Physical PerformanceNCT02593656
Effects of Protein Ingestion and Exercise Training on Muscular Performance
A study testing High Protein and Normal Protein in people with Physical Performance, run by Skidmore College.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Performance
- What is being tested?
- High Protein and Normal Protein
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: 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)
Read the 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.
- Conditions
- Physical Performance
- Being tested
- High Protein, Normal Protein
- Keywords
- protein ingestion, resistance exercise, interval exercise, stretching exercise, endurance exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High ProteinBehavioural
Protein-pacing throughout the day and exercise training for 12 weeks
Normal ProteinBehavioural
Normal protein intake throughout the day and exercise training for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| High Protein | Experimental | Ingestion of 2.0 grams of protein per kilogram of body weight per day combined with exercise training Receives: Behavioral: High Protein |
| Normal Protein | Active comparator | Ingestion of 1.0 gram of protein per kilogram of body weight per day combined with exercise training Receives: Behavioral: Normal Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscular Strength and Power
Changes in one repetition muscular strength and power of upper and lower body
Measured: baseline and post 12 week intervention
Secondary outcomes (1)
Total and Regional Body Composition
Changes in total and abdominal body fat and lean body mass by dual energy xray
Measured: baseline and post 12 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2015 (estimated)
- Study startJan 2015
- Primary completionMay 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical PerformanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skidmore College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul J Arciero, Phd, Principal investigator, Skidmore College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02593656
- Sponsor's protocol ID
- 1401-382
- Status last verified
- Apr 2022
- First submitted
- 29 Oct 2015
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02593656
- Acronym / sponsor ID
- 1401-382
- Conditions
- Physical Performance
- Keywords
- protein ingestion, resistance exercise, interval exercise, stretching exercise, endurance exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Skidmore CollegeUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- May 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 2 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Protein | Experimental | Behavioral: High ProteinIngestion of 2.0 grams of protein per kilogram of body weight per day combined with exercise training |
| Normal Protein | Active comparator | Behavioral: Normal ProteinIngestion of 1.0 gram of protein per kilogram of body weight per day combined with exercise training |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High ProteinProtein-pacing throughout the day and exercise training for 12 weeks | Behavioural | High Protein |
| Normal ProteinNormal protein intake throughout the day and exercise training for 12 weeks | Behavioural | Normal Protein |
Primary outcome
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
1 secondary outcome
Total and Regional Body Composition
Time frame: baseline and post 12 week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul J Arciero, Phd principal investigator
Skidmore College
Questions about this trial
What is this clinical trial studying?
A study testing High Protein and Normal Protein in people with Physical Performance, run by Skidmore College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscular Strength and Power (time frame: baseline and post 12 week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.