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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-80
SponsorWageningen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent;

Patients scheduled for total knee arthroplasty;

BMI between 20-32 kg/m2;

Aged 60 - 80 years;

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vegan diet

    Dietary supplement

    Vegan diet for 2 weeks before surgery

  • Omnivorous diet

    Dietary supplement

    Omnivorous diet for 2 weeks before surgery

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Vegan groupExperimental treatment 1 intervention
Group B: Omnivorous groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in tissue-specific protein synthesis rates

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

Time frame
During the 2-week preoperative period

Secondary outcomes

1

Change in blood pressure

Blood pressure measurement using an CE-certified ambulatory blood pressure monitor

Time frame
Measured at baseline and 1 day before surgery
2

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.

Time frame
During the 2-week preoperative period

Other outcomes

Sponsors and contacts

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Wageningen University

Lead sponsor

Gelderse Vallei Hospital

Collaborator

Rijnstate Hospital

Collaborator