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Spierbehoud studie.

An exploratory study into the effects of nutritional supplementation on skeletal muscle preservation during a weight loss program in elderly.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24688
Enrollment
80
Registered
2011-02-11
Start date
2011-02-16
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

(Abdominal) obesity, adiposity (Abdominale) obesitas, adipositas

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 dissolve

Sponsors

dr.ir. Peter J.M. Weijs 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
Lead Sponsor

Eligibility

Inclusion criteria

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

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. 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.

Design outcomes

Primary

MeasureTime frame
Change in appendicular muscle mass (DXA).

Secondary

MeasureTime frame
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).

Contacts

Public ContactA.M. Verreijen

Hogeschool van Amsterdam Dr. Meurerlaan 8

a.verreijen@hva.nl+31 (0)20 5953542

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)