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Meal Patterning on Weight Loss With Changes to Body Comp, Muscle and Metabolic Health (S38)

Primary Purpose

Body Composition, Beneficial, Paresis, Impaired Glucose Tolerance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
wt loss
Meal Pattern
meal pattern
even
skew
Sponsored by
Purdue University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Body Composition, Beneficial focused on measuring DXA, MRI, Fitness assessment, Meal tolerance test

Eligibility Criteria

19 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Purdue University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Skew meal pattern w/ wt loss&exercise

even meal pattern w/ wt loss&exercise

Arm Description

Skew meal pattern w/ wt loss&exercise e

even meal pattern w/ wt loss&exercise

Outcomes

Primary Outcome Measures

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).
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

Secondary Outcome Measures

Whole body Imaging
A total of 2 magnetic resonance imaging (MRI) images of muscle and 1 MRI of the abdomen will be obtained

Full Information

First Posted
September 12, 2013
Last Updated
May 31, 2017
Sponsor
Purdue University
Collaborators
National Pork Board, American Egg Board, Dairy Research Institute, National Cattlemen's Beef Association
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1. Study Identification

Unique Protocol Identification Number
NCT02066948
Brief Title
Meal Patterning on Weight Loss With Changes to Body Comp, Muscle and Metabolic Health
Acronym
S38
Official Title
Effects of Dietary Protein Patterning on wt Loss and Resistance Training-induced Changes in Body Comp, Skeletal Muscle, and Indices of Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Purdue University
Collaborators
National Pork Board, American Egg Board, Dairy Research Institute, National Cattlemen's Beef Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
About two-thirds of adults in the United States are overweight or obese. Obesity is associated with an increased risk of chronic disease and metabolic syndrome and a reduced physical functioning capacity, all of which contribute to disproportionately high healthcare expenditures and premature mortality. A moderate dietary energy restriction with a higher protein diet has been recommended for weight loss to prevent or improve medical complications associated with obesity as well as improve body composition, including preserving lean body mass. Emerging research indicates that the consumption of multiple high protein meals daily may be superior than only consuming one high-protein meal (typically dinner) to stimulate muscle protein synthesis throughout the day. This concept is based on research showing that the patterning of energy and protein intake influences muscle protein synthesis and whole body composition and protein retention. Very limited research exists regarding the effects of protein intake on skeletal muscle size after weight loss, and currently, no longitudinal studies have evaluated the effectiveness of consuming an even vs. skewed distribution of protein intake across meals on phenotypic changes in skeletal muscle size over the longer-term. Recent studies have also suggested that evenly distributed protein patterning may promote satiety and improve blood glucose response in healthy adult men and women. However, there is a need for controlled, longer-duration trials to investigate the effects of daily protein distribution on appetite, glucose response and metabolic syndrome after weight loss in overweight or obese adults. The goal of the proposed research is to evaluate the effects of within-day patterning of dietary protein intake (even vs. skewed) on energy-restriction and resistance training-induced changes in body composition, skeletal muscle size, appetite, glucose response, and metabolic syndrome parameters.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Composition, Beneficial, Paresis, Impaired Glucose Tolerance
Keywords
DXA, MRI, Fitness assessment, Meal tolerance test

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Skew meal pattern w/ wt loss&exercise
Arm Type
Active Comparator
Arm Description
Skew meal pattern w/ wt loss&exercise e
Arm Title
even meal pattern w/ wt loss&exercise
Arm Type
Active Comparator
Arm Description
even meal pattern w/ wt loss&exercise
Intervention Type
Other
Intervention Name(s)
wt loss
Intervention Description
subjects will consume a 750 reduced calorie daily diet based on current ht. wt and age
Intervention Type
Other
Intervention Name(s)
Meal Pattern
Intervention Description
Even or skewed distribution of protein for a 16 week period of wt loss.
Intervention Type
Other
Intervention Name(s)
meal pattern
Other Intervention Name(s)
skew or even
Intervention Description
skew or even
Intervention Type
Dietary Supplement
Intervention Name(s)
even
Intervention Description
even amount of protein distributed between each meal
Intervention Type
Dietary Supplement
Intervention Name(s)
skew
Intervention Description
a skewed amount of protein is distributed between each meal
Primary Outcome Measure Information:
Title
Body composition
Description
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).
Time Frame
20 weeks
Title
Body composition
Description
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
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Whole body Imaging
Description
A total of 2 magnetic resonance imaging (MRI) images of muscle and 1 MRI of the abdomen will be obtained
Time Frame
20 weeks
Other Pre-specified Outcome Measures:
Title
Aerobic Fitness and Muscle Strength Assessment
Description
An aerobic fitness will be assessed by submaximal aerobic capacity test and a maximal muscle strength will be examined using a one-repetition maximum test
Time Frame
20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Smoker weight changed within 3 months a history of disease or high risk of cardiovascular disease history of claustrophobic pregnant or lactating female
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wayne W Campbell, Ph.D.
Organizational Affiliation
Purdue University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Purdue University
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47907
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28903957
Citation
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.
Results Reference
derived

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Meal Patterning on Weight Loss With Changes to Body Comp, Muscle and Metabolic Health

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