A protein supplement has a positive effect on muscle mass, muscle strength and physical functioning during a weight loss trial in overweight elderly.
ID
Bron
Verkorte titel
Aandoening
(Abdominal) obesity, adiposity
(Abdominale) obesitas, adipositas
Ondersteuning
VU Medical Centre
De Boelelaan 1117
room: SG 2 L 47
1081 BT Amsterdam
The Netherlands
Phone: 020-4443211
Fax: 020-4444645
Email: p.weijs@vumc.nl
Danone Research B.V.
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Change in appendicular muscle mass (DXA).
Achtergrond van het onderzoek
To investigate the superiority of a specialised Oral Nutritional Supplement (ONS) vs a control product on muscle mass, body composition, muscle strength, physical functioning and QoL in overweight elderly (55-85y) during a 13 week weight loss period.
Doel van het onderzoek
A protein supplement has a positive effect on muscle mass, muscle strength and physical functioning during a weight loss trial in overweight elderly.
Onderzoeksopzet
1. Baseline;
2. After 7 weeks;
3. After 13 weeks.
Onderzoeksproduct en/of interventie
Duration of intervention: 13 weeks.
1. Intervention group: All participants in the intervention group will receive 10 servings a week of the Active study product, which has a high protein content;
2. Control group: All participants in the control group will receive 10 servings a week of the (isocaloric) Control product.
Both products consist of about 40 grams of powder which has to be dissolved in 125 ml of water and are available in two flavors: vanilla and strawberry.
During the intervention period, subjects consume one serving a day, and on training days one extra (3 days per week).
Both groups will be enrolled in a hypo-caloric weight loss diet and participate in a resistance exercise program comprising 3 supervised group sessions per week at the study centre.
Algemeen / deelnemers
Dr. Meurerlaan 8
A.M. Verreijen
Amsterdam 1067 SM
The Netherlands
+31 (0)20 5953542
a.verreijen@hva.nl
Wetenschappers
Dr. Meurerlaan 8
A.M. Verreijen
Amsterdam 1067 SM
The Netherlands
+31 (0)20 5953542
a.verreijen@hva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Age between 55 and 85 years;
2. BMI > 30 or BMI > 28 + waist circumference > 88 cm (women), > 102 cm (men);
3. Willingness and ability to comply with the study protocol, including:
A. Following dietary advice;
B. Participation in study visits;
C. Taking the study products every day;
D. Ability to comply with the complete study protocol;
E. Ability to understand and fill out questionnaires.
4. The physiotherapist’s view is that the subject is physically fit;
5. Safe to participate in the resistance exercise protocol.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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;
2. Previously known:
A. Kidney failure (previous glomerular filtration rate <30 ml/min);
B. Liver failure;
C. Anaemia (Haemoglobin in men <6.5 mmol/l and women <6.0 mmol/l);
D. (Chronic) inflammatory status.
3. Medication:
A. Corticosteroids for systemic use;
B. Immunosuppressants;
C. Insulin.
4. Dietary or lifestyle characteristics:
A. Participation in a weight loss diet three months before starting and during the study;
B. Use of protein-containing or amino acid-containing nutritional supplements three months before starting and
during the study;
C. Participation in a resistance exercise program three months before starting and during the study;
D. Current alcohol or drug abuse in opinion of the sponsor-investigator.
5. Indications related to interaction with the study product:
A. More than 10 Ig (400 IU) of daily Vitamin D intake from medical sources;
B. More than 500 mg of daily calcium intake from medical sources;
C. Known allergy to milk and milk products;
D. Known galactosaemia.
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL2623 |
NTR-old | NTR2751 |
Ander register | ABR / METc VUMc : 33971 / 2010/280; |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |