NCT02066948

Brief Summary

About two-thirds of adults in the United States are overweight or obese with likely adverse health consequences. A Moderate weight loss by dieting and exercise is recommended to improve health. We are interested to know whether eating dietary protein at different times of the day influences changes in body composition, muscle and indices of health. The purpose of this study is to examine the effects of within-day patterning of dietary protein intake (even vs. skewed) on energy-restriction and resistance training-induced changes in body composition, muscle size, appetite, and clinical health (including blood glucose and blood pressure).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

September 12, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 20, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

June 1, 2017

Status Verified

January 1, 2017

Enrollment Period

1.8 years

First QC Date

September 12, 2013

Last Update Submit

May 31, 2017

Conditions

Body Composition, BeneficialParesisImpaired Glucose Tolerance

Keywords

DXAMRIFitness assessmentMeal tolerance test

Outcome Measures

Primary Outcomes (2)

  • Body composition

    Fasting-state body weight and waist and hip circumferences will be measured. Body composition (fat mass, lean body mass, and bone mass) will also be determined using Dual Energy X-ray Absorptiometry (DXA, GE Healthcare LUNAR iDXA™ with EnCORE software version 5.60, Madison, WI).

    20 weeks

  • Body composition

    Fasting-state body weight and waist and hip circumferences will be measured. Body composition (fat mass, lean body mass, and bone mass) will also be determined using Dual Energy X-ray Absorptiometry

    20 weeks

Secondary Outcomes (1)

  • Whole body Imaging

    20 weeks

Other Outcomes (1)

  • Aerobic Fitness and Muscle Strength Assessment

    20 weeks

Study Arms (2)

Skew meal pattern w/ wt loss&exercise

ACTIVE COMPARATOR

Skew meal pattern w/ wt loss\&exercise e

Other: wt lossOther: Meal PatternDietary Supplement: even

even meal pattern w/ wt loss&exercise

ACTIVE COMPARATOR

even meal pattern w/ wt loss\&exercise

Other: wt lossOther: Meal PatternDietary Supplement: skew

Interventions

wt lossOTHER

subjects will consume a 750 reduced calorie daily diet based on current ht. wt and age

Skew meal pattern w/ wt loss&exerciseeven meal pattern w/ wt loss&exercise
meal patternOTHER

Even or skewed distribution of protein for a 16 week period of wt loss.

Skew meal pattern w/ wt loss&exerciseeven meal pattern w/ wt loss&exercise
evenDIETARY_SUPPLEMENT

even amount of protein distributed between each meal

Skew meal pattern w/ wt loss&exercise
skewDIETARY_SUPPLEMENT

a skewed amount of protein is distributed between each meal

even meal pattern w/ wt loss&exercise

Eligibility Criteria

Age19 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • non-smoking;
  • weight stable (± 4.5 kg during previous 3 months)
  • constant habitual activity patterns within last 3 months
  • no acute illness
  • not diabetic or have chronic diseases
  • blood profile within 10% of clinical normalcy
  • subjects not classified as high risk for cardiovascular disease
  • no use of medications
  • females who are not pregnant or lactating
  • ability to travel to testing and exercise training facilities
  • not claustrophobic and able to complete the muscle size testing using the magnetic resonance imager

You may not qualify if:

  • Smoker
  • weight changed within 3 months
  • a history of disease or high risk of cardiovascular disease
  • history of claustrophobic
  • pregnant or lactating female

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

Related Publications (1)

  • Hudson JL, Kim JE, Paddon-Jones D, Campbell WW. Within-day protein distribution does not influence body composition responses during weight loss in resistance-training adults who are overweight. Am J Clin Nutr. 2017 Nov;106(5):1190-1196. doi: 10.3945/ajcn.117.158246. Epub 2017 Sep 13.

    PMID: 28903957DERIVED

MeSH Terms

Conditions

Glucocorticoid Receptor DeficiencyParesisGlucose Intolerance

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Wayne W Campbell, Ph.D.

    Purdue University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Foods and Nutrition

Study Record Dates

First Submitted

September 12, 2013

First Posted

February 20, 2014

Study Start

January 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

June 1, 2017

Record last verified: 2017-01

Locations

US(1)