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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
| Arla Foods | INDUSTRY |
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Up to approximately 205 (dependent on drop-out rate) healthy elderly individuals (at least 65 years old) are recruited as subjects.
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=30-35), Light Intensity Training (N=30-35), Protein Whey (N=40-50), Protein Collagen (N=40-50) and Carbohydrate (N=30-35). 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 6 and 12 months of intervention and again at 18 months (after 6 months of follow up).
The primary outcome is change in quadriceps muscle cross sectional area from Baseline to 12 months of intervention.
The primary hypothesis is that by applying the intension-to-treat analysis, the Light Intensity Training group will increase quadriceps muscle cross sectional area just as much as the Heavy Resistance Training group. The two training groups will gain more muscle mass than the Protein Whey group, which will gain more than the Protein Collagen and the Carbohydrate groups that will loose quadriceps muscle cross sectional areas.
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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 20g whey protein and 10g 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 20g whey protein and 10g carbohydrate supplementations for 52 weeks. |
|
| Protein Whey | Active Comparator | Two daily 20g whey protein and 10g carbohydrate supplementations for 52 weeks. |
|
| Protein Collagen | Active Comparator | Two daily 20g collagen protein and 10g carbohydrate supplementations for 52 weeks. |
|
| Carbohydrate | Placebo Comparator | Two daily 30g 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 |
|---|---|---|
| Change in muscle cross sectional area | MRi scans of quadriceps muscle cross sectional area. The primary time interval for assessment of the primary outcome measure is from Baseline to 12 months intervention. The statistical evaluation of the primary outcome measure is done by applying a two way ANOVA test comparing groups: 1) Heavy Resistance Training vs. Light Intensity Training vs. Protein Whey and 2) Protein Whey vs. Protein Collagen vs. Carbohydrate. The statistical evaluation will be performed first as an intension-to-treat analysis and subsequently as a per-protocol analysis. Assessments are performed at 6 months as well and at 18 months (after 6 months follow up). Changes in muscle cross sectional area will be evaluated over 6 months from Baseline to 6 months, from 6 to 12 months, and from 12 months to 18 months. | Baseline, 6, 12, and 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quadriceps muscle isometric strength | Isometric unilateral quadriceps force and rate of force development measured in the isokinetic dynamometer device (KinCom) during knee extension at the knee angle 70 deg (with 0 degrees being fully extended). | Baseline, 6, 12 and 18 months |
| Change in quadriceps muscle isokinetic strength |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood parameters and anthropometry | Blood: HbA1c, plasma lipids, vitamin B12 and related metabolites. Anthropometry: Weight, abdominal circumference. Blood pressure. | Baseline, 6, 12 and 18 months |
| Change in gait speed |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rasmus Bechshøft, Ph.d. stud | Bispebjerg Hospital | Principal Investigator |
| Lars Holm, Assoc. prof. | Bispebjerg Hospital | Principal Investigator |
| Michael Kjaer, MD, Proff. | Bispebjerg Hospital | Principal Investigator |
| Søren Reitelseder, Ph.d. | Bispebjerg Hospital | Principal Investigator |
| Jacob Bülow, MD PhD stud | Bispebjerg Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispbebjerg Hospital | Copenhagen NV | 2400 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37463344 | Derived | Mertz KH, Reitelseder S, Rasmussen MA, Bulow J, Hojfeldt G, Jensen M, Hjulmand M, Lindberg J, Kramer MU, Bechshoft R, Holm L. Changes in Muscle Mass and Strength During Follow-Up After One-Year Resistance Training Interventions in Older Adults. J Strength Cond Res. 2023 Oct 1;37(10):2064-2070. doi: 10.1519/JSC.0000000000004517. Epub 2023 Jul 17. | |
| 33564844 |
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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 20g whey protein and 10g carbohydrate supplementations for 52 weeks. |
|
| Protein Collagen | Dietary Supplement | Two daily 20g collagen protein and 10g carbohydrate supplementations for 52 weeks. |
|
| Carbohydrate | Dietary Supplement | Two daily 30g carbohydrate supplementations for 52 weeks. |
|
Unilateral knee extension (concentric) strength measured in the KinCom device at an angular velocity of 60 degrees/sec. |
| Baseline, 6, 12 and 18 months |
| Change in leg extension muscle power | Unilateral leg extension power measured in the Powerrig device. | Baseline, 6, 12 and 18 months |
| Change from baseline in muscle structure and signalling | From muscle biopsies muscle fiber type distribution and size, capillary density, satellite cell count and activity, selected gene-expression targets and protein concentrations will be assessed. | Baseline and 12 months |
| Change in gut microbiota composition. | Molecular biology based methods incl. high throughput sequencing aided by classical, culture-based microbiological techniques as needed. | Baseline, 6 and 12 months (and 18 months on a subset of samples). |
| Change in faecal metabolome. | NMR of faecal samples. | Baseline, 6 and 12 months (and 18 months on a subset of samples). |
| Change in faecal metabolome. | Gas chromatography mass spectrometry (GCMS) of faecal samples. | Baseline, 6 and 12 months (and 18 months on a subset of samples). |
| Change in plasma metabolome. | Nuclear magnetic resonance (NMR) of plasma samples. | Baseline, 6 and 12 months (and 18 months on a subset of samples). |
| Change in plasma metabolome. | GCMS of plasma samples. | Baseline, 6 and 12 months (and 18 months on a subset of samples). |
| Change in 30 s chair stand | Number of stand-ups from a chair in 30 seconds. | Baseline, 6, 12 and 18 months |
| Change in whole body composition and bone mineral density | Body composition (fat mass, lean mass and bone mass) evaluated by whole-body dual energy x-ray absorptiometry (DXA)-scanning. Bone mineral density at vertebrae L2-L4 and collum femoris evaluated by DXA-scanning. | Baseline, 6, 12 and 18 months |
400 m gait speed.
| Baseline, 6, 12 and 18 months |
| Change in grip strength | Isometric hand grip strength. | Baseline, 6, 12 and 18 months |
| Change in tendon biomechanical properties | Measurements of tendon biomechanical properties. | Baseline and 12 months |
| Questionnaires and interviews | Short Form 36, Pittsburgh Sleep Scale Questionnaire, questionnaires on lifestyle, life history, supplement palatability and interviews and observations of subjects with focus on changes in lifestyle as result of intervention. | Baseline and 12 months |
| Change in daily macronutrient intake | 3-days self-report of food and beverage intake. | Baseline, 1.5/2 and 12 months |
| Change in habitual activity | Evaluated by 4 days continuous monitoring by a pedometer device (ActivPal). | Baseline, 6, 12 and 18 months |
| Questionnaire on acceptance of supplements | Questionnaires on acceptance of supplementation | Weekly for first 3 months and every 3rd month until 12 months |
| Change in glucose handling measured by a OGTT | Completion of an oral glucose tolerance test (OGTT) | Baseline and 12 months |
| Change in vitamin B12 and related metabolite concentrations in blood | Concentration of total B12, B12 available for cells (holoTC), and methylmalonate (MMA). | Baseline, 6, 12 and 18 months |
| Mertz KH, Reitelseder S, Bechshoeft R, Bulow J, Hojfeldt G, Jensen M, Schacht SR, Lind MV, Rasmussen MA, Mikkelsen UR, Tetens I, Engelsen SB, Nielsen DS, Jespersen AP, Holm L. The effect of daily protein supplementation, with or without resistance training for 1 year, on muscle size, strength, and function in healthy older adults: A randomized controlled trial. Am J Clin Nutr. 2021 Apr 6;113(4):790-800. doi: 10.1093/ajcn/nqaa372. |
| 27507236 | Derived | 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 |