The primary objective is to study the protein intake in a three-month high-protein vegetarian diet vs a high-protein omnivorous diet, both in combination with a resistance exercise training program in healthy older adults. To investigate the effects…
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Source
Brief title
Condition
- Other condition
Synonym
Health condition
geen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is the protein intake after the twelve-week
intervention. The protein intake will be measured with 3-day dietary record.
Secondary outcome
The secondary study parameter is the change in appendicular skeletal muscle
mass (ASMM) between baseline and after the three-month intervention. The
muscle mass is measured with a dual-energy X-ray absorptiometry (DXA) in kg and
percentage of total body weight. This study will assess the following
parameters explorative: muscle strength and physical performance, body
composition, cardiovascular parameters, nutritional status, and environmental
outcomes.
Background summary
Sarcopenia, the age-related decline of muscle mass, strength, and function is
associated with the increased chance of physical disability, falls, fractures,
mortality, and a lower quality of life. High-protein intake in combination with
physical activity are important strategies to reduce this decline. High-protein
diets are often high in animal-based products, due to their sufficient amount
of high-quality protein. However, animal-based products, especially meat, are
also associated with a larger environmental footprint. Consuming high levels of
high-quality proteins to preserve muscle mass is challenging with a (more)
plant-based diet. Transitioning towards a more, but not exclusively plant-based
diet (i.e., a vegetarian diet) could still decrease the environmental footprint
compared to an omnivorous diet and could easier lead to a sufficient
high-quality protein intake.
Study objective
The primary objective is to study the protein intake in a three-month
high-protein vegetarian diet vs a high-protein omnivorous diet, both in
combination with a resistance exercise training program in healthy older
adults. To investigate the effects on appendicular skeletal muscle mass (ASMM)
is the secondary objective. Muscle strength, physical performance, body
composition, cardiovascular parameters, nutritional status, and environmental
outcomes will be assessed explorative.
Study design
In a non-blinded randomized controlled trial (RCT), healthy older adults will
follow a three-month high-protein vegetarian diet or high-protein omnivorous
diet both in combination with a resistance exercise training program (three
times per week).
Intervention
The participants will follow a three-month high-protein (>=1.2g/kg/d) vegetarian
diet (>=60% plant-based proteins) or high-protein (>=1.2g/kg/d) omnivorous diet
(>=60% animal-based proteins) both in combination with a resistance exercise
training program (three times per week).
Study burden and risks
The risks associated with participation are minimal. Assessments will be
carried out in a private controlled setting and interventions are guided by
dieticians (in training), physiotherapists (in training), and researchers.
Participation in this study should benefit older adults by improving body
composition, increasing knowledge and skills, and providing social aspects and
personal health insights. The results of this trial will be used to support
evidence-based practice for more environmentally sustainable diets to preserve
or increase muscle mass.
dr meurerlaan 8
Amsterdam 1067SM
NL
dr meurerlaan 8
Amsterdam 1067SM
NL
Listed location countries
Age
Inclusion criteria
• Aged 55 years or older
• BMI 18.5-30 kg/m2
• Living independently
• Ability and willingness to comply with the protocol
• Written an informed consent
• Consent of the study physician
Exclusion criteria
• Alcohol abuse (>14 glasses per week (women) or >21 glasses per week (men)) or
drug abuse in the opinion of the study physician
• Inability to understand the Dutch language
• Cognitive impairment (MMSE < 25)
• Diagnosed chronic disease that may interfere with protocol (e.g.,
cardiovascular, gastrointestinal, neurological, renal diseases, and/or diabetes)
• Bariatric surgery
• Current enrolment in an exercise program or other intervention study
• Planned a holiday during the intervention period and is unable to attend
training sessions for > 1 week
Design
Recruitment
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 |
|---|---|
| ClinicalTrials.gov | NCT06172725 |
| CCMO | NL84531.018.23 |