- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03352583
Effects of Casein Timing on Body Composition and Performance
November 20, 2017 updated by: Jordan Joy, Texas Woman's University
Effects of Evening Casein Protein Consumption on Body Composition and Performance
This study will investigate the effects of night time versus day time casein supplementation on body composition and athletic performance.
Participants will consume the protein supplements daily while participating in a supervised, periodized resistance training program.
Study Overview
Detailed Description
In a randomized, double-blind, placebo-, exercise- and diet-controlled design, 60 subjects will participate in a 10-week study to determine the influence of selective protein timing on body composition, metabolic, and performance adaptations to resistance training.
Diets will be individually standardized using the Cunningham equation adjusted for activity level to determine total maintenance calories.
Carbohydrates, fats, and proteins will represent 50, 25, and 25 percent of the determined total calories.
Diet counseling will occur weekly until stabilized and biweekly thereafter to ensure compliance with food and fluid intake.
Protein will be distributed throughout the day as >0.30g/kg bw/meal for breakfast, lunch, and dinner.
Resistance training sessions will be supervised by research staff and occur 4 times per week and begin between 7 am and 5pm.
Exercises will consist of single- and multi-joint exercises for all major muscle groups (legs, chest, back, shoulders, core, and arms), be performed for 3-5 sets of 1-20 repetitions with 1-5 minutes rest between sets, and each muscle group will undergo 72-96 hours rest between training sessions within the periodized program.
Protein supplements.
In the treatment group, the casein supplement (40g calcium caseinate dissolved in water) will be consumed as the last meal (>2h following previous meal) before bed and the placebo (40g maltodextrin dissolved in water) either before resistance training, if training after 10am, or after resistance training, if before 10am.
The control group will alternate consumption times of the casein supplement and placebo.
The supplement (treatment group) or placebo (control group) will not be consumed within 3 hours of beginning or ending resistance training, nor will it be consumed within 3 hours of the first meal following waking.
All groups will be provided with 0.30g/kg bw whey protein isolate immediately following training to facilitate recovery.
Supplements will be consumed at a similar time of day on non-training days.
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Denton, Texas, United States, 76204
- Texas Woman's University
-
-
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
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- healthy
- trained (exercises 2-5 days per week for previous 1-3 years)
- maintains regular sleep patterns (7-9 hours per night weekly average)
Exclusion Criteria:
- use of ergogenic aids or medicines known to influence outcomes
- data will be excluded if a participant is <80% compliant with diet and training interventions
- consumes greater than or equal to 12 alcoholic beverages per week
- tobacco use
- dairy allergy
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
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Day
Group receives casein protein during the day (greater than 6 hours before bed).
|
40g calcium caseinate
|
|
Experimental: Night
Group receives casein protein immediately before going to bed.
|
40g calcium caseinate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in lean soft tissue
Time Frame: pre to post over 10 weeks
|
estimation of muscle mass by DXA
|
pre to post over 10 weeks
|
|
Changes in squat 1 repetition maximum
Time Frame: pre to post over 10 weeks
|
measure of lower body strength
|
pre to post over 10 weeks
|
|
Changes in bench press 1 repetition maximum
Time Frame: pre to post over 10 weeks
|
measure of upper body strength
|
pre to post over 10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
changes in fat mass
Time Frame: pre to post over 10 weeks
|
estimation of body fat by DXA
|
pre to post over 10 weeks
|
|
changes in percent body fat
Time Frame: pre to post over 10 weeks
|
estimation of body fat by DXA
|
pre to post over 10 weeks
|
|
changes in quadriceps cross-sectional area
Time Frame: pre to post over 10 weeks
|
measure of muscle hypertrophy
|
pre to post over 10 weeks
|
|
changes in quadriceps muscle thickness
Time Frame: pre to post over 10 weeks
|
measure of muscle size
|
pre to post over 10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Actual)
September 1, 2016
Primary Completion (Actual)
November 18, 2016
Study Completion (Actual)
November 18, 2016
Study Registration Dates
First Submitted
November 16, 2017
First Submitted That Met QC Criteria
November 20, 2017
First Posted (Actual)
November 24, 2017
Study Record Updates
Last Update Posted (Actual)
November 24, 2017
Last Update Submitted That Met QC Criteria
November 20, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 18896
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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