Actively Recruiting

Phase Not Applicable
Age: 60Years - 80Years
All Genders
NCT06130956

The Effect of a 2-week Preoperative Vegan Diet Versus Omnivorous Diet on the Protein Turnover in the Osteoarthritic Knee

Led by Wageningen University · Updated on 2025-04-01

40

Participants Needed

2

Research Sites

110 weeks

Total Duration

On this page

Sponsors

W

Wageningen University

Lead Sponsor

G

Gelderse Vallei Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Rationale: Protein from plant-based foods may be unable to stimulate protein synthesis due to a suboptimal essential amino acid content and a lower digestibility. However, a more optimal amino acid profile may be achieved by increasing portions sizes and blending multiple plant-based sources. Studies investigating the anabolic properties of vegan diets (total elimination of animal-based foods) rather than single plant-based foods in older adults are scarce. It remains unknown if a vegan diet can also affect protein synthesis rates in other musculoskeletal tissues than muscle. Primary objective: To assess the effects of a 2-week preoperative vegan diet in comparison to an omnivorous diet on protein synthesis rates in Hoffa's fat pad, synovium, tendon, bone, ligaments, menisci, and cartilage in older adults with knee osteoarthritis undergoing total knee arthroplasty. Secondary objective: To assess the effects of a 2-week preoperative vegan diet in comparison to an omnivorous diet on blood pressure and plasma amino acids in older adults with knee osteoarthritis undergoing total knee arthroplasty. Study design: Multi-center, randomized, controlled trial with an intervention and a control group. Study population: 40 older adults (60 - 80 years) with osteoarthritis of the knee undergoing total knee replacement. Intervention: Controlled vegan diet versus controlled omnivorous diet, for a duration of 14 days. Main study parameters/endpoints: Primary study parameters are protein synthesis rates of Hoffa's fat pad, synovium, tendon, bone, ligament, menisci, and cartilage. Secondary parameters include blood pressure and plasma amino acids.

CONDITIONS

Official Title

The Effect of a 2-week Preoperative Vegan Diet Versus Omnivorous Diet on the Protein Turnover in the Osteoarthritic Knee

Who Can Participate

Age: 60Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent
  • Scheduled for total knee arthroplasty
  • Body mass index between 20 and 32 kg/m2
  • Aged between 60 and 80 years
  • Mentally competent as judged by the treating physician
Not Eligible

You will not qualify if you...

  • Following a vegetarian or vegan diet or a diet affecting protein intake in the last six months
  • Participated in a structured progressive exercise training program in the past three months
  • Lost more than 4 kg body weight in the last three months
  • Chronic use of medications affecting protein metabolism (e.g., systemic corticosteroids, prescription acne medications)
  • Diagnosed with diabetes mellitus, rheumatoid arthritis, peripheral artery disease Fontaine III or IV, COPD GOLD III or IV, neoadjuvant chemotherapy or radiotherapy, phenylketonuria, or collagen disorders (e.g., Marfan, Ehler-Danlos)
  • Alcohol abuse
  • Knee surgery in the past four weeks
  • Receiving total parenteral nutrition at day of surgery
  • Glomerular filtration rate (GFR) below 20 mL/min/1.73 m2
  • Allergy or intolerance to any diet products
  • Knee osteoarthritis caused by septic arthritis, osteonecrosis, fracture, osteochondritis dissecans, or malignant processes
  • Any medical condition interfering with participant safety or study outcomes as judged by investigators
  • Unwilling to stop nutritional supplements except vitamin D and medically advised supplements
  • Investigator doubts about participant compliance
  • Participation in other studies affecting outcomes within three months before this study

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Rijnstate Hospital

Arnhem, Netherlands

Actively Recruiting

2

Hospital Gelderse Vallei

Ede, Netherlands

Actively Recruiting

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Research Team

I

Inge Groenendijk, PhD

CONTACT

L

Lisette de Groot, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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