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

Completed

• Conditions: obesitas; Adiposity; overweight

• Registration Number: NL-OMON34540
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 80

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>muscle mass</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>body composition (fat mass and fat free mass)<br /><br>muscle strength<br /><br>physical performance<br /><br>quality of life</p><br>