Protect - The Impact of a High Protein Diet on Preservation of Muscle Mass

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Other: High protein diet; Other: standard protein diet

• Registration Number: NCT01915030
• Lead Sponsor: Wageningen University

Brief Summary

The present study is designed to investigate whether a high protein diet will preserve muscle mass during caloric restriction in older adults.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-07-31
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-07
• Study First Submitted QC: 2013-07-30
• Last Update Submitted: 2013-07-30
• Study First Posted: 2013-08-02
• Last Update Posted: 2013-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• Overweight and obese subjects (BMI 27-40 kg/m2)
• Waist circumference male:≥ 102 cm, female: ≥ 88 cm
• Willingness and ability to comply with the protocol

Exclusion Criteria

• Renal insufficiency
• Co-morbidities
• Type 1 & 2 diabetics (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 y.
• 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
• Women can only participate if they are postmenopausal (last period ≥ a year ago)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High protein diet	High protein diet	High protein diet during caloric restriction
Standard protein diet	standard protein diet	Standard protein diet during caloric restriction

Primary Outcome Measures

Name	Time	Method
Change in Body composition	baseline and 12 weeks	DEXA scan

Secondary Outcome Measures

Name	Time	Method
Physical activity	baseline and 12 weeks	Questionnaire LAPAQ - Activities of Daily Living
Physical performance	baseline and 12 weeks	1. Short Physical Performance Battery (SPPB), maximum score is 12.; 2. Leg strength by 1 Repetition Maximum, both leg extension and leg press; 3. Handgrip strength; 4. Time to walk 400m
Blood related parameters	baseline and 12 weeks	Glucose, insulin, HbA1c, lipid profile
Muscle related parameters	baseline and 12 weeks	muscle biopsies (muscle fiber type)

Trial Locations

Locations (1)

Wageningen University; 🇳🇱 Wageningen, Gelderland, Netherlands