AzTrials
AzTrials

ObesityCRPSNCT01538836

Calorie Restriction, Protein Supplementation and Metabolic Health

A study testing Weight loss with normal protein intake and Weight loss with protein supplementation in people with Obesity and Menopause, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 50 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Obesity, Menopause, Osteoporosis
What is being tested?
Weight loss with normal protein intake and Weight loss with protein supplementation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteUnited States
Study dates
Jan 2012to Mar 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • Individuals with diabetes and/or uncontrolled hypertension
  • Individuals with hepatitis B and/or C
  • Individuals who smoke
  • Individuals with an allergy to whey protein

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: 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.

Being tested
Weight loss with normal protein intake, Weight loss with protein supplementation
Medical subject headings
Obesity, Osteoporosis, Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Weight loss with normal protein intakeBehavioural

    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).

  • Weight loss with protein supplementationBehavioural

    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).

Study groups in NCT01538836
Study groupRoleWhat they receive
Weight maintenanceNo interventionWeight maintenance with normal protein intake
Weight loss with normal protein intakeActive comparatorNot described
Receives: Behavioral: Weight loss with normal protein intake
Weight loss with protein supplementationExperimentalNot described
Receives: Behavioral: Weight loss with protein supplementation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in muscle volume

    Thigh muscle volume will be measured by magnetic resonance imaging (MRI)

    Measured: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group

  2. Change in muscle strength

    Muscle strength will be evaluated by administering maximum one repetition strength and isokinetic strength tests.

    Measured: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group

  3. Changes in bone mineral density and bone mineral content

    Total bone mass and total body and regional bone mineral density will be evaluated by using dual X-ray energy absorptiometry (DXA).

    Measured: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group

Secondary outcomes (6)

  1. Change in insulin sensitivity

    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%.

    Measured: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group

  2. Change in muscle protein metabolism

    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.

    Measured: Baseline and at 5% weight loss in the calorie restriction groups and after ~3 months in the weight maintenance group

  3. Change in bacterial populations found in the stool

    Measured: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group

  4. Change in cell proliferation (growth) rates in the colon

    Colon cell proliferation rates will be determined using stable isotope labelled tracer methods in conjunction with sigmoid colon biopsy samples

    Measured: Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group

  5. Determine the acute effect of whey protein ingestion on skeletal muscle insulin sensitivity

    Insulin sensitivity will be evaluated using the hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotope labeled tracer infusions

    Measured: Prior to starting the weight loss or maintenance intervention

  6. Determine the acute effect of whey protein ingestion on muscle protein metabolism

    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

    Measured: Prior to starting the weight loss or maintenance intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionMar 2017
  4. Study completionMar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01538836
Sponsor's protocol ID
CRPS-201107354
Other IDs
1R01DK094483-01A1
Acronym
CRPS
Status last verified
Mar 2017
First submitted
20 Feb 2012
Last updated
27 Mar 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Kirk E, Reeds DN, Finck BN, Mayurranjan SM, Patterson BW, Klein S. Dietary fat and carbohydrates differentially alter insulin sensitivity during caloric restriction. Gastroenterology. 2009 May;136(5):1552-60. doi: 10.1053/j.gastro.2009.01.048. Epub 2009 Jan 25.

    PubMed 19208352

  • Magkos F, Bradley D, Eagon JC, Patterson BW, Klein S. Effect of Roux-en-Y gastric bypass and laparoscopic adjustable gastric banding on gastrointestinal metabolism of ingested glucose. Am J Clin Nutr. 2016 Jan;103(1):61-5. doi: 10.3945/ajcn.115.116111. Epub 2015 Nov 25.

    PubMed 26607940

  • Smith GI, Yoshino J, Kelly SC, Reeds DN, Okunade A, Patterson BW, Klein S, Mittendorfer B. High-Protein Intake during Weight Loss Therapy Eliminates the Weight-Loss-Induced Improvement in Insulin Action in Obese Postmenopausal Women. Cell Rep. 2016 Oct 11;17(3):849-861. doi: 10.1016/j.celrep.2016.09.047.

    PubMed 27732859

  • Smith GI, Patterson BW, Klein SJ, Mittendorfer B. Effect of hyperinsulinaemia-hyperaminoacidaemia on leg muscle protein synthesis and breakdown: reassessment of the two-pool arterio-venous balance model. J Physiol. 2015 Sep 15;593(18):4245-57. doi: 10.1113/JP270774. Epub 2015 Aug 14.

    PubMed 26150260

  • Smith GI, Yoshino J, Stromsdorfer KL, Klein SJ, Magkos F, Reeds DN, Klein S, Mittendorfer B. Protein Ingestion Induces Muscle Insulin Resistance Independent of Leucine-Mediated mTOR Activation. Diabetes. 2015 May;64(5):1555-63. doi: 10.2337/db14-1279. Epub 2014 Dec 4.

    PubMed 25475435

  • Smith GI, Commean PK, Reeds DN, Klein S, Mittendorfer B. Effect of Protein Supplementation During Diet-Induced Weight Loss on Muscle Mass and Strength: A Randomized Controlled Study. Obesity (Silver Spring). 2018 May;26(5):854-861. doi: 10.1002/oby.22169.

    PubMed 29687650

  • Harris LLS, Smith GI, Patterson BW, Ramaswamy RS, Okunade AL, Kelly SC, Porter LC, Klein S, Yoshino J, Mittendorfer B. Alterations in 3-Hydroxyisobutyrate and FGF21 Metabolism Are Associated With Protein Ingestion-Induced Insulin Resistance. Diabetes. 2017 Jul;66(7):1871-1878. doi: 10.2337/db16-1475. Epub 2017 May 4.

    PubMed 28473464

Questions about this trial

What is this clinical trial studying?

A study testing Weight loss with normal protein intake and Weight loss with protein supplementation in people with Obesity and Menopause, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01538836, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2017.

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