Protect - The Impact of a High Protein Diet on Preservation of Muscle Mass
Protect The Impact of a High Protein Diet on the Preservation of Muscle Mass During Caloric Restriction in Middle Age and Elderly People
1 other identifier
interventional
61
1 country
1
Brief Summary
The present study is designed to investigate whether a high protein diet will preserve muscle mass during caloric restriction in older adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Jun 2012
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 31, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFirst Posted
Study publicly available on registry
August 2, 2013
CompletedAugust 2, 2013
July 1, 2013
6 months
July 31, 2012
July 30, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Body composition
DEXA scan
baseline and 12 weeks
Secondary Outcomes (4)
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
Study Arms (2)
High protein diet
EXPERIMENTALHigh protein diet during caloric restriction
Standard protein diet
PLACEBO COMPARATORStandard protein diet during caloric restriction
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wageningen Universitylead
- Maastricht Universitycollaborator
- Top Institute Food and Nutritioncollaborator
Study Sites (1)
Wageningen University
Wageningen, Gelderland, 6703HD, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lisette de Groot, professor
Prof. Wageningen University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2012
First Posted
August 2, 2013
Study Start
June 1, 2012
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
August 2, 2013
Record last verified: 2013-07