NCT01538836

Brief 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 mineral density in obese, postmenopausal women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 24, 2012

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 27, 2017

Status Verified

March 1, 2017

Enrollment Period

5.2 years

First QC Date

February 20, 2012

Last Update Submit

March 22, 2017

Conditions

ObesityMenopauseOsteoporosisSarcopenia

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (3)

Weight maintenance

NO INTERVENTION

Weight maintenance with normal protein intake

Weight loss with normal protein intake

ACTIVE COMPARATOR
Behavioral: Weight loss with normal protein intake

Weight loss with protein supplementation

EXPERIMENTAL
Behavioral: Weight loss with protein supplementation

Interventions

Weight loss with normal protein intakeBEHAVIORAL

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 normal protein intake
Weight loss with protein supplementationBEHAVIORAL

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).

Weight loss with protein supplementation

Eligibility Criteria

Age50 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (7)

  • 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.

    PMID: 19208352BACKGROUND

  • 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.

    PMID: 26607940BACKGROUND

  • 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.

    PMID: 27732859RESULT

  • 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.

    PMID: 26150260RESULT

  • 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.

    PMID: 25475435RESULT

  • 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.

    PMID: 29687650DERIVED

  • 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.

    PMID: 28473464DERIVED

MeSH Terms

Conditions

ObesityOsteoporosisSarcopenia

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, Anatomical

Study Officials

  • Bettina Mittendorfer, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2012

First Posted

February 24, 2012

Study Start

January 1, 2012

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

March 27, 2017

Record last verified: 2017-03

Locations

US(1)