Clinical trial NCT02034760: Counteracting Age-related Loss of Skeletal Muscle Mass
Official title: Counteracting Age-related Loss of Skeletal Muscle Mass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Muscle Loss
Keywords: Frailty
Ageing
Protein supplementation
Protein quality
Gut microbiota
Metabolome
Exercise training
Sarcopenia
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Arla Foods
First posted: 2014-01-13
Enrollment: 208
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Healthy, independently living
* Age at least 65 years

Exclusion Criteria:

* Subjects dependent on help/nursing etc.
* 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.

Primary outcomes:
measure: Change in muscle cross sectional area
timeFrame: Baseline, 6, 12, and 18 months
Secondary outcomes:
measure: Change in quadriceps muscle isometric strength
timeFrame: Baseline, 6, 12 and 18 months
measure: Change in quadriceps muscle isokinetic strength
timeFrame: Baseline, 6, 12 and 18 months
measure: Change in leg extension muscle power
timeFrame: Baseline, 6, 12 and 18 months
measure: Change from baseline in muscle structure and signalling
timeFrame: Baseline and 12 months
measure: Change in gut microbiota composition.
timeFrame: Baseline, 6 and 12 months (and 18 months on a subset of samples).
measure: Change in faecal metabolome.
timeFrame: Baseline, 6 and 12 months (and 18 months on a subset of samples).
measure: Change in faecal metabolome.
timeFrame: Baseline, 6 and 12 months (and 18 months on a subset of samples).
measure: Change in plasma metabolome.
timeFrame: Baseline, 6 and 12 months (and 18 months on a subset of samples).
measure: Change in plasma metabolome.
timeFrame: Baseline, 6 and 12 months (and 18 months on a subset of samples).
measure: Change in 30 s chair stand
timeFrame: Baseline, 6, 12 and 18 months
measure: Change in whole body composition and bone mineral density
timeFrame: Baseline, 6, 12 and 18 months
Other outcomes:
measure: Change in blood parameters and anthropometry
timeFrame: Baseline, 6, 12 and 18 months
measure: Change in gait speed
timeFrame: Baseline, 6, 12 and 18 months
measure: Change in grip strength
timeFrame: Baseline, 6, 12 and 18 months
measure: Change in tendon biomechanical properties
timeFrame: Baseline and 12 months
measure: Questionnaires and interviews
timeFrame: Baseline and 12 months
measure: Change in daily macronutrient intake
timeFrame: Baseline, 1.5/2 and 12 months
measure: Change in habitual activity
timeFrame: Baseline, 6, 12 and 18 months
measure: Questionnaire on acceptance of supplements
timeFrame: Weekly for first 3 months and every 3rd month until 12 months
measure: Change in glucose handling measured by a OGTT
timeFrame: Baseline and 12 months
measure: Change in vitamin B12 and related metabolite concentrations in blood
timeFrame: Baseline, 6, 12 and 18 months
Locations:
city: Copenhagen NV
country: Denmark
facility: Bispbebjerg Hospital
Study officials:
affiliation: Bispebjerg Hospital
name: Rasmus Bechshøft, Ph.d. stud
role: PRINCIPAL_INVESTIGATOR
affiliation: Bispebjerg Hospital
name: Lars Holm, Assoc. prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bispebjerg Hospital
name: Michael Kjaer, MD, Proff.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bispebjerg Hospital
name: Søren Reitelseder, Ph.d.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bispebjerg Hospital
name: Jacob Bülow, MD PhD stud
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.