SarcopeniaPEPOPNCT02717819
The Importance of Additional Protein to Benefit More From Training During and After Hospitalization
A study testing Protein, Resistance training and Vitamin D in people with Sarcopenia, run by Forskningsenheden at 3 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Protein, Resistance training and Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 3 sitesDenmark
- Study dates
- 15 Apr 2016to 20 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Copenhagen University Hospital Gentofte
Gentofte Municipality, 2820
Rigshospitalet-Glostrup
Glostrup Municipality, 2600
Copenhagen University Hospital Herlev
Herlev, 2730
About this study
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
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).
Read the 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.
- Conditions
- Sarcopenia
- Being tested
- Protein, Placebo, Resistance training, Vitamin D
- Keywords
- Sarcopenia, Muscular atrophy, Frailty, Acute illness, Ageing, Protein supplementation, Whey protein, Resistance training, Strength training
- Medical subject headings
- Sarcopenia, Muscular Atrophy, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProteinDietary supplement
Also called Protein-enriched, milk-based supplement (whey protein)
Daily intake of supplement
PlaceboDietary supplement
Also called Iso-energetic placebo-supplement (no protein)
Daily intake of supplement
Resistance trainingOther
Resistance training (offered daily while hospitalized, and encouragement of 4 x/week as self-training after discharge)
Vitamin DDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo; Other: Resistance training; Dietary Supplement: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 30-s chair stand performance
Number of stand-ups from a chair in 30 seconds (modified version, help from armrests are allowed).
Measured: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Secondary outcomes (18)
Total lean body mass
Lean body mass (kg and percent) evaluated by bio-impedance analysis (portable, dual-frequency, 8-Point Tactile Electrode System).
Measured: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Appendicular lean body mass
Appendicular lean body mass (kg and percent) evaluated by bio-impedance analysis (portable, dual-frequency, 8-Point Tactile Electrode System).
Measured: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Trunk lean body mass
Trunk lean body mass (kg and percent) evaluated by bio-impedance analysis (portable, dual-frequency, 8-Point Tactile Electrode System).
Measured: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Change in hand grip strength
Isometric hand grip strength (kg) (Saehan Medical digital dynamometer, 2012).
Measured: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Change in 4 m gait speed
The time used for walking 4 m (m/s and s )
Measured: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Change in Activities of daily living (ADL)
Use of Barthel-100
Measured: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Change in mobility
Use of De Morton Mobility Index (DEMMI)
Measured: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Change in cognitive functioning
Use of Mini Mental State Examination (MMSE)
Measured: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Use of home care
Interview: (yes/no)
Measured: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Residence
Interview: (own home, nursing home/assisted living facility, 24-hour rehabilitation facility)
Measured: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Use of gait aid
Interview: yes/no/cannot walk and registration of specific gait help
Measured: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Length of hospital stay (LOS)
The in-hospital intervention period (date of recruitment until date of discharge) (days)
Measured: Day of discharge (from hospital)
Readmission to hospital
Frequency (number)
Measured: From discharge until 12 weeks post discharge, and 6 months post discharge
Length of total hospital stay for readmissions
Total length (days).
Measured: From discharge until 12 weeks post discharge, and 6 months post discharge
Mortality
Mortality (yes/no)
Measured: From discharge until 12 weeks post discharge, and 6 months post discharge
Change in health related Quality of life
Questionnaire: Euroqol EQ-5D-3L
Measured: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Change in Body weight
Measured to the nearest 0.1 kg using a calibrated scale
Measured: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Study population acceptance of product
Self-administered evaluation-questionnaire
Measured: 12 weeks post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study start15 Apr 2016
- Primary completion20 Dec 2017
- Study completion20 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forskningsenheden
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, The Danish Dairy Research Foundation, Denmark, Arla Foods, Glostrup University Hospital, Copenhagen, University Hospital, Gentofte, Copenhagen
- Responsible party
- Sponsor-investigator, Forskningsenheden, Copenhagen University Hospital at Herlev
- Investigators
- Arne Astrup, DMSc, Principal investigator, Copenhagen University Hospital at Herlev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02717819
- Sponsor's protocol ID
- EFFECT.PEPOP.2016
- Other IDs
- H-16018240
- Acronym
- PEPOP
- Status last verified
- Aug 2018
- First submitted
- 9 Mar 2016
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31337448Gade 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.
PubMed 29391380
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02717819
- Acronym / sponsor ID
- PEPOP / EFFECT.PEPOP.2016
- Conditions
- Sarcopenia
- Keywords
- Sarcopenia, Muscular atrophy, Frailty, Acute illness, Ageing, Protein supplementation, Whey protein, Resistance training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- ForskningsenhedenUniversity, hospital or other
- Collaborators
- University of Copenhagen, The Danish Dairy Research Foundation, Denmark, Arla Foods, Glostrup University Hospital, Copenhagen, University Hospital, Gentofte, Copenhagen
- Study start
- 15 Apr 2016 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 20 Jun 2018 (actual)
- First posted
- 24 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance training and protein | Experimental | Dietary Supplement: Protein, Other: Resistance training, Dietary Supplement: Vitamin DDaily 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. |
| Resistance training and placebo | Placebo comparator | Dietary Supplement: Placebo, Other: Resistance training, Dietary Supplement: Vitamin DDaily 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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProteinAlso: Protein-enriched, milk-based supplement (whey protein)Daily intake of supplement | Dietary supplement | Resistance training and protein |
| PlaceboAlso: Iso-energetic placebo-supplement (no protein)Daily intake of supplement | Dietary supplement | Resistance training and placebo |
| Resistance trainingResistance training (offered daily while hospitalized, and encouragement of 4 x/week as self-training after discharge) | Other | Resistance training and placebo, Resistance training and protein |
| Vitamin DAiming 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. | Dietary supplement | Resistance training and placebo, Resistance training and protein |
Primary outcome
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).
18 secondary outcomes
Total lean body mass
Time frame: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Appendicular lean body mass
Time frame: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Trunk lean body mass
Time frame: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Change in hand grip strength
Time frame: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Change in 4 m gait speed
Time frame: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Change in Activities of daily living (ADL)
Time frame: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Change in mobility
Time frame: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Change in cognitive functioning
Time frame: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Use of home care
Time frame: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Residence
Time frame: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Use of gait aid
Time frame: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Length of hospital stay (LOS)
Time frame: Day of discharge (from hospital)
Readmission to hospital
Time frame: From discharge until 12 weeks post discharge, and 6 months post discharge
Length of total hospital stay for readmissions
Time frame: From discharge until 12 weeks post discharge, and 6 months post discharge
Mortality
Time frame: From discharge until 12 weeks post discharge, and 6 months post discharge
Change in health related Quality of life
Time frame: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Change in Body weight
Time frame: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge
Study population acceptance of product
Time frame: 12 weeks post discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
- Derived from this study: PubMed 31337448Gade 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.
- Derived from this study: PubMed 29391380Gade 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arne Astrup, DMSc principal investigator
Copenhagen University Hospital at Herlev
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein, Resistance training and Vitamin D in people with Sarcopenia, run by Forskningsenheden at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 30-s chair stand performance (time frame: Baseline (admission to hospital), within 3 days of discharge, and 12 weeks after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02717819, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2018.