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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Purdue University
Sponsor:
Collaborators:
National Pork Board
American Egg Board
Dairy Research Institute
National Cattlemen's Beef Association
Information provided by (Responsible Party):
Wayne Campbell, Purdue University
ClinicalTrials.gov Identifier:
NCT02066948
First received: September 12, 2013
Last updated: February 18, 2014
Last verified: September 2013
  Purpose

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).


Condition Intervention
Body Composition, Beneficial
Paresis
Impaired Glucose Tolerance
Other: wt loss
Other: Meal Pattern
Other: meal pattern
Dietary Supplement: even
Dietary Supplement: skew

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Purdue University:

Primary Outcome Measures:
  • Body composition [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    A total of 2 magnetic resonance imaging (MRI) images of muscle and 1 MRI of the abdomen will be obtained


Other Outcome Measures:
  • Aerobic Fitness and Muscle Strength Assessment [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 40
Study Start Date: January 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Skew meal pattern w/ wt loss&exercise
Skew meal pattern w/ wt loss&exercise e
Other: wt loss
subjects will consume a 750 reduced calorie daily diet based on current ht. wt and age
Other: Meal Pattern
Even or skewed distribution of protein for a 16 week period of wt loss.
Other: meal pattern
skew or even
Other Name: skew or even
Dietary Supplement: even
even amount of protein distributed between each meal
Active Comparator: even meal pattern w/ wt loss&exercise
even meal pattern w/ wt loss&exercise
Other: wt loss
subjects will consume a 750 reduced calorie daily diet based on current ht. wt and age
Other: Meal Pattern
Even or skewed distribution of protein for a 16 week period of wt loss.
Other: meal pattern
skew or even
Other Name: skew or even
Dietary Supplement: skew
a skewed amount of protein is distributed between each meal

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.

  Eligibility

Ages Eligible for Study:   19 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02066948

Contacts
Contact: Wayne W Campbell, Ph.D 765-494-8236 campbellw@purdue.edu
Contact: Jung Eun Kim, Ph.D, R.D 765-494-7922 kim1507@purdue.edu

Locations
United States, Indiana
Purdue University Recruiting
West Lafayette, Indiana, United States, 47907
Contact: Wayne W Campbell, Ph.D    765-494-8236    campbellw@purdue.edu   
Contact: Jung Eun Kim, Ph.D, R.D    765-494-7922    kim1507@purdue.edu   
Principal Investigator: Wayne W Campbell, Ph.D         
Sponsors and Collaborators
Purdue University
National Pork Board
American Egg Board
Dairy Research Institute
National Cattlemen's Beef Association
Investigators
Principal Investigator: Wayne W Campbell, Ph.D. Purdue University
  More Information

Additional Information:
No publications provided

Responsible Party: Wayne Campbell, Professor, Foods and Nutrition, Purdue University
ClinicalTrials.gov Identifier: NCT02066948     History of Changes
Other Study ID Numbers: 1307013804
Study First Received: September 12, 2013
Last Updated: February 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Purdue University:
DXA
MRI
Fitness assessment
Meal tolerance test

Additional relevant MeSH terms:
Glucose Intolerance
Glucose Metabolism Disorders
Hyperglycemia
Metabolic Diseases

ClinicalTrials.gov processed this record on November 24, 2014