The Importance of Additional Protein to Benefit More From Training During and After Hospitalization

NCT02717819 | Completed

• 2 other identifiers: EFFECT.PEPOP.2016H-16018240
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of the study is to investigate if an increased protein intake, in the form of a protein-enriched, milk-based supplement, can enhance the beneficial effect of resistance training, offered during hospitalization and 12 weeks post discharge, in older patients. This will in part be evaluated from measures of muscle strength, muscle mass and physical functioning. Also, the study population's acceptance of the intervention product will be assessed along with measures related to 'cost-effectiveness'. A sub-study will be performed in a sub-group (n=30) to investigate if bio-impedance analysis (BIA) correlates with Dual-Energy X-ray absorptiometry (DXA) at single time points, and to see if it is possible to track changes in lean body mass. In addition, the reliability of the bio-impedance analyzer will be evaluated. Also, the prevalence and classification of sarcopenia will be assessed at baseline, and correlations to nutritional status will be investigated (n=120).

Conditions

Sarcopenia

Keywords

Sarcopenia; Muscular atrophy; Frailty; Acute illness; Ageing; Protein supplementation; Whey protein; Resistance training; Strength training

Outcome Measures

Primary Outcomes (1)

• Change in 30-s chair stand performance

  Number of stand-ups from a chair in 30 seconds (modified version, help from armrests are allowed).

  Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge

Secondary Outcomes (18)

• Total lean body mass

  Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge

• Appendicular lean body mass

  Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge

• Trunk lean body mass

  Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge

• Change in hand grip strength

  Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge

• Change in 4 m gait speed

  Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge

Other Outcomes (14)

• Lean body mass (sub group n=30)

  Baseline (while admitted to hospital) and 12 weeks post discharge

• Fat mass (sub group n=30)

  Baseline (while admitted to hospital) and 12 weeks post discharge

• Reliability of bio-impedance analyzer in sub-group (n=30)

  Baseline (while admitted to hospital)

Study Arms (2)

Resistance training and protein

EXPERIMENTAL

Daily supervised resistance training offered while hospitalized, and encouragement of self-training 4 times per week for duration of 12 weeks after discharge (standardized training program, which will be monitered). Daily intake of 2 x 125 ml protein-enriched, milk-based supplements (whey protein), in the same period (additional \~25 g protein and 1953 kJ per day). Daily vitamin D supplements.

Dietary Supplement: Protein; Other: Resistance training; Dietary Supplement: Vitamin D

Resistance training and placebo

PLACEBO COMPARATOR

Daily supervised resistance training offered while hospitalized, and encouragement of self-training 4 times per week for duration of 12 weeks after discharge (standardized training program, which will be monitered). Daily intake of 2 x125 ml iso-energetic placebo-supplements, in the same period. Daily vitamin D supplements.

Dietary Supplement: Placebo; Other: Resistance training; Dietary Supplement: Vitamin D

Interventions

Protein DIETARY_SUPPLEMENT

Daily intake of supplement

Also known as: Protein-enriched, milk-based supplement (whey protein)

Resistance training and protein

Placebo DIETARY_SUPPLEMENT

Daily intake of supplement

Also known as: Iso-energetic placebo-supplement (no protein)

Resistance training and placebo

Resistance training OTHER

Resistance training (offered daily while hospitalized, and encouragement of 4 x/week as self-training after discharge)

Resistance training and placebo; Resistance training and protein

Vitamin D DIETARY_SUPPLEMENT

Aiming at a dose of 20 ug/day. 20 ug/day will be handed out to study participants who do not get vitamin D supplements from the hospital while admitted and to those who are not already taking vitamin D supplements themselfes e.g. as part of a combination tablet.

Resistance training and placebo; Resistance training and protein

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Men and women aged ≥ 70 years old
• Able to speak and understand Danish
• Expected length of stay \> 3 days (evaluated by medical staff at department)
• Ability to stand independently without walking aids
• Admitted to the medical departments of Gentofte or Herlev Hospital or Rigshospitalet-Glostrup

You may not qualify if:

• Active cancer
• Renal insufficiency (eGFR \< 30 mL/min/1.73m2)
• Cognitive impairment (not able to comprehend the purpose of the study/give informed consent)
• Terminal disease
• Exclusively receiving enteral or parenteral nutrition
• Milk/lactose allergy or intolerance
• Planning to lose weight/go on a special diet
• Planned transfer to other hospitals/departments
• Pacemaker/other implanted electrical stimulants (due to Bio-Impedance Analysis (BIA) measurements)
• Withdrawal criteria: Death during admission (does not apply to subsequent admissions)
• Withdrawal criteria: Discharge/transfer from the medical department before the intervention has started

Sponsors & Collaborators

• Forskningsenheden: lead
• University of Copenhagen: collaborator
• The Danish Dairy Research Foundation, Denmark: collaborator
• Arla Foods: collaborator
• Glostrup University Hospital, Copenhagen: collaborator
• University Hospital, Gentofte, Copenhagen: collaborator

Study Sites (3)

Copenhagen University Hospital Gentofte

Gentofte Municipality, 2820, Denmark

Location

Rigshospitalet-Glostrup

Glostrup Municipality, 2600, Denmark

Location

Copenhagen University Hospital Herlev

Herlev, 2730, Denmark

Location

Related Publications (2)

• Gade J, Beck AM, Andersen HE, Christensen B, Ronholt F, Klausen TW, Vinther A, Astrup A. Protein supplementation combined with low-intensity resistance training in geriatric medical patients during and after hospitalisation: a randomised, double-blind, multicentre trial. Br J Nutr. 2019 Nov 14;122(9):1006-1020. doi: 10.1017/S0007114519001831.

  PMID: 31337448 DERIVED

• Gade J, Beck AM, Bitz C, Christensen B, Klausen TW, Vinther A, Astrup A. Protein-enriched, milk-based supplement to counteract sarcopenia in acutely ill geriatric patients offered resistance exercise training during and after hospitalisation: study protocol for a randomised, double-blind, multicentre trial. BMJ Open. 2018 Feb 1;8(2):e019210. doi: 10.1136/bmjopen-2017-019210.

  PMID: 29391380 DERIVED

MeSH Terms

Conditions

Sarcopenia; Muscular Atrophy; Frailty

Interventions

Proteins; Whey Proteins; Resistance Training; Vitamin D

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)

Amino Acids, Peptides, and Proteins; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Arne Astrup, DMSc

  Copenhagen University Hospital at Herlev

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dietetics and Clinical Nutrition Research Unit

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: March 24, 2016
• Study Start: April 15, 2016
• Primary Completion: December 20, 2017
• Study Completion: June 20, 2018
• Last Updated: August 21, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)