Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
208 participants
INTERVENTIONAL
2014-01-10
2019-08-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Heavy Resistance Training
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.
Heavy Resistance Training
Supervised Heavy Resistance Training three times weekly for 52 weeks.
Protein Whey
Two daily 20g whey protein and 10g carbohydrate supplementations for 52 weeks.
Light Intensity Training
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.
Light Intensity Training
Home-based Light Intensity Training three-five times weekly for 52 weeks.
Protein Whey
Two daily 20g whey protein and 10g carbohydrate supplementations for 52 weeks.
Protein Whey
Two daily 20g whey protein and 10g carbohydrate supplementations for 52 weeks.
Protein Whey
Two daily 20g whey protein and 10g carbohydrate supplementations for 52 weeks.
Protein Collagen
Two daily 20g collagen protein and 10g carbohydrate supplementations for 52 weeks.
Protein Collagen
Two daily 20g collagen protein and 10g carbohydrate supplementations for 52 weeks.
Carbohydrate
Two daily 30g carbohydrate supplementations for 52 weeks.
Carbohydrate
Two daily 30g carbohydrate supplementations for 52 weeks.
Interventions
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Heavy Resistance Training
Supervised Heavy Resistance Training three times weekly for 52 weeks.
Light Intensity Training
Home-based Light Intensity Training three-five times weekly for 52 weeks.
Protein Whey
Two daily 20g whey protein and 10g carbohydrate supplementations for 52 weeks.
Protein Collagen
Two daily 20g collagen protein and 10g carbohydrate supplementations for 52 weeks.
Carbohydrate
Two daily 30g carbohydrate supplementations for 52 weeks.
Eligibility Criteria
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Inclusion Criteria
* Age at least 65 years
Exclusion Criteria
* Chronic medical diseases: Diabetes mellitus, clinical knee or hip osteoarthritis, other types of arthritis or connective tissue disorders, active cancer, renal diseases, severe chronic obstructive pulmonary disease, cardiac arrhythmias or known decreased left ventricular ejection fraction, lactose or gluten intolerance, chronic inflammatory bowel diseases, non-treated hyper/hypothyroidism, dementia.
* Surgical diseases: Bone, muscle, tendon or joint injuries compromising participation in exercise regimens.
* Implanted magnetic devices incompatible with MRi-scanning.
* Weekly alcohol consumption \> 21 units (1 unit equals 4g of ethanol) for men and \> 14 for women.
* Medicine except acetylsalicylic acid, paracetamol, thyroid function hormones, statins in doses above 40mg/day or if combined with subjective myalgia, ACE-inhibitors, Angiotensin II blockers, beta-blockers, calciumantagonists, proton-pump inhibitors, thiazides, potassium-sparing diuretics and loop diuretics.
* \>1 hour of exercise weekly, except light activities such as stretching/gymnastics and bike-riding/walking as transportation.
65 Years
ALL
Yes
Sponsors
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University of Copenhagen
OTHER
Arla Foods
INDUSTRY
Bispebjerg Hospital
OTHER
Responsible Party
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Lars Holm
Ph.D. M.S.
Principal Investigators
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Rasmus Bechshøft, Ph.d. stud
Role: PRINCIPAL_INVESTIGATOR
Bispebjerg Hospital
Lars Holm, Assoc. prof.
Role: PRINCIPAL_INVESTIGATOR
Bispebjerg Hospital
Michael Kjaer, MD, Proff.
Role: PRINCIPAL_INVESTIGATOR
Bispebjerg Hospital
Søren Reitelseder, Ph.d.
Role: PRINCIPAL_INVESTIGATOR
Bispebjerg Hospital
Jacob Bülow, MD PhD stud
Role: PRINCIPAL_INVESTIGATOR
Bispebjerg Hospital
Locations
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Bispbebjerg Hospital
Copenhagen NV, , Denmark
Countries
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References
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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.
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.
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.
Other Identifiers
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H-4-2013-070
Identifier Type: -
Identifier Source: org_study_id
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