NCT02115698

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 16, 2014

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

April 20, 2023

Status Verified

April 1, 2023

Enrollment Period

5.2 years

First QC Date

April 14, 2014

Last Update Submit

April 17, 2023

Conditions

SarcopeniaMuscle Loss

Keywords

SarcopeniaFrailtyAgeingProtein supplementationProtein qualityExercise trainingMuscle protein turnover

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (1)

  • Muscle protein turnover molecular signaling and gene expression

    Baseline and 12 months

Study Arms (5)

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.

Procedure: Heavy Resistance TrainingDietary 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 20 g whey protein and 10 g carbohydrate supplementations for 52 weeks.

Procedure: Light Intensity TrainingDietary Supplement: Protein Whey

Protein Whey

ACTIVE COMPARATOR

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

Dietary Supplement: Protein Whey

Protein Collagen

ACTIVE COMPARATOR

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

Dietary Supplement: Protein Collagen

Carbohydrate

PLACEBO COMPARATOR

Two daily 30 g carbohydrate supplementations for 52 weeks.

Dietary Supplement: Carbohydrate

Interventions

Heavy Resistance TrainingPROCEDURE

Supervised Heavy Resistance Training three times weekly for 52 weeks.

Heavy Resistance Training
Light Intensity TrainingPROCEDURE

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

Light Intensity Training
Protein WheyDIETARY_SUPPLEMENT

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

Heavy Resistance TrainingLight Intensity TrainingProtein Whey
Protein CollagenDIETARY_SUPPLEMENT

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

Protein Collagen
CarbohydrateDIETARY_SUPPLEMENT

Two daily 30 g carbohydrate supplementations for 52 weeks.

Carbohydrate

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder 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 4 g of ethanol) for men and \> 14 for women
  • Medicine except acetylsalicylic acid, paracetamol, thyroid function hormones, statins in doses above 40 mg/day or if combined with subjective myalgia, ACE-inhibitors, angiotensin II blockers, beta-blockers, calciumantagonists, proton-pump inhibitors, thiazides, potassium-sparring diuretics and loop diuretics
  • hour of exercise weekly, except light activities such as stretching/gymnastics and bike-riding/walking as transportation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen NV, 2400, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 37266586DERIVED

  • 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: 27507236DERIVED

MeSH Terms

Conditions

SarcopeniaMuscular AtrophyFrailty

Interventions

WheyCarbohydrates

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

MilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Officials

  • 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

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
PhD, MS

Study Record Dates

First Submitted

April 14, 2014

First Posted

April 16, 2014

Study Start

April 1, 2014

Primary Completion

June 1, 2019

Study Completion

August 1, 2019

Last Updated

April 20, 2023

Record last verified: 2023-04

Locations

DK(1)