Effects of Whey and Collagen on FFM, Muscle Strength and Wound Healing in Elderly Surgical Patients

• Sponsor: University of Copenhagen (Other)
• Overall Status: Completed
• CT.gov ID: NCT04496856
• Collaborator: Herlev and Gentofte Hospital (Other)
• Enrollment: 15
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.7
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief 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). The patients are admitted at the department of Orthopaedic Surgery at Herlev Gentofte Hospital.

Condition or Disease	Intervention/Treatment	Phase
Hip Arthritis; Sarcopenia; Knee Arthritis	Dietary Supplement: Whey protein and Collagen supplementation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• 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
• Actual Study Start Date: May 10, 2020
• Actual Primary Completion Date: Nov 30, 2020
• Actual Study Completion Date: Dec 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Collagen Participants of this arm are going to consume 30 g of collagen peptides daily for 30 days	Dietary Supplement: Whey protein and Collagen supplementation; 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.
Experimental: Whey Protein Participants of this arm are going to consume 30 g of whey protein daily for 30 days	Dietary Supplement: Whey protein and Collagen supplementation; 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.

Outcome Measures

Primary Outcome Measures

1. The difference in fat free mass [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.

Secondary Outcome Measures

1. Wound healing [Weekly for 30 days]

   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.

2. Redness and infection [Weekly for 30 days]

   The redness and infection around the wound assessed on a scale from 1-5 by a masked doctor through pictures.

3. Handgrip strength [Weekly for 30 days]

   Handgrip strength measured by a handdynanometer (SAEHAN) in kg and percentage

4. Extension strength of quadriceps femoris [Weekly for 30 days]

   Measured in amounts of repetitions of 0.5 or 1.0 kg.

5. Life quality [Weekly for 30 days]

   Measured trough EuroQol-5D-5L

6. Difference in functional ability (NMS) [Weekly 30 days]

   Assessed by New mobility score

7. Difference in Chair stand test [Weekly for 30 days]

   Measured by amount of repetitions

Other Outcome Measures

1. Palatability of the protein supplementation [30 days]

   Assessed on a scale from 1-5

2. Consistency of the protein supplementation [30 days]

   Assessed on a scale from 1-5

3. Compliance of the protein supplementation intake [Weekly for 30 days]

   Assessed trough a weekly form, which the participants will fill in

4. Rapported side effects [30 days]

   Participants will be informed to rapport if they experience any side effects throughout the intervention

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Herlev/Gentofte Hospital	Gentofte	Hellerup	Denmark	2900

Sponsors and Collaborators

• University of Copenhagen
• Herlev and Gentofte Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jens Rikardt Andersen, Associate Professor, University of Copenhagen
• ClinicalTrials.gov Identifier: NCT04496856
• Other Study ID Numbers: ValleKollagen
• First Posted: Aug 3, 2020
• Last Update Posted: Sep 29, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jens Rikardt Andersen, Associate Professor, University of Copenhagen: Hip Arthroplasty; Collagen; Whey protein; Knee Arthroplasty
• Additional relevant MeSH terms: Arthritis; Sarcopenia

Study Results

No Results Posted as of Sep 29, 2021