Counteracting Age-related Loss of Skeletal Muscle Mass

NCT02034760 | Completed DMC

• 1 other identifier: H-4-2013-070
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia; Muscle Loss

Keywords

Frailty; Ageing; Protein supplementation; Protein quality; Gut microbiota; Metabolome; Exercise training; Sarcopenia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• Change in quadriceps muscle isometric strength

  Baseline, 6, 12 and 18 months

• Change in quadriceps muscle isokinetic strength

  Baseline, 6, 12 and 18 months

• Change in leg extension muscle power

  Baseline, 6, 12 and 18 months

• Change from baseline in muscle structure and signalling

  Baseline and 12 months

• Change in gut microbiota composition.

  Baseline, 6 and 12 months (and 18 months on a subset of samples).

Other Outcomes (10)

• Change in blood parameters and anthropometry

  Baseline, 6, 12 and 18 months

• Change in gait speed

  Baseline, 6, 12 and 18 months

• Change in grip strength

  Baseline, 6, 12 and 18 months

Study Arms (5)

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.

Procedure: Heavy Resistance Training; Dietary Supplement: Protein Whey

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.

Procedure: Light Intensity Training; Dietary Supplement: Protein Whey

Protein Whey

ACTIVE COMPARATOR

Two daily 20g whey protein and 10g carbohydrate supplementations for 52 weeks.

Dietary Supplement: Protein Whey

Protein Collagen

ACTIVE COMPARATOR

Two daily 20g collagen protein and 10g carbohydrate supplementations for 52 weeks.

Dietary Supplement: Protein Collagen

Carbohydrate

PLACEBO COMPARATOR

Two daily 30g carbohydrate supplementations for 52 weeks.

Dietary Supplement: Carbohydrate

Interventions

Heavy Resistance Training PROCEDURE

Supervised Heavy Resistance Training three times weekly for 52 weeks.

Heavy Resistance Training

Light Intensity Training PROCEDURE

Home-based Light Intensity Training three-five times weekly for 52 weeks.

Light Intensity Training

Protein Whey DIETARY_SUPPLEMENT

Two daily 20g whey protein and 10g carbohydrate supplementations for 52 weeks.

Heavy Resistance Training; Light Intensity Training; Protein Whey

Protein Collagen DIETARY_SUPPLEMENT

Two daily 20g collagen protein and 10g carbohydrate supplementations for 52 weeks.

Protein Collagen

Carbohydrate DIETARY_SUPPLEMENT

Two daily 30g carbohydrate supplementations for 52 weeks.

Carbohydrate

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Healthy, independently living
• Age at least 65 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• University of Copenhagen: collaborator
• Arla Foods: collaborator

Study Sites (1)

Bispbebjerg Hospital

Copenhagen NV, 2400, Denmark

Location

Related Publications (3)

• 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.

  PMID: 37463344 DERIVED

• 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.

  PMID: 33564844 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.

  PMID: 27507236 DERIVED

MeSH Terms

Conditions

Sarcopenia; Muscular Atrophy; Frailty

Interventions

Whey; Carbohydrates

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D. M.S.

Study Record Dates

• First Submitted: January 10, 2014
• First Posted: January 13, 2014
• Study Start: January 10, 2014
• Primary Completion: June 1, 2019
• Study Completion: August 1, 2019
• Last Updated: November 29, 2019

Record last verified: 2019-11

Locations

DK (1)