|- candidate number||9106|
|- NTR Number||NTR2751|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-feb-2011|
|- Secondary IDs||33971 / 2010/280; ABR / METc VUMc|
|- Public Title||Spierbehoud studie.|
|- Scientific Title||An exploratory study into the effects of nutritional supplementation on skeletal muscle preservation during a weight loss program in elderly.
|- ACRONYM||Muscle preservation study|
|- hypothesis||A protein supplement has a positive effect on muscle mass, muscle strength and physical functioning during a weight loss trial in overweight elderly.|
|- Healt Condition(s) or Problem(s) studied||Obesity, Adipositas|
|- Inclusion criteria||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.
|- Exclusion criteria||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.
A. Corticosteroids for systemic use;
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.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||16-feb-2011|
|- planned closingdate||16-nov-2011|
|- Target number of participants||80|
|- Interventions||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.
|- Primary outcome||Change in appendicular muscle mass (DXA).|
|- Secondary outcome||1. Body composition (BodPod, BIA);|
2. Muscle strength (hand-grip, leg-extension);
3. physical functioning (chair stand, gait speed, 400m walking test);
4. Quality of Life (RAND-36 questionaire).
|- Timepoints||1. Baseline;|
2. After 7 weeks;
3. After 13 weeks.
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES|| A.M. Verreijen|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Ir. Peter J.M. Weijs|
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|Danone Research B.V. , University of Applied Science, Amsterdam (Hogeschool van Amsterdam)|
|- Publications||Verreijen AM, Verlaan S, Engberink MF, Swinkels S, de Vogel-van den Bosch J, Weijs PJ. A high whey protein-, leucine-, and vitamin D-enriched supplement preserves muscle mass during intentional weight loss in obese older adults: a double-blind randomized controlled trial. Am J Clin Nutr. 2015 Feb;101(2):279-86.|
|- Brief summary||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.|
|- Main changes (audit trail)|
|- RECORD||11-feb-2011 - 3-jan-2017|