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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02717819
Recruitment Status : Completed
First Posted : March 24, 2016
Last Update Posted : August 21, 2018
Sponsor:
Collaborators:
University of Copenhagen
The Danish Dairy Research Foundation, Denmark
Arla Foods
Glostrup University Hospital, Copenhagen
University Hospital, Gentofte, Copenhagen
Information provided by (Responsible Party):
Forskningsenheden, Copenhagen University Hospital at Herlev

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).


Condition or disease Intervention/treatment Phase
Sarcopenia Dietary Supplement: Protein Dietary Supplement: Placebo Other: Resistance training Dietary Supplement: Vitamin D Not Applicable

Detailed Description:

Main study:

The study design is a block randomised, double-blind, placebo-controlled, multicentre intervention study. A total of 120 hospitalized older adults, above 70 years, will be recruited consecutively from the medical departments of three Hospitals in the Capital Region of Denmark (n=40 each place).

Participants will be randomized into two groups - one group receives protein-enriched, milk-based supplements and the other group receives iso-energetic placebo products. Both groups participate in the same standardized resistance training program, and will be blinded to the supplement content. One training session consists of three exercises of the lower extremities (3 sets of 10 repetitions, pursuing an intensity of 8-12 repetition maximum (RM)). While admitted, supervised resistance training is offered daily. After discharge, the participants are encouraged to perform the same program as self-training four times per week.To ensure progression (or regression if necessary) the participants receive follow-up home visits by a physiotherapist, and thus after discharge the participants are closely monitored. All participants, irrespective of allocation, will get a daily vitamin D supplement.

The study duration for each participant starts while admitted to hospital and lasts until 12 weeks after discharge. Endpoint assessments will be performed at baseline (> 72-h after admission to hospital), after discharge (> 72-h) and 12 weeks (± 2 days) after discharge. A few endpoints will be collected during follow-up (6 months post intervention). Data will be collected by study investigators blinded to the allocation of the participants.

Sub-study: 'Validation of a portable bio-impedance analyzer in a population of older adults ≥ 70 years for the assessment of muscle mass and changes in muscle mass over time' A sub-study will be performed to investigate if the portable InBody-230 BIA correlate with DXA at single time points in 30 hospitalized older people ≥ 70 years, and to see if it is possible to track changes in LBM during the 12-week intervention. Total LBM, total fat mass, and percent LBM will be measured and compared as well as appendicular and trunk LBM. In addition, the reliability of the portable bio-impedance analyzer will be evaluated by assessing the degree of agreement between two subsequent measurements. In continuation of recruitment to the primary study, a subset of participants (n=30) will be asked if they want to participate in this sub-study, irrespective of their allocation in the main study. The measurements are going to be performed twice, while hospitalized and 12 weeks after discharge (± 5 days).

Sub-study: 'Prevalence of sarcopenia and investigation of the relationship between nutritional status and the EWGSOP conceptual stages for sarcopenia in hospitalized older patients > 70 years'.

The prevalence and classification of sarcopenia among Danish hospitalized older patients ≥ 70 years old (n=120) will be evaluated, according to the EWGSOP definition (Hand-grip-strength, 4-m gait speed, Bio-Impedance analysis). Also, examination of the relationship between measurements of nutritional status and the EWGSOP stages for sarcopenia (i.e. no sarcopenia, pre-sarcopenia, sarcopenia and severe sarcopenia) will be assessed at baseline. Nutritional status will be assessed according to BMI (< 18.5, 18.5-20.5, 20.5-25, > 25), Mini Nutritional Assessment (MNA) (no MN, risk of MN, MN), Malnutrition Universal Screening Tool (MUST) (low risk of MN, medium risk of MN, high risk of MN), and NRS-2002 (no MN, mild MN, moderate MN, severe MN)

Results will be communicated to the general population and published in peer-reviewed journals.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Protein-enriched, Milk-based Supplement to Counteract Sarcopenia in Acutely Ill Geriatric Patients Offered Resistance Exercise Training During and After Hospitalisation - a Double-blinded, Randomized Controlled Trial
Actual Study Start Date : April 15, 2016
Actual Primary Completion Date : December 20, 2017
Actual Study Completion Date : June 20, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Resistance training and protein
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
Daily intake of supplement
Other Name: Protein-enriched, milk-based supplement (whey protein)

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

Dietary Supplement: Vitamin D
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.

Placebo Comparator: Resistance training and placebo
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
Daily intake of supplement
Other Name: Iso-energetic placebo-supplement (no protein)

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

Dietary Supplement: Vitamin D
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.




Primary Outcome Measures :
  1. Change in 30-s chair stand performance [ Time Frame: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge ]
    Number of stand-ups from a chair in 30 seconds (modified version, help from armrests are allowed).


Secondary Outcome Measures :
  1. Total lean body mass [ Time Frame: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge ]
    Lean body mass (kg and percent) evaluated by bio-impedance analysis (portable, dual-frequency, 8-Point Tactile Electrode System).

  2. Appendicular lean body mass [ Time Frame: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge ]
    Appendicular lean body mass (kg and percent) evaluated by bio-impedance analysis (portable, dual-frequency, 8-Point Tactile Electrode System).

  3. Trunk lean body mass [ Time Frame: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge ]
    Trunk lean body mass (kg and percent) evaluated by bio-impedance analysis (portable, dual-frequency, 8-Point Tactile Electrode System).

  4. Change in hand grip strength [ Time Frame: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge ]
    Isometric hand grip strength (kg) (Saehan Medical digital dynamometer, 2012).

  5. Change in 4 m gait speed [ Time Frame: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge ]
    The time used for walking 4 m (m/s and s )

  6. Change in Activities of daily living (ADL) [ Time Frame: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge ]
    Use of Barthel-100

  7. Change in mobility [ Time Frame: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge ]
    Use of De Morton Mobility Index (DEMMI)

  8. Change in cognitive functioning [ Time Frame: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge ]
    Use of Mini Mental State Examination (MMSE)

  9. Use of home care [ Time Frame: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge ]
    Interview: (yes/no)

  10. Residence [ Time Frame: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge ]
    Interview: (own home, nursing home/assisted living facility, 24-hour rehabilitation facility)

  11. Use of gait aid [ Time Frame: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge ]
    Interview: yes/no/cannot walk and registration of specific gait help

  12. Length of hospital stay (LOS) [ Time Frame: Day of discharge (from hospital) ]
    The in-hospital intervention period (date of recruitment until date of discharge) (days)

  13. Readmission to hospital [ Time Frame: From discharge until 12 weeks post discharge, and 6 months post discharge ]
    Frequency (number)

  14. Length of total hospital stay for readmissions [ Time Frame: From discharge until 12 weeks post discharge, and 6 months post discharge ]
    Total length (days).

  15. Mortality [ Time Frame: From discharge until 12 weeks post discharge, and 6 months post discharge ]
    Mortality (yes/no)

  16. Change in health related Quality of life [ Time Frame: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge ]
    Questionnaire: Euroqol EQ-5D-3L

  17. Change in Body weight [ Time Frame: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge ]
    Measured to the nearest 0.1 kg using a calibrated scale

  18. Study population acceptance of product [ Time Frame: 12 weeks post discharge ]
    Self-administered evaluation-questionnaire


Other Outcome Measures:
  1. Lean body mass (sub group n=30) [ Time Frame: Baseline (while admitted to hospital) and 12 weeks post discharge ]
    Lean body mass (total, appendicular, and trunk) evaluated by whole-body dual energy x-ray absorptiometry (DXA)-scanning.

  2. Fat mass (sub group n=30) [ Time Frame: Baseline (while admitted to hospital) and 12 weeks post discharge ]
    Total mass. Evaluated by whole-body dual energy x-ray absorptiometry (DXA)-scanning and bio-impedance analysis (BIA).

  3. Reliability of bio-impedance analyzer in sub-group (n=30) [ Time Frame: Baseline (while admitted to hospital) ]
    Degree of agreement between two subsequent measurements.

  4. Prevalence of sarcopenia [ Time Frame: Baseline (while admitted to hospital) ]
    According to the EWGSOP definition (yes/no).

  5. Classification of sarcopenia [ Time Frame: Baseline (while admitted to hospital) ]
    According to the EWGSOP definition (pre-sarcopenia, sarcopenia, and severe sarcopenia).

  6. Nutritional status - Body mass index (BMI) [ Time Frame: Baseline (while admitted to hospital) ]
    According to BMI (kg/m2) (< 18.5, 18.5-20.5, 20.5-25, > 25)

  7. Nutritional status - Mini Nutritional Assessment (MNA) [ Time Frame: Baseline (while admitted to hospital) ]
    According to Mini Nutritional Assessment (MNA) (no malnutrition, risk of malnutrition, malnutrition).

  8. Nutritional status - Malnutrition Universal Screening Tool (MUST) [ Time Frame: Baseline (while admitted to hospital) ]
    According to Malnutrition Universal Screening Tool (MUST) (low risk of MN, medium risk of MN, high risk of MN)

  9. Nutritional status - Nutritional Risk Screening 2002 (NRS-2002) [ Time Frame: Baseline (while admitted to hospital) ]
    According to Nutritional Risk Screening 2002 (NRS-2002) (no MN, mild MN, moderate MN, severe MN).

  10. Energy intake [ Time Frame: 4 days while admitted to hospital, or shorter if discharged ]
    Daily registration schemes with pre-printed hospital foods and drinks (energy, kJ/kg).

  11. Protein intake [ Time Frame: 4 days while admitted to hospital, or shorter if discharged ]
    Daily registration schemes with pre-printed hospital foods and drinks (protein, g/kg).

  12. Energy intake [ Time Frame: From discharge until 12 weeks post discharge ]
    Dietary interviews x 4 (24-h recall interviews) (energy, kJ/kg).

  13. Protein intake [ Time Frame: From discharge until 12 weeks post discharge ]
    Dietary interviews x 4 (24-h recall interviews) (protein, g/kg).

  14. Level of daily activity [ Time Frame: From discharge until 12 weeks post discharge ]
    Activity interviews x 4 (recall interviews for the previous week)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • Not being able to lie still in seven minutes (only an exclusion criteria in the sub-study)
  • Withdrawal criteria: Death during admission (does not apply to subsequent admissions)
  • Withdrawal criteria: Discharge/transfer from the medical department before the intervention has started

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717819


Locations
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Denmark
Copenhagen University Hospital Gentofte
Gentofte, Denmark, 2820
Rigshospitalet-Glostrup
Glostrup, Denmark, 2600
Copenhagen University Hospital Herlev
Herlev, Denmark, 2730
Sponsors and Collaborators
Forskningsenheden
University of Copenhagen
The Danish Dairy Research Foundation, Denmark
Arla Foods
Glostrup University Hospital, Copenhagen
University Hospital, Gentofte, Copenhagen
Investigators
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Principal Investigator: Arne Astrup, DMSc Copenhagen University Hospital at Herlev
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Forskningsenheden, Dietetics and Clinical Nutrition Research Unit, Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT02717819    
Other Study ID Numbers: EFFECT.PEPOP.2016
H-16018240 ( Other Identifier: The Danish National Committee on Biomedical Research Ethics )
First Posted: March 24, 2016    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Forskningsenheden, Copenhagen University Hospital at Herlev:
Sarcopenia
Muscular atrophy
Frailty
Acute illness
Ageing
Protein supplementation
Whey protein
Resistance training
Strength training
Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Vitamin D
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents