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Calorie Restriction, Protein Supplementation and Metabolic Health (CRPS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by Washington University School of Medicine
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01538836
First received: February 20, 2012
Last updated: December 9, 2014
Last verified: December 2014
  Purpose

The purpose of this study is to determine whether consuming additional protein during calorie restriction induced weight loss has beneficial or harmful effects on multi-organ (liver, muscle, adipose tissue) insulin sensitivity, colonocyte proliferation rates, the gut microbiome, muscle mass and function, and bone mineral density in obese, postmenopausal women.


Condition Intervention
Obesity
Menopause
Osteoporosis
Sarcopenia
Behavioral: Weight loss with normal protein intake
Behavioral: Weight loss with protein supplementation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Calorie Restriction and Metabolic Health

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Change in muscle mass [ Time Frame: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group ] [ Designated as safety issue: No ]
    We will measure appendicular lean mass by using dual-energy X-ray absorptiometry (DXA) and thigh muscle volume by magnetic resonance imaging (MRI)

  • Change in muscle strength [ Time Frame: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group ] [ Designated as safety issue: No ]
    We will evaluate muscle strength by administering maximum one repetition strength and isokinetic strength tests.

  • Changes in bone mineral density and bone mineral content [ Time Frame: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group ] [ Designated as safety issue: No ]
    We will evaluate total bone mass and total body and regional bone mineral density by using dual X-ray energy absorptiometry (DXA).


Secondary Outcome Measures:
  • Change in skeletal muscle insulin sensitivity [ Time Frame: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group ] [ Designated as safety issue: No ]
    We will evaluate insulin sensitivity using the hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotope labeled tracer infusions

  • Change in muscle protein metabolism [ Time Frame: Baseline and at 5% weight loss in the calorie restriction groups and after ~3 months in the weight maintenance group ] [ Designated as safety issue: No ]
    We will assess rates of muscle protein synthesis, breakdown and net protein balance during postabsorptive conditions and when insulin and/or amino acid concentrations are elevated.

  • Change in bacterial populations found in the stool [ Time Frame: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group ] [ Designated as safety issue: No ]
  • Change in cell proliferation (growth) rates in the colon [ Time Frame: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group ] [ Designated as safety issue: No ]
    We will examine colon cell proliferation rates using stable isotope labelled tracer methods in conjunction with sigmoid colon biopsy samples

  • Determine the acute effect of whey protein ingestion on skeletal muscle insulin sensitivity [ Time Frame: Prior to starting the weight loss or maintenance intervention ] [ Designated as safety issue: No ]
    We will evaluate insulin sensitivity using the hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotope labeled tracer infusions

  • Determine the acute effect of whey protein ingestion on muscle protein metabolism [ Time Frame: Prior to starting the weight loss or maintenance intervention ] [ Designated as safety issue: No ]
    We will assess rates of muscle protein synthesis, breakdown and net protein balance using stable isotope labeled tracer methods during postabsorptive conditions and during insulin infusion with or without whey protein ingestion


Estimated Enrollment: 75
Study Start Date: January 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Weight maintenance
Weight maintenance with normal protein intake
Active Comparator: Weight loss with normal protein intake Behavioral: Weight loss with normal protein intake
Goal of 8 to 10% weight loss while consuming the recommended daily allowance of protein (i.e, 0.8 grams of protein per kg body weight per day).
Experimental: Weight loss with protein supplementation Behavioral: Weight loss with protein supplementation
Goal of 8 to 10% weight loss while consuming 150% of the recommended daily allowance of protein (i.e., 1.2 grams of protein per kg body weight per day).

  Eligibility

Ages Eligible for Study:   50 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Obese with body mass index (BMI) between 30 and 50 kg/m2
  • Postmenopausal
  • Sedentary (i.e., less than 1.5 hours of exercise per week)

Exclusion Criteria:

  • Individuals with diabetes and/or uncontrolled hypertension
  • Individuals with hepatitis B and/or C
  • Individuals who smoke
  • Individuals with an allergy to whey protein
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01538836

Contacts
Contact: Janet Winkelmann, CMA 314-286-2080 jwinkelm@dom.wustl.edu
Contact: Emily Lake, BGS 314-747-3758 lakeem@wusm.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Bettina Mittendorfer, PhD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01538836     History of Changes
Other Study ID Numbers: CRPS-201107354, 1R01DK094483-01A1
Study First Received: February 20, 2012
Last Updated: December 9, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on February 27, 2015