The objective of this study is to evaluate the effects of excercise training and/or a high protein hypocaloric diet on improvement of body composition (preservation fat free mass), muscle strength, physical functioning and quality of life in an…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
overgewicht en obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
fat free mass
Secondary outcome
muscle strength
physical functioning
quality of life
Background summary
Overweight and obesity are a health problem, also for the elderly. The current
CBO guideline for the treatment of obesity in the Netherlands does not
differentiate beween adults and elderly. However, weight loss in elderly
increases risk of muscle loss and therefore potentially loss of strength and
physical functioning. This loss should be prevented. From literature it appears
that a high protein diet and resistance training might result in preservation
of fat free mass.
Study objective
The objective of this study is to evaluate the effects of excercise training
and/or a high protein hypocaloric diet on improvement of body composition
(preservation fat free mass), muscle strength, physical functioning and quality
of life in an overweight elderly (55+) population.
Study design
2-by-2 factorial design; 100 subjects; 50 subjects receive a hypocaloric high
protein diet (the other 50 receive a regular hypocaloric diet) and 50 subjects
are enrolled in a resistance training program (the other 50 receive exercise
advise according to the CBO guidelines).
Intervention
- Regular hypocaloric diet and exercise advise according to the CBO guidelines.
- Hypocaloric high protein diet and eercise advise according to the CBO
guidelines.
- Regular hypocaloric diet and resistance training.
- Hypocaloric high protein diet and resistance training.
Study burden and risks
Based on available literature, no specific adverse effect of the high protein
diet (1.3g/kg) are expected. The study physician will judge on eligibility
based on subject's medical history and medication use. To minimize the
potential risk of the resistance exercise program, a physiotherapist will
carefully assess each subject and decide whether a subject is capable and
whether it is safe to participate in the resistance exercise program. Potential
benefits are preservation of fat free mass, muscle strength and physical
functioning, which are the objectives of this study.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
BMI>28 and/or BMI > 25 with a waist circumference > 88 cm (women) or > 102 cm (men)
Age >=55 year
Exclusion criteria
renal failure
cardiovascular disease
Diabetes Mellitus with insulin
exercise asthma
dysfunction of joints
use of antidepressant (< 1 year)
thyroid dysfunction (use of thyroid medication with changed dosage in last 12 months. When stable, subjects can be included.)
Participation in a resistance exercise and/or weight loss program three months before starting and during the study
Current alcohol or drug abuse in opinion of the sponsor-investigator
Known allergy to milk and milk products
Known galactosaemia
Sponsor-investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
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 |
|---|---|
| CCMO | NL43226.072.14 |