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Completed

NCT Number: NCT02066948

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

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

wt loss

Other

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

Meal Pattern

Other

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

even

Dietary Supplement

even amount of protein distributed between each meal

skew

Dietary Supplement

a skewed amount of protein is distributed between each meal

Primary outcomes

  1. Body composition

    Time frame: 20 weeks

    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).

  2. Body composition

    Time frame: 20 weeks

    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 outcomes

  1. Whole body Imaging

    Time frame: 20 weeks

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

Other outcomes

  1. Aerobic Fitness and Muscle Strength Assessment

    Time frame: 20 weeks

    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

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Collaborators

  • American Egg Board
  • Dairy Research Institute
  • National Cattlemen's Beef Association, a contractor to the Beef Checkoff
  • National Pork Board

Registry information

Official study title

Effects of Dietary Protein Patterning on wt Loss and Resistance Training-induced Changes in Body Comp, Skeletal Muscle, and Indices of Metabolic Syndrome

Acronym: S38

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 20, 2014
Registry last updated
Jun 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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