Hip ArthritisNCT04496856
Effects of Whey and Collagen on FFM, Muscle Strength and Wound Healing in Elderly Surgical Patients
A study testing Whey protein and Collagen supplementation in people with Hip Arthritis and Sarcopenia, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The purpose of the study is to compare the effect of whey protein and collagen on fat free mass, muscle strength, functional ability, wound healing and life quality in elderly patients undergoing elective knee- or hip surgery (defined as elective knee- or hip arthroplasty). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Arthritis, Sarcopenia, Knee Arthritis
- What is being tested?
- Whey protein and Collagen supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- 10 May 2020to 30 Dec 2020
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65+ years
- Scheduled elective knee- or hip surgery
- Must be able to understand and speak danish
- Must be able to chew and swallow food with a regular consistency
- Must be able to consume the assigned protein supplementation
- Must be able to consent participation
Who cannot join
- Vegan
- Demensia
- Critical complications to the surgery which prevents the patient from participating in the rehabilitation program
- Plasma-creatinin above 250 micromol/L
- Palliative patients
- Known intolerance of whey protein and/or collagen
- Patients with a pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Whey Protein and Collagen on Fat Free Mass, Muscle Strength and Wound Healing in Elderly Patients Undergoing Elective Knee- or Hip Surgery
The purpose of the study is to compare the effect of whey protein and collagen on fat free mass, muscle strength, functional ability, wound healing and life quality in elderly patients undergoing elective knee- or hip surgery (defined as elective knee- or hip arthroplasty). The patients are admitted at the department of Orthopaedic Surgery at Herlev Gentofte Hospital.
- Conditions
- Hip Arthritis, Sarcopenia, Knee Arthritis
- Being tested
- Whey protein and Collagen supplementation
- Keywords
- Hip Arthroplasty, Collagen, Whey protein, Knee Arthroplasty
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey protein and Collagen supplementationDietary supplement
Participants of each arm will consume 30 g daily of the assigned protein supplementation for 30 days. The protein supplementation will be given as protein powder which the participants will have to dissolve in cold drinks. During the intervention fat free mass, muscle strength, functional ability, wound healing and life quality of the participants will be monitored.
| Study group | Role | What they receive |
|---|---|---|
| Collagen | Experimental | Participants of this arm are going to consume 30 g of collagen peptides daily for 30 days Receives: Dietary Supplement: Whey protein and Collagen supplementation |
| Whey Protein | Experimental | Participants of this arm are going to consume 30 g of whey protein daily for 30 days Receives: Dietary Supplement: Whey protein and Collagen supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in fat free mass
The outcome will be monitored through BIA and the development of fat free mass in the operated leg will be compared to the development of fat free mass in the non-operated leg.
Measured: Weekly for 30 days
Secondary outcomes (7)
Wound healing
The amount of days until the wound is healed (defined as: the epithelium is covered without crust). This will be monitored trough pictures and assessed on a scale from 1-5 by a masked doctor.
Measured: Weekly for 30 days
Redness and infection
The redness and infection around the wound assessed on a scale from 1-5 by a masked doctor through pictures.
Measured: Weekly for 30 days
Handgrip strength
Handgrip strength measured by a handdynanometer (SAEHAN) in kg and percentage
Measured: Weekly for 30 days
Extension strength of quadriceps femoris
Measured in amounts of repetitions of 0.5 or 1.0 kg.
Measured: Weekly for 30 days
Life quality
Measured trough EuroQol-5D-5L
Measured: Weekly for 30 days
Difference in functional ability (NMS)
Assessed by New mobility score
Measured: Weekly 30 days
Difference in Chair stand test
Measured by amount of repetitions
Measured: Weekly for 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start10 May 2020
- Primary completion30 Nov 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthritisStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev and Gentofte Hospital
- Responsible party
- Principal investigator, Jens Rikardt Andersen, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04496856
- Sponsor's protocol ID
- ValleKollagen
- Status last verified
- Sep 2021
- First submitted
- 29 Jul 2020
- Last updated
- 29 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Whey Protein and Collagen on Fat Free Mass, Muscle Strength and Wound Healing in Elderly Patients Undergoing Elective Knee- or Hip Surgery
- ClinicalTrials.gov ID
- NCT04496856
- Acronym / sponsor ID
- ValleKollagen
- Conditions
- Hip Arthritis, Sarcopenia, Knee Arthritis
- Keywords
- Hip Arthroplasty, Collagen, Whey protein, Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Herlev and Gentofte Hospital
- Study start
- 10 May 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 3 Aug 2020 (actual)
- 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 compare the effect of whey protein and collagen on fat free mass, muscle strength, functional ability, wound healing and life quality in elderly patients undergoing elective knee- or hip surgery (defined as elective knee- or hip arthroplasty). The patients are admitted at the department of Orthopaedic Surgery at Herlev Gentofte Hospital.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collagen | Experimental | Dietary Supplement: Whey protein and Collagen supplementationParticipants of this arm are going to consume 30 g of collagen peptides daily for 30 days |
| Whey Protein | Experimental | Dietary Supplement: Whey protein and Collagen supplementationParticipants of this arm are going to consume 30 g of whey protein daily for 30 days |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Age 65+ years
- Scheduled elective knee- or hip surgery
- Must be able to understand and speak danish
- Must be able to chew and swallow food with a regular consistency
- Must be able to consume the assigned protein supplementation
Key exclusion criteria (7 listed)
- Vegan
- Demensia
- Critical complications to the surgery which prevents the patient from participating in the rehabilitation program
- Plasma-creatinin above 250 micromol/L
- Palliative patients
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 |
|---|---|---|
| Whey protein and Collagen supplementationParticipants of each arm will consume 30 g daily of the assigned protein supplementation for 30 days. The protein supplementation will be given as protein powder which the participants will have to dissolve in cold drinks. During the intervention fat free mass, muscle strength, functional ability, wound healing and life quality of the participants will be monitored. | Dietary supplement | Collagen, Whey Protein |
Primary outcome
The difference in fat free mass
Time frame: Weekly for 30 days
The outcome will be monitored through BIA and the development of fat free mass in the operated leg will be compared to the development of fat free mass in the non-operated leg.
7 secondary outcomes
Wound healing
Time frame: Weekly for 30 days
Redness and infection
Time frame: Weekly for 30 days
Handgrip strength
Time frame: Weekly for 30 days
Extension strength of quadriceps femoris
Time frame: Weekly for 30 days
Life quality
Time frame: Weekly for 30 days
Difference in functional ability (NMS)
Time frame: Weekly 30 days
Difference in Chair stand test
Time frame: Weekly for 30 days
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 29 Sep 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Hip Arthritis
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Recruiting
Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey protein and Collagen supplementation in people with Hip Arthritis and Sarcopenia, run by University of Copenhagen at 1 site 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 6 inclusion and 7 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 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
The difference in fat free mass (time frame: Weekly for 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2021.