for five subsequent weeks (30 g/day); four weeks preload and one week during the Four Days Marches. With this amount, we aim to increase the protein intake from <1.0g/kg/bw/d to >1.2g/kg/bw/d. Participants are allowed to dissolve the powder in a liquid of choice: we will provide several examples to the participants during the instructions. |
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| protein-rich food products (PFP) | Experimental | PFP will receive digitally supported dietary intake counselling, with a focus on the use of protein-enriched food products in order to increase protein intake up to >1.2 k/kg/bw/d. |
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| control (CON) | Active Comparator | Supplements and control (MPP, WP, CON) will be consumed as a drink or in a recipe for five subsequent weeks (30 g/day); four weeks preload and one week during the Four Days Marches. With this amount, we aim to increase the protein intake from <1.0g/kg/bw/d to >1.2g/kg/bw/d. Participants are allowed to dissolve the powder in a liquid of choice: we will provide several examples to the participants during the instructions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| whey protein supplement | Dietary Supplement | Daily dosage of the supplements will be 30 gram, preferably consumed in the morning and post-exercise or prior to sleep. |
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| Measure | Description | Time Frame |
|---|---|---|
| serum creatine kinase (CK) levels | Exercise-induced muscle damage. Non-fasted venous blood samples will be drawn from the antecubital vein at each pre-exercise and post-exercise visit. Based on previous research it is expected that time-dependent exercise-induced increase in creatine kinase (CK) levels are significantly different between protein groups and control, but not within protein groups. Multiple peak post-exercise CK concentrations (several hours to up to 48h post exercise) will be compared to pre-exercise CK levels to compare the effect of different protein enhancing strategies versus carbohydrate control. | Measured 8 times in total. Once pre-single exercise, two times post-single exercise (within 2h after and around 24h after) and 2 weeks later: once pre-multiple day exercise and four times post-multiple day exercise (within 2h post-exercise) |
| Measure | Description | Time Frame |
|---|---|---|
| serum lactate dehydrogenase (LDH) levels | (Muscle) cell damage. Non-fasted venous blood samples will be drawn from the antecubital vein at each pre-exercise and post-exercise visit. | Measured 8 times in total. Once pre-single exercise, two times post-single exercise (within 2h after and around 24h after) and 2 weeks later: once pre-multiple day exercise and four times post-multiple day exercise (within 2h post-exercise) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Hopman, prof. dr. | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboudumc | Nijmegen | Gelderland | 6525GC | Netherlands |
Individual Participant Data (IPD) will be shared with researchers within the department of Medical Biosciences of the Radboud University Medical Center (Radboudumc). The department has a database of data from the past 15 years of Four Day Marches data. This research data will be added to the database. Data may be shared with other researchers upon request.
The data will become available after completion of the study and will be available for at least 15 years.
IPD will be shared with researchers within the department of Medical Biosciences of the Radboudumc. Data may be shared with other researchers upon request.
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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4-arm intervention study
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The study consists of 4 arms of which 3 arms that receive a supplement and 1 arm that will use an e-health application to enhance protein intake. The 3 supplement arms are double-blind. The e-health arm is not; since it is not possible to blind either the participants in this group neither the investigators.
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| mixed plant-based protein supplement | Dietary Supplement | Daily dosage of the supplements will be 30 gram, preferably consumed in the morning and post-exercise or prior to sleep. |
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| e-health application | Other | Daily use of an e-health application with dietary intake counselling to increase protein intake. The overall goal of these advices is to increase protein intake from <1.0g/kg/bw/d to >1.2g/kg/bw/d which is approximately 30 grams of additional protein per day (similar to the other arms of the intervention). |
|
| isocaloric carbohydrate control | Dietary Supplement | Daily dosage of the supplements will be 30 gram, preferably consumed in the morning and post-exercise or prior to sleep. |
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| muscle soreness | Muscle soreness is measured via the the Numeric Pain Scale (from 0 to 10, a higher score means more muscle soreness. | Measured 8 times in total. Once pre-single exercise, two times post-single exercise (within 2h after and around 24h after) and 2 weeks later: once pre-multiple day exercise and four times post-multiple day exercise (within 2h post-exercise) |
| muscle function | Maximal handgrip strength is measured to the nearest 0.5 kg using a hand dynamometer. The participants is seated in a chair with the shoulders adducted and neutrally rotated and elbow flexed at 90o. Three consecutive measurements of handgrip strength will be recorded. | Measured 8 times in total. Once pre-single exercise, two times post-single exercise (within 2h after and around 24h after) and 2 weeks later: once pre-multiple day exercise and four times post-multiple day exercise (within 2h post-exercise) |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |