Maintenance of muscle mass during weight loss with hypocaloric diet and training in elderly with a protein supplement.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
muscle mass
Secondary outcome
body composition (fat mass and fat free mass)
muscle strength
physical performance
quality of life
Background summary
Obesity is health problem, also for elderly. The current CBO guideline
treatment obesity in the Netherlands does not differentiate between adults and
elderly. However, weight loss in elderly increases risk of muscle loss. This
loss should be minimized or not exist at all. With adults this can be achieved
with hypocaloric diet and resistance exercise. From the literature it appears
that protein requirement of elderly is higher and that a minimal dose of
protein per meal is required to effectively optimize muscle recovery. Therefore
this research is aimed at maintenance of muscle mass with or without protein
supplement.
Study objective
Maintenance of muscle mass during weight loss with hypocaloric diet and
training in elderly with a protein supplement.
Study design
RCT, dubbelblind; 80 persons, 40 per arm; 3 months (13 weeks) intervention
(total duration 14-17 weken dependent on 1-4 weeks between screening and start
study);
Intervention
- hypocaloric diet (according to CBO guideline) dietitian
- resistance exercise 3x per week supervised; program of fysiotherapist
- supplement or placebo 10x per week (7x morning, 3x after training)
Study burden and risks
Based on the available data, no specific adverse effects are anticipated in
elderly with the study products. The ingredients of the study products are
common dietary components with no problems anticipated in the target group of
elderly for the proposed mixture and amounts.
To minimize the potential risks of the resistance exercise program a
physiotherapist will carefully assess each subject individually and decide
whether a subject is capable and it is safe to participate in the resistance
exercise program.
Potential benefits are an increase of muscle mass, muscle strength and physical
functioning, which are the objectives of this study.
De Boelelaan 1117
1081 HV Amsterdam
NL
De Boelelaan 1117
1081 HV Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Age between 55 and 85 years
BMI > 30 or BMI > 28 + waist circumference > 88 cm (women), > 102 cm (men)
Exclusion criteria
Any malignant disease during the last five years except for adequately treated prostate
cancer without evidence of metastases, localized bladder cancer, cervical carcinoma in
situ, breast cancer in situ or non-melanoma skin cancer
- Previously known:
- Kidney failure (previous glomerular filtration rate <30 ml/min)
- Liver failure
- Anaemia (Haemoglobin in men <6.5 mmol/l and women <6.0 mmol/l)
- (Chronic) inflammatory status
- Medication:
- Corticosteroids for systemic use
- Immunosuppressants
- Insulin
- Dietary or life style characteristics:
- Participation in a weight loss diet three months before starting and during the study
- Use of protein-containing or amino acid-containing nutritional supplements three months before starting and during the study
- Participation in a resistance exercise program three months before starting and during the study
- Current alcohol or drug abuse in opinion of the sponsor-investigator
- Indications related to interaction with the study product:
- More than 10 µg (400 IU) of daily Vitamin D intake from medical sources
- More than 500 mg of daily calcium intake from medical sources
- Known allergy to milk and milk products
- Known galactosaemia
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 | NL33971.029.10 |