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

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

Official Title
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Protect The Impact of a High Protein Diet on the Preservation of Muscle Mass During Caloric Restriction in Middle Age and Elderly People

Conditions
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Obesity

Intervention / Treatment
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* Other: High protein diet
* Other: standard protein diet


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High protein diet<br>High protein diet during caloric restriction | Other: High protein diet<br>* controlled feeding trail. Both arms are caloric restricted<br>|
| Placebo Comparator: Standard protein diet<br>Standard protein diet during caloric restriction | Other: standard protein diet<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body composition | DEXA scan | baseline and 12 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Muscle, Physical performance, Protein, Diet, Caloric restriction