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| Name | Class |
|---|---|
| Gelderse Vallei Hospital | OTHER |
| Rijnstate Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vegan group | Experimental | Subjects in the vegan group will receive a vegan diet during the 2-week preoperative period. |
|
| Omnivorous group | Active Comparator | Subjects in the omnivorous group will receive an omnivorous diet during the 2-week preoperative period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vegan diet | Dietary Supplement | Vegan diet for 2 weeks before surgery |
| |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Inge Groenendijk, PhD | Contact | +31628748271 | inge.groenendijk@wur.nl | |
| Lisette de Groot, PhD | Contact | lisette.degroot@wur.nl |
| Name | Affiliation | Role |
|---|---|---|
| Lisette de Groot, PhD | Wageningen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rijnstate Hospital | Recruiting | Arnhem | Netherlands |
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| ID | Term |
|---|---|
| D000067269 | Diet, Vegan |
| ID | Term |
|---|---|
| D014676 | Diet, Vegetarian |
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
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| Omnivorous diet |
| Dietary Supplement |
Omnivorous diet for 2 weeks before surgery |
|
| During the 2-week preoperative period |
| Hospital Gelderse Vallei | Recruiting | Ede | Netherlands |
|
| D013812 |
| Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |