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

NCT ID: NCT02066948

Last Updated: 2017-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-11-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Body Composition, Beneficial Paresis Impaired Glucose Tolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Skew meal pattern w/ wt loss&exercise

Skew meal pattern w/ wt loss\&exercise e

Group Type ACTIVE_COMPARATOR

wt loss

Intervention Type OTHER

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

Meal Pattern

Intervention Type OTHER

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

meal pattern

Intervention Type OTHER

skew or even

even

Intervention Type DIETARY_SUPPLEMENT

even amount of protein distributed between each meal

even meal pattern w/ wt loss&exercise

even meal pattern w/ wt loss\&exercise

Group Type ACTIVE_COMPARATOR

wt loss

Intervention Type OTHER

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

Meal Pattern

Intervention Type OTHER

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

meal pattern

Intervention Type OTHER

skew or even

skew

Intervention Type DIETARY_SUPPLEMENT

a skewed amount of protein is distributed between each meal

Interventions

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wt loss

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

Intervention Type OTHER

Meal Pattern

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

Intervention Type OTHER

meal pattern

skew or even

Intervention Type OTHER

even

even amount of protein distributed between each meal

Intervention Type DIETARY_SUPPLEMENT

skew

a skewed amount of protein is distributed between each meal

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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skew or even

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Pork Board

OTHER

Sponsor Role collaborator

American Egg Board

OTHER

Sponsor Role collaborator

Dairy Research Institute

OTHER

Sponsor Role collaborator

National Cattlemen's Beef Association

INDUSTRY

Sponsor Role collaborator

Purdue University

OTHER

Sponsor Role lead

Responsible Party

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Wayne Campbell

Professor, Foods and Nutrition

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wayne W Campbell, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Purdue University

Locations

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Purdue University

West Lafayette, Indiana, United States

Site Status

Countries

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United States

References

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Hudson JL, Kim JE, Paddon-Jones D, Campbell WW. Within-day protein distribution does not influence body composition responses during weight loss in resistance-training adults who are overweight. Am J Clin Nutr. 2017 Nov;106(5):1190-1196. doi: 10.3945/ajcn.117.158246. Epub 2017 Sep 13.

Reference Type DERIVED
PMID: 28903957 (View on PubMed)

Other Identifiers

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1307013804

Identifier Type: -

Identifier Source: org_study_id

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