Ecologically sustainable nutriton for older adults (55+) with obesity.
- Conditions
- Sarcopene obesitasSarcopenic obesityLoss of muscle mass in severely overweight10003018
- Registration Number
- NL-OMON53195
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 272
Aged 55 or older
Are obese: have a BMI of >30 kg/m2 or BMI >27 kg/m2 and waist circumference >88
cm (women) or >102 cm (men)
Living independently (not in a health facility)
The willingness that the general practitioner will be notified of study
participation
Written informed consent
Willingness to comply with the protocol
Consent of the study physician
Inability to understand the Dutch language
Cognitive impairment (MMSE <15)
Use of total or partial parenteral nutrition (TPN)
Alcohol or drug abuse in the opinion of the investigator
Current enrolment in a fixed rehabilitation program or other intervention
studies
Palliative treatment or a life expectancy of <= 3 months
Following a vegan (100% plant-based) diet
Active medical treatment interfering with this intervention (e.g. cancer
patients receiving systemic and immune therapy)
Physical disabled: unable to meet the general daily exercise guideline for
adults (24)
Planned a holiday during the intervention period and is unable to attend group-
or individual sessions for > 1 week (in phase 1) or > 3 weeks (in phase 2)
The health conditions below will be assessed by the study physician. When a
condition interferes the dietary treatment or if the diet worsens the
participants health it counts as exclusion criteria:
Diagnosed with unstable coronary heart disease (CHD), decompensated heart
failure, uncontrolled hypertension or uncontrolled arrhythmias (e.g. heart
failure NYHA >3)
Diagnosed degenerative neurocognitive disorders
Diagnosed with renal failure
COPD GOLD >3
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is the change in appendicular skeletal muscle mass<br /><br>between baseline and 6-month intervention. The muscle mass is measured with a<br /><br>dual-energy X-ray absorptiometry in kg and percentage of total body weight. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Body composition: fat free mass, total body water, body weight, waist<br /><br>circumference, calf circumference, BMI, muscle quantity<br /><br>Muscle strenth: hand grip strength, lower limb muscle strength<br /><br>Physical performance: daily physical activity, 400m walk test, short physical<br /><br>performance battery, 30 second chair and stand test<br /><br>Metabolic outcomes: blood pressure, heart rate, lipid profile, blood glucose<br /><br>(HOMA-index), inflammation (CRP), nutritional status (vitamin B12 and<br /><br>heamoglobin)<br /><br>Quality of live<br /><br>Vitality<br /><br>Nutritional adequacy</p><br>