Calorie Restriction, Protein Supplementation and Metabolic Health (CRPS)

March 22, 2017 updated by: Washington University School of Medicine

Calorie Restriction and Metabolic Health

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

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: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
No Intervention: Weight maintenance
Weight maintenance with normal protein intake
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in muscle volume
Time Frame: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
Thigh muscle volume will be measured by magnetic resonance imaging (MRI)
Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
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
Muscle strength will be evaluated by administering maximum one repetition strength and isokinetic strength tests.
Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
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
Total bone mass and total body and regional bone mineral density will be evaluated by using dual X-ray energy absorptiometry (DXA).
Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
Change in insulin sensitivity
Time Frame: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
Insulin sensitivity (glucose rate of disappearance [Rd] during a hyperinsulinemic-euglycemic clamp procedure) will be evaluated in a subset of 10 participants per group because power analysis has determined that this number is sufficient to detect a 25% difference between groups assuming 80% power, an alpha value of 0.05 and an average baseline insulin-stimulated glucose Rd of 2,590 ± 492 µmol/min, the average ± SD insulin stimulated glucose Rd the investigators have measured during the past 20 y in obese subjects. In the investigators' experience (Kirk et al., 2009 and Magkos et al., 2016), the weight loss induced increase in insulin stimulated glucose Rd is ~50%.
Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
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
Rates of muscle protein synthesis, breakdown and net protein balance will be assessed during postabsorptive conditions and when insulin and/or amino acid concentrations are elevated.
Baseline and at 5% weight loss in the calorie restriction groups and after ~3 months in the weight maintenance group
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
Colon cell proliferation rates will be determined using stable isotope labelled tracer methods in conjunction with sigmoid colon biopsy samples
Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
Determine the acute effect of whey protein ingestion on skeletal muscle insulin sensitivity
Time Frame: Prior to starting the weight loss or maintenance intervention
Insulin sensitivity will be evaluated using the hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotope labeled tracer infusions
Prior to starting the weight loss or maintenance intervention
Determine the acute effect of whey protein ingestion on muscle protein metabolism
Time Frame: Prior to starting the weight loss or maintenance intervention
Rates of muscle protein synthesis, breakdown and net protein balance will be assessed using stable isotope labeled tracer methods during postabsorptive conditions and during insulin infusion with or without whey protein ingestion
Prior to starting the weight loss or maintenance intervention

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CRPS-201107354
  • 1R01DK094483-01A1 (U.S. NIH Grant/Contract)

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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