Primary: 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, bone, ligaments, menisci, and cartilage in older adults with knee osteoarthritis…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters are protein synthesis rates of Hoffa*s fat pad,
synovium, bone, ligament, menisci, and cartilage.
Secondary outcome
Secondary parameters include blood pressure, and plasma amino acids.
Background summary
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.
Study objective
Primary: 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, bone, ligaments, menisci, and cartilage in older adults with knee
osteoarthritis undergoing total knee arthroplasty.
Secondary: 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.
Intervention
Controlled vegan diet versus controlled omnivorous diet, both for a duration of
14 days.
Study burden and risks
The risks of the study are minimal and acceptable. All products in the diets
are commercially available. The short duration of the vegan diet excludes the
possible risks of fractures, muscle wasting and vitamin B12 deficiency. Methods
used to explore the effects have been widely used in other studies and will be
performed according to standard operating procedures. No serious side effects
have been previously observed following the deuterated water protocol that will
be used in this study. Venipuncture will be performed by trained professionals
and may cause some discomfort, but further risks are minor. Tissue collection
will be performed during the surgical procedure. Since a plant-based diet is
increasingly promoted, scientific evidence is necessary to assess the effects
of such a diet on health outcomes.
Stippeneng 4
Wageningen 6708WE
NL
Stippeneng 4
Wageningen 6708WE
NL
Listed location countries
Age
Inclusion criteria
- Written informed consent;
- Male and female 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,
phenylketonuria, collagen disorders (e.g. Marfan and Ehler-Danlos);
- Receiving neoadjuvant chemotherapy or radiotherapy;
- Alcohol abuse (for men 15 or more alcoholic drinks per week and for women 8
or more alcoholic drinks per week);
- 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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL85073.091.23 |
| Other | Volgt |