Osteo Arthritis KneeKneeT-veganNCT06130956
The Effect of a 2-week Preoperative Vegan Diet Versus Omnivorous Diet on the Protein Turnover in the Osteoarthritic Knee
A study testing Vegan diet and Omnivorous diet in people with Osteo Arthritis Knee and Protein Synthesis, run by Wageningen University at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Osteo Arthritis Knee, Protein Synthesis
- What is being tested?
- Vegan diet and Omnivorous diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesNetherlands
- Study dates
- 22 Oct 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
Show all 15Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Lisette de Groot, PhD contact
Netherlands2 sites, 2 recruiting
- Recruiting
Rijnstate Hospital
Arnhem
Inge Groenendijk, 0628748271, inge.groenendijk@wur.nl
- Recruiting
Hospital Gelderse Vallei
Ede
Inge Groenendijk, 0628748271, inge.groenendijk@wur.nl
About this study
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.
Read more
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
- Being tested
- Vegan diet, Omnivorous diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vegan dietDietary supplement
Vegan diet for 2 weeks before surgery
Omnivorous dietDietary supplement
Omnivorous diet for 2 weeks before surgery
| Study group | Role | What they receive |
|---|---|---|
| Vegan group | Experimental | Subjects in the vegan group will receive a vegan diet during the 2-week preoperative period. Receives: Dietary Supplement: Vegan diet |
| Omnivorous group | Active comparator | Subjects in the omnivorous group will receive an omnivorous diet during the 2-week preoperative period. Receives: Dietary Supplement: Omnivorous diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tissue-specific protein synthesis rates
Tissue-specific protein synthesis rates in the knee using D2O dosing methodology
Measured: During the 2-week preoperative period
Secondary outcomes (2)
Change in blood pressure
Blood pressure measurement using an CE-certified ambulatory blood pressure monitor
Measured: 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.
Measured: During the 2-week preoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start22 Oct 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Gelderse Vallei Hospital, Rijnstate Hospital
- Responsible party
- Principal investigator, Lisette de Groot, Wageningen University
- Investigators
- Lisette de Groot, PhD, Principal investigator, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06130956
- Sponsor's protocol ID
- 2022023
- Acronym
- KneeT-vegan
- Status last verified
- Mar 2025
- First submitted
- 8 Nov 2023
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a 2-week Preoperative Vegan Diet Versus Omnivorous Diet on the Protein Turnover in the Osteoarthritic Knee
- ClinicalTrials.gov ID
- NCT06130956
- Acronym / sponsor ID
- KneeT-vegan / 2022023
- Conditions
- Osteo Arthritis Knee, Protein Synthesis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Gelderse Vallei Hospital, Rijnstate Hospital
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vegan group | Experimental | Dietary Supplement: Vegan dietSubjects in the vegan group will receive a vegan diet during the 2-week preoperative period. |
| Omnivorous group | Active comparator | Dietary Supplement: Omnivorous dietSubjects in the omnivorous group will receive an omnivorous diet during the 2-week preoperative period. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (15 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vegan dietVegan diet for 2 weeks before surgery | Dietary supplement | Vegan group |
| Omnivorous dietOmnivorous diet for 2 weeks before surgery | Dietary supplement | Omnivorous group |
Primary outcome
Change in tissue-specific protein synthesis rates
Time frame: During the 2-week preoperative period
Tissue-specific protein synthesis rates in the knee using D2O dosing methodology
2 secondary outcomes
Change in blood pressure
Time frame: Measured at baseline and 1 day before surgery
Change in plasma amino acids
Time frame: During the 2-week preoperative period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Osteo Arthritis Knee
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Not yet recruiting
Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
Osteo Arthritis Knee and Hip
Active, not recruiting
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Osteo Arthritis Knee, Joint Diseases
Not yet recruitingPhase 3
A Study to Evaluate Efficacy and Safety of a Single Intra-Articular Injection of HL-01 in the Treatment of Pain in Symptomatic Knee Osteoarthritis
Osteo Arthritis of the Knee
Recruiting
Total Versus Robotic Assisted Unicompartmental Knee Replacement
Osteo Arthritis Knee, Arthritis Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisette de Groot, PhD contact
Lisette de Groot, PhD principal investigator
Wageningen University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vegan diet and Omnivorous diet in people with Osteo Arthritis Knee and Protein Synthesis, run by Wageningen University at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Inge Groenendijk, PhD (+31628748271, inge.groenendijk@wur.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in tissue-specific protein synthesis rates (time frame: During the 2-week preoperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.