NCT01538836|CompletedDMC
Calorie Restriction, Protein Supplementation and Metabolic Health
CRPS
Calorie Restriction and Metabolic Health
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CRPS
Calorie Restriction and Metabolic Health
Sponsor study identifier
Secondary identifiers
interventional
75
1 country
1
Study Start
January 2012
Actual (reported)Primary Completion
March 2017
Actual (reported)Study Completion
March 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2012
Actual (reported)February 20, 2012
Actual (reported)February 24, 2012
Actual (reported)March 2017
Actual (reported)March 2017
Actual (reported)Change in muscle volume
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
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
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
Change in insulin sensitivity
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
Baseline and at 5% weight loss in the calorie restriction groups and after ~3 months in the weight maintenance group
Change in bacterial populations found in the stool
Baseline and at 10% weight loss in calorie restriction groups and ~6 to 7 months in the weight maintenance group
Change in cell proliferation (growth) rates in the colon
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
Prior to starting the weight loss or maintenance intervention
Weight maintenance 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).
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).
Washington University School of Medicine
St Louis, Missouri, 63110, United States
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.
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.
Bettina Mittendorfer, PhD
Washington University School of Medicine
75 participants (actual enrollment reported by the registry).
First Submitted
February 20, 2012
First Posted
February 24, 2012
Study Start
January 2012
Actual (reported)Progressive Weight Loss and Metabolic Health
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
Primary Completion
March 2017
Actual (reported)Study Completion
March 2017
Actual (reported)Last Updated
March 27, 2017
Record last verified: 2017-03
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Source: ClinicalTrials.gov.
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