NCT01915030CompletedNot Applicable
Protect The Impact of a High Protein Diet on the Preservation of Muscle Mass During Caloric Restriction in Middle Age and Elderly People
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Wageningen University
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- Change in Body composition
Study Overview
Brief Summary
The present study is designed to investigate whether a high protein diet will preserve muscle mass during caloric restriction in older adults.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 55 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
- •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)
Arms & Interventions
High protein diet
Experimental
High protein diet during caloric restriction
Intervention: High protein diet (Other)
Standard protein diet
Placebo Comparator
Standard protein diet during caloric restriction
Intervention: standard protein diet (Other)
Outcomes
Primary Outcomes
Change in Body composition
Time Frame: baseline and 12 weeks
DEXA scan
Secondary Outcomes
- Physical performance(baseline and 12 weeks)
- Blood related parameters(baseline and 12 weeks)
- Muscle related parameters(baseline and 12 weeks)
- Physical activity(baseline and 12 weeks)
Investigators
Study Sites (1)
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