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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
| Arla Foods | INDUSTRY |
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Up to 66 healthy elderly individuals (at least 65 years old) are recruited as subjects. They will be recruited as a subgroup to protocol ID: H-4-2013-070.
Upon inclusion, each individual will be randomized into one of the five groups stratified according to gender (M/F) and 30s chair stand (<16 OR ≥16). The five groups are: Heavy Resistance Training (N=12), Light Intensity Training (N=12), Protein Whey (N=15), Protein Collagen (N=15) and Carbohydrate (N=12). The individuals randomized into one of the supplementation groups (Protein Whey, Protein Collagen or Carbohydrate) will be blinded to the supplement content.
Assessments will be performed at Baseline (before intervention start) and after 12 months of intervention.
The primary outcomes are measures of muscle protein synthesis rate measured as the fractional synthesis rate from Baseline to 12 months of intervention.
The hypotheses are i) that basal and protein-stimulated muscle protein synthesis rates are elevated in the exercise training groups after 12 months of intervention. ii) prolonged intake of protein of different quality will improve the muscle protein synthetic response to protein intake after 12 months of intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heavy Resistance Training | Active Comparator | Heavy Resistance Training of the lower extremities three times weekly in combination with two daily 20 g whey protein and 10 g carbohydrate supplementations for 52 weeks. |
|
| Light Intensity Training | Experimental | Home-based Light Intensity Training of the lower extremities three-five times weekly in combination with two daily 20 g whey protein and 10 g carbohydrate supplementations for 52 weeks. |
|
| Protein Whey | Active Comparator | Two daily 20 g whey protein and 10 g carbohydrate supplementations for 52 weeks. |
|
| Protein Collagen | Active Comparator | Two daily 20 g collagen protein and 10 g carbohydrate supplementations for 52 weeks. |
|
| Carbohydrate | Placebo Comparator | Two daily 30 g carbohydrate supplementations for 52 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heavy Resistance Training | Procedure | Supervised Heavy Resistance Training three times weekly for 52 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Basal overnight fasted muscle protein synthesis rate. | Overnight fasting muscle protein synthesis will be measured at Baseline and after 12 months intervention by applying stable isotope amino acid tracer techniques and calculating the fractional synthesis rates. | Baseline and 12 months |
| Muscle protein synthesis rate response to protein intake from basal overnight fasted state. | Change in the response of muscle protein synthesis rate to a single intake of 20 g whey protein and 10 g carbohydrate from the basal overnight fasted state from Baseline to 12 months intervention. Statistical analysis: Outcome 1 will be subtracted outcome 2 to calculate the difference FSR at baseline and 12 month respectively. The difference at baseline will be subtracted the difference at 12 month to calculate the delta difference. This delta difference will be analyzed as a modified intention-to-treat as well as per protocol, and we will test the following groups against each other using one-way analysis of variance of the relative group changes from baseline to 12 months: (1) WHEY vs. COLL vs. CARB and (2) HRTW vs. LITW vs. WHEY | Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle protein turnover molecular signaling and gene expression | Muscle protein turnover regulation signaling and gene expression will be measured in the muscle tissue obtained for muscle protein synthesis measurements. Protein and protein activation status will be analysed by Western blot techniques. Gene expressions will be analysed by real time RT-PCR techniques. | Baseline and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rasmus L. Bechshoeft, MD | Bispebjerg Hospital | Principal Investigator |
| Lars Holm, assoc. prof. | Bispebjerg Hospital | Principal Investigator |
| Michael Kjaer, MD, prof. | Bispebjerg Hospital | Principal Investigator |
| Søren Reitelseder, PhD | Bispebjerg Hospital | Principal Investigator |
| Jacob Bülow, MD PhD stud | Bispebjerg Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispebjerg Hospital | Copenhagen NV | 2400 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37266586 | Derived | Bulow J, Khakimov B, Reitelseder S, Bechshoft R, Jensen M, van Hall G, Engelsen SB, Holm L. Effect of 1-year daily protein supplementation and physical exercise on muscle protein synthesis rate and muscle metabolome in healthy older Danes: a randomized controlled trial. Eur J Nutr. 2023 Sep;62(6):2673-2685. doi: 10.1007/s00394-023-03182-0. Epub 2023 Jun 2. | |
| 27507236 |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D009133 | Muscular Atrophy |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
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| ID | Term |
|---|---|
| D000067796 | Whey |
| D002241 | Carbohydrates |
| ID | Term |
|---|---|
| D008892 | Milk |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Light Intensity Training | Procedure | Home-based Light Intensity Training three-five times weekly for 52 weeks. |
|
| Protein Whey | Dietary Supplement | Two daily 20 g whey protein and 10 g carbohydrate supplementations for 52 weeks. |
|
| Protein Collagen | Dietary Supplement | Two daily 20 g collagen protein and 10 g carbohydrate supplementations for 52 weeks. |
|
| Carbohydrate | Dietary Supplement | Two daily 30 g carbohydrate supplementations for 52 weeks. |
|
| Bechshoft RL, Reitelseder S, Hojfeldt G, Castro-Mejia JL, Khakimov B, Ahmad HF, Kjaer M, Engelsen SB, Johansen SM, Rasmussen MA, Lassen AJ, Jensen T, Beyer N, Serena A, Perez-Cueto FJ, Nielsen DS, Jespersen AP, Holm L. Counteracting Age-related Loss of Skeletal Muscle Mass: a clinical and ethnological trial on the role of protein supplementation and training load (CALM Intervention Study): study protocol for a randomized controlled trial. Trials. 2016 Aug 9;17(1):397. doi: 10.1186/s13063-016-1512-0. |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D010335 | Pathologic Processes |
| D003611 |
| Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |