NCT04496856

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 3, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

7 months

First QC Date

July 29, 2020

Last Update Submit

September 28, 2021

Conditions

Hip ArthritisSarcopeniaKnee Arthritis

Keywords

Hip ArthroplastyCollagenWhey proteinKnee Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • 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.

    Weekly for 30 days

Secondary Outcomes (7)

  • Wound healing

    Weekly for 30 days

  • Redness and infection

    Weekly for 30 days

  • Handgrip strength

    Weekly for 30 days

  • Extension strength of quadriceps femoris

    Weekly for 30 days

  • Life quality

    Weekly for 30 days

  • +2 more secondary outcomes

Other Outcomes (4)

  • Palatability of the protein supplementation

    30 days

  • Consistency of the protein supplementation

    30 days

  • Compliance of the protein supplementation intake

    Weekly for 30 days

  • +1 more other outcomes

Study Arms (2)

Collagen

EXPERIMENTAL

Participants of this arm are going to consume 30 g of collagen peptides daily for 30 days

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

Dietary Supplement: Whey protein and Collagen supplementation

Interventions

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.

CollagenWhey Protein

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev/Gentofte Hospital

Gentofte Municipality, Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Whey Proteins

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 29, 2020

First Posted

August 3, 2020

Study Start

May 10, 2020

Primary Completion

November 30, 2020

Study Completion

December 30, 2020

Last Updated

September 29, 2021

Record last verified: 2021-09

Locations

DK(1)