Overview

This trial is active, not recruiting.

Conditions body composition, beneficial, paresis, impaired glucose tolerance
Treatments wt loss, meal pattern, even, skew
Sponsor Purdue University
Collaborator National Pork Board
Start date January 2014
End date November 2015
Trial size 40 participants
Trial identifier NCT02066948, 1307013804

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose basic science
Arm
(Active Comparator)
Skew meal pattern w/ wt loss&exercise e
wt loss
subjects will consume a 750 reduced calorie daily diet based on current ht. wt and age
meal pattern
Even or skewed distribution of protein for a 16 week period of wt loss.
meal pattern skew or even
skew or even
even
even amount of protein distributed between each meal
(Active Comparator)
even meal pattern w/ wt loss&exercise
wt loss
subjects will consume a 750 reduced calorie daily diet based on current ht. wt and age
meal pattern
Even or skewed distribution of protein for a 16 week period of wt loss.
meal pattern skew or even
skew or even
skew
a skewed amount of protein is distributed between each meal

Primary Outcomes

Measure
Body composition
time frame: 20 weeks
Body composition
time frame: 20 weeks

Secondary Outcomes

Measure
Whole body Imaging
time frame: 20 weeks

Eligibility Criteria

Male or female participants from 19 years up to 50 years old.

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

Additional Information

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
Principal investigator Wayne W Campbell, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Purdue University.