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

NCT06130956 | Recruiting

• 1 other identifier: 2022023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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

Osteo Arthritis Knee; Protein Synthesis

Outcome Measures

Primary Outcomes (1)

• Change in tissue-specific protein synthesis rates

  Tissue-specific protein synthesis rates in the knee using D2O dosing methodology

  During the 2-week preoperative period

Secondary Outcomes (2)

• Change in blood pressure

  Measured at baseline and 1 day before surgery

• Change in plasma amino acids

  During the 2-week preoperative period

Study Arms (2)

Vegan group

EXPERIMENTAL

Subjects in the vegan group will receive a vegan diet during the 2-week preoperative period.

Dietary Supplement: Vegan diet

Omnivorous group

ACTIVE COMPARATOR

Subjects in the omnivorous group will receive an omnivorous diet during the 2-week preoperative period.

Dietary Supplement: Omnivorous diet

Interventions

Vegan diet DIETARY_SUPPLEMENT

Vegan diet for 2 weeks before surgery

Vegan group

Omnivorous diet DIETARY_SUPPLEMENT

Omnivorous diet for 2 weeks before surgery

Omnivorous group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent;
• Patients scheduled for total knee arthroplasty;
• BMI between 20-32 kg/m2;
• Aged 60 - 80 years;
• Mentally competent, as judged by the treating physician;

You may not qualify if:

• Following a vegetarian or vegan diet or a diet that affects protein intake during the six months prior to the study;
• Participating in a structured progressive exercise training program in the past three months;
• Lost more than 4 kg body weight during three months prior to the study;
• Chronic use of medications that affect protein metabolism (i.e. systemic corticosteroids, or prescription strength acne medications);
• Being diagnosed with one of the following: diabetes mellitus, rheumatoid arthritis, peripheral artery disease Fontaine III or IV, COPD GOLD III or IV, neoadjuvant chemotherapy or radiotherapy, phenylketonuria, collagen disorders (e.g. Marfan and Ehler-Danlos);
• Alcohol abuse;
• Surgical intervention to the knee in the past four weeks;
• Total parenteral nutrition at day of surgery;
• Glomerular filtration rate (GFR) \<20 mL/min/1.73 m2;
• Allergic or intolerant to any product included in the diets;
• Osteoarthritis of the knee secondary to septic arthritis, osteonecrosis, fracture, osteochondritis dissecans, or malignant processes;
• Any other medical condition that may interfere with the safety of the participants or the outcome parameters, in the investigators judgement;
• Not willing to stop nutritional supplements, with the exception of vitamin D and supplements on medical advice.
• Investigator's uncertainty about the willingness or ability of the participant to comply with the protocol instructions;
• Participation in other studies that may have an impact on the outcomes during the three months before the start of the current study.

Sponsors & Collaborators

• Wageningen University: lead
• Gelderse Vallei Hospital: collaborator
• Rijnstate Hospital: collaborator

Study Sites (2)

Rijnstate Hospital

Arnhem, Netherlands

RECRUITING

Hospital Gelderse Vallei

Ede, Netherlands

RECRUITING

MeSH Terms

Interventions

Diet, Vegan

Intervention Hierarchy (Ancestors)

Diet, Vegetarian; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Lisette de Groot, PhD

  Wageningen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Inge Groenendijk, PhD

CONTACT

+31628748271; inge.groenendijk@wur.nl

Lisette de Groot, PhD

CONTACT

lisette.degroot@wur.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof.dr.ir.

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 14, 2023
• Study Start: October 22, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)