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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Osteo Arthritis Knee; Protein Synthesis
• Intervention / Treatment: Dietary supplement: Vegan diet; Dietary supplement: Omnivorous diet

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisette de Groot, PhD; Email: lisette.degroot@wur.nl
• Study Contact Backup: Name: Inge Groenendijk, PhD; Phone Number: +31628748271; Email: inge.groenendijk@wur.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vegan group; Subjects in the vegan group will receive a vegan diet during the 2-week preoperative period.	Dietary supplement: Vegan diet; Vegan diet for 2 weeks before surgery
Active Comparator: Omnivorous group; Subjects in the omnivorous group will receive an omnivorous diet during the 2-week preoperative period.	Dietary supplement: Omnivorous diet; Omnivorous diet for 2 weeks before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood pressure	Blood pressure measurement using an CE-certified ambulatory blood pressure monitor	Measured at baseline and 1 day before surgery
Change in plasma amino acids	Difference in circulating concentrations between the two diets. In addition, it will be investigated if plasma amino acids can be used as a marker for dietary intake.	During the 2-week preoperative period

Collaborators and Investigators

• Sponsor: Wageningen University
• Collaborators: Rijnstate Hospital; Gelderse Vallei Hospital
• Investigators: Principal Investigator: Lisette de Groot, PhD, Wageningen University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: November 8, 2023
• First Posted (Actual): November 14, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 2022023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No