Protein Intake and Physical Performance

October 30, 2015 updated by: Skidmore College

Effects of Increased Protein Intake and Exercise Training on Body Composition, Cardiovascular Health and Physical Performance

A primary aim of the current proposal is to compare the effect of daily consumption of healthy lean protein as either whey protein (2 meals per day) or whole food (25% of total daily caloric intake) consumed as 6 small meals throughout the day, one of which is consumed immediately following exercise training (within 30 min) and another 2 hours prior to going to bed at night, over a 16 week period on muscle and fat mass, cardiovascular health, aerobic fitness, glucose, insulin, blood lipids, heart rate and muscle strength in overweight men and women.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The primary purpose of this study is to examine the effects of increased healthy protein intake (25% of daily caloric intake as protein; 25% as healthy fats and oils; 50% as complex, unrefined carbohydrates) consumed as 6 small meals during the day in combination with exercise training 4 times per week, over a 16 week period in 25 overweight, but healthy males and females (30-60 yrs old). A secondary purpose is to compare the effects of consuming two of the 6 small meals during the day comprised of whole food protein source servings 20g/serving) with a matched group consuming whey protein for 2 daily protein servings (20g/serving). In the case of both groups, 1 serving will be consumed immediately following exercise [within 30 minutes] and 1 serving will be consumed 2 hours before going to bed. On non-exercise days, all participants will continue to consume 6 small meals per day in the same ratio of 25% lean protein, 25% healthy fats and oils, and 50% complex, unrefined carbohydrates but the groups will differ only in the composition of the last meal of the day consumed 2 hours before going to bed in which one group will consume protein (20g/serving) as whole food protein sources and the other group will consume a single serving of a whey protein supplement. The primary purpose of this study is to quantify changes in the following health outcomes at baseline and 16 weeks: total body muscle mass and fat mass (iDXA); abdominal fat mass (most highly related to cardiovascular and metabolic disease risk); blood sugar (glucose); blood lipids; insulin, aerobic fitness (assessed with a submaximal exercise test); and muscular strength (measured by 1 repetition maximum (RM) of the chest and leg press). The following additional measures will be assessed at baseline and 16 weeks: waist circumference; body weight, heart rate, blood pressure, and hunger (Visual Analog Scales).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Each participant was screened prior to participating in the study using the Health and Fitness History, Physical Activity, and Physical Activity Readiness questionnaires administered by the investigators.
  • Medical clearance was secured from the participant's primary care physician to verify no cardiovascular,metabolic or orthopedic issues that would prohibit them from performing the exercises for the duration of the study period
  • Depending on the outcome of the health history, fitness and activity questionnaires and the physician's clearance, participants were informed of eligibility to participate in the study. A group meeting was scheduled for all eligible and interested participants to review the entire study. This process took place prior to administering any tests.

Exclusion Criteria:

  • Participants were excluded if they smoked, had a whey protein intolerance, or orthopedic conditions that prohibited them from engaging in strenuous exercise

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Whey Protein and exercise training
Six meals per day of 20 grams of protein, two of which were whey protein and 4 days per week of exercise training..
Behavioral: Whey Protein and exercise training
Six meals per day four of which were whole food and two of whey protein for an overall percentage of macronutrient intake of 25% protein and 4 days per week of exercise training
Experimental: Food Protein and exercise training
Six meals per day of 20 grams of protein, all of which were whole food protein and 4 days per week of exercise training.
Behavioral: Food Protein and exercise training
Six meals per day all of which were whole food protein for an overall percentage of macronutrient intake of 25% protein and 4 days per week of exercise training

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Athletic Performance
Time Frame: baseline and post 16 week intervention
Changes in one repetition maximum muscular strength of upper and lower body
baseline and post 16 week intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total and Regional Body Composition
Time Frame: baseline and post 16 week intervention
Changes in total and regional body fat assessed by dual energy xray
baseline and post 16 week intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cardiometabolic Hormones
Time Frame: baseline and post 16 week intervention
Changes in plasma insulin levels
baseline and post 16 week intervention
Aerobic Fitness
Time Frame: baseline and post 12 week intervention
Changes in oxygen consumption
baseline and post 12 week intervention
Hunger Ratings
Time Frame: baseline and post 12 week intervention
Changes in hunger visual analog scale ratings
baseline and post 12 week intervention
Blood Lipids
Time Frame: baseline and post 12 week intervention
Changes in total, LDL, HDL cholesterol
baseline and post 12 week intervention
Blood Pressure
Time Frame: baseline and post 12 week intervention
Changes in systolic and diastolic blood pressure
baseline and post 12 week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Skidmore College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 3, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 3, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1012-227

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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