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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02066948
Other study ID # 1307013804
Secondary ID
Status Completed
Phase N/A
First received September 12, 2013
Last updated May 31, 2017
Start date January 2014
Est. completion date November 2015

Study information

Verified date January 2017
Source Purdue University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 50 Years
Eligibility 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

Study Design


Intervention

Other:
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
Dietary Supplement:
even
even amount of protein distributed between each meal
skew
a skewed amount of protein is distributed between each meal

Locations

Country Name City State
United States Purdue University West Lafayette Indiana

Sponsors (5)

Lead Sponsor Collaborator
Purdue University American Egg Board, Dairy Research Institute, National Cattlemen's Beef Association, National Pork Board

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Aerobic Fitness and Muscle Strength Assessment 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 20 weeks
Primary 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
Primary 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 Whole body Imaging A total of 2 magnetic resonance imaging (MRI) images of muscle and 1 MRI of the abdomen will be obtained 20 weeks
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