- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02593656
Effects of Protein Ingestion and Exercise Training on Muscular Performance
Effects of Frequent, High Quality, Multi-Ingredient Protein Meals and Exercise Training on Hormones, Body Composition, Muscular Performance, and Energy Metabolism in Active Healthy Men and Women
This study systematically quantified the effects of a protein pacing energy and performance (IEPS) meal pattern compared to a standard recommended control (C) diet both of which were combined with a 4-day/week exercise training program on total and regional (abdominal) body composition (lean mass and fat mass), muscular strength and performance, flexibility, blood lipids and glucose, hormones, mood state and energy metabolism in 60 healthy middle-aged (25-55 years old) men and women following a 12-week intervention. Participants were enrolled in one of two cohorts:
- Experimental, 2g/kg/Body Weight (BW) Protein (IEPS) (n=30)
- Control, 1g/kg/Body Weight Protein (C) (n=30)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants were matched for body weight, body mass index (BMI) and percent body fat (%BF) and then randomly assigned to one of two groups: (1) Experimental 2.0 g/kg Body Weight per day of protein and combined exercise training (IEPS, n=30); or (2) a control (C) diet containing 1.0 g/kg Body Weight per day of protein and combined exercise training (C, n=30). All participants followed a program of progressive exercise training for 12 weeks performed either in the early morning (0600-0800, AM) or evening (1830-2030, PM). All testing procedures (see below) were administered pre-intervention and post intervention.
Participants in both groups were provided meal plans and instructed to follow the meal plans throughout the intervention. Participants in the IEPS were provided two shakes and 1 bar meal replacement each day to help them meet the 2.0 g/kg Body Weight of protein per day. Participants were given a 2-wk supply of the supplement and asked to return the empty packets before they received the next two-week's supply as a means of assessing their compliance. C participants were required to follow a healthy meal plan providing 1.0 g/kg Body Weight of protein per day by consuming whole foods for all of their meals. They were not provided additional protein supplements. However, they were provided food supplies consisting of granola bars, chocolate milk, and fruit to help them meet their 1.0 g/kg BW protein per day. They were also asked to return empty food packets to monitor compliance. Similar dietary interventions to the two proposed in this study have been used successfully in the past by the PI with no adverse events being reported.
Prior to the start of the study, each subject was familiarized with the exercise training protocols by participating in eight supervised exercise sessions over a two-week period (4 times per week) in the Skidmore College fitness and weight training rooms located adjacent to the Health & Exercise Sciences Department. Participants were asked to perform all the exercise sessions at Skidmore College for the first two weeks and had the option to perform one or two of the exercises (I, E) on their own at home or at their local gym following the two week familiarization. Participants were required to perform 4 exercise sessions per week of the following exercises: a) resistance training (R); b) interval sprint training (I); c) stretching training (S); and d) endurance training (E). During the course of the interventions, a member of the research team periodically "checked-in" (weekly) with each participant by phone, email, or in-person to answer any questions or provide guidance with the exercise and dietary intake. All exercise training guidelines and recommendations followed the American College of Sports Medicine, such that their exercise intensity will be based on their individual fitness level and health status.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participants will be non-smoking, healthy, men and women with no known cardiovascular or metabolic diseases as assessed by a medical history and approval by their physicians to participate. All participants will be active (>30 min, 4d/wk of structured physical activity > 3 years) as assessed by a Physical Activity questionnaire, normal weight (BMI=20-27.5 kg/m2; % body fat<30%), middle aged (25-55 years), and weight stable (+/-2kg) for at least 6 months prior to beginning the study
Exclusion Criteria:
- Individuals will be excluded from participation for the following reasons: orthopedic conditions that preclude or limit participation in the exercise training (RISE); history of cardiometabolic disease (e.g., diabetes, heart disease, etc.) and/or cancer; pregnant or may be pregnant; or allergic to milk products.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: High Protein
Ingestion of 2.0 grams of protein per kilogram of body weight per day combined with exercise training
|
Protein-pacing throughout the day and exercise training for 12 weeks
|
ACTIVE_COMPARATOR: Normal Protein
Ingestion of 1.0 gram of protein per kilogram of body weight per day combined with exercise training
|
Normal protein intake throughout the day and exercise training for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscular Strength and Power
Time Frame: baseline and post 12 week intervention
|
Changes in one repetition muscular strength and power of upper and lower body
|
baseline and post 12 week intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total and Regional Body Composition
Time Frame: baseline and post 12 week intervention
|
Changes in total and abdominal body fat and lean body mass by dual energy xray
|
baseline and post 12 week intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Arterial function
Time Frame: baseline and post 12 week intervention
|
Changes in arterial stiffness
|
baseline and post 12 week intervention
|
Blood Lipids
Time Frame: baseline and post 12 week intervention
|
Changes in total, LDL, and HDL cholesterol
|
baseline and post 12 week intervention
|
Energy Metabolism
Time Frame: baseline and post 12 week intervention
|
Changes in resting metabolic rate and substrate utilization via indirect calorimetry
|
baseline and post 12 week intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1401-382
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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