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

July 30, 2013 updated by: Wageningen University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Wageningen, Gelderland, Netherlands, 6703HD
        • Wageningen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical performance
Time Frame: 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
baseline and 12 weeks
Blood related parameters
Time Frame: baseline and 12 weeks
Glucose, insulin, HbA1c, lipid profile
baseline and 12 weeks
Muscle related parameters
Time Frame: baseline and 12 weeks
muscle biopsies (muscle fiber type)
baseline and 12 weeks
Physical activity
Time Frame: baseline and 12 weeks
Questionnaire LAPAQ - Activities of Daily Living
baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wageningen University

Collaborators

Maastricht University
Top Institute Food and Nutrition

Investigators

  • Principal Investigator: Lisette de Groot, professor, Prof. Wageningen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

July 31, 2012

First Submitted That Met QC Criteria

July 30, 2013

First Posted (Estimate)

August 2, 2013

Study Record Updates

Last Update Posted (Estimate)

August 2, 2013

Last Update Submitted That Met QC Criteria

July 30, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • WM002-wp3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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