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

Impaired Glucose Tolerance Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02066948
• Other study ID #: 1307013804
• 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
• 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

Related Conditions & MeSH terms

• Body Composition, Beneficial
• Glucose Intolerance
• Impaired Glucose Tolerance
• Paresis

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

External Links

•   Click here for more information about this study: Effects of dietary protein patterning on weight loss and resistance training-induced changes in body composition, skeletal muscle, and indices of metabolic syndrome