Protect, The impact of a high protein diet on the preservation of muscle mass during caloric restriction in overweight middle-aged to elderly people

Completed

Conditions: obesitas
loss of muscle mass during weight reduction
10018424
10028302

Registration Number: NL-OMON37859

Lead Sponsor: TI Food and Nutrition

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

- Overweight or obese (BMI 27-35 kg/m2)
- Waist circumference male: >=102 cm, female: >=88cm
- Age in between 55-70 years
- Willingness and ability to comply with the protocol

Exclusion Criteria

- Renal insufficiency (MDRD eGFR > 60ml/min/1.73 m2)
- Type 1 or type II diabetes (fasting glucose level >=7 mmol/l)
- Cancer
- COPD
- Participation in weight loss program 3 months before the intervention
- Participation of any heavy resistance-type exercise training (>1 wk) the last 2 years
- Intentional or unintentional weight loss (>3 kg in the last 3 months)
- Severe loss appetite
- Diagnosed allergy to milk products
- Gastric bypass
- Supplements or medication use for weight loss
- Participation in any other intervention trial
- For women: last period >= 1 year ago

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Difference in Skeletal muscle mass after 12 weeks</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures:<br /><br>• BMI<br /><br>• Body weight<br /><br>• Total fat mass (DXA)<br /><br>• Bone mineral density (DXA)<br /><br>• Leg strength (1RM leg press/extension)<br /><br>• Handgrip strength<br /><br>• Physical performance (SPPB, 400 m walk test)<br /><br>• Activities of daily living<br /><br>• Muscle fiber/type size, satellite cells (biopsy)<br /><br>• Fasting glucose level<br /><br>• 2-h plasma glucose level (assessed by OGTT)<br /><br>• HbA1c<br /><br>• Insulin<br /><br>• Lipid profile<br /><br>• Habitual physical activity (Accelerometer)<br /><br>• Microbial composition and metabolite profiles.<br /><br>- Gene expression in adiopose tissue</p><br>