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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03352583
Other study ID # 18896
Secondary ID
Status Completed
Phase N/A
First received November 16, 2017
Last updated November 20, 2017
Start date September 1, 2016
Est. completion date November 18, 2016

Study information

Verified date November 2017
Source Texas Woman's University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date November 18, 2016
Est. primary completion date November 18, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Protein
40g calcium caseinate

Locations

Country Name City State
United States Texas Woman's University Denton Texas

Sponsors (1)

Lead Sponsor Collaborator
Texas Woman's University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in lean soft tissue estimation of muscle mass by DXA pre to post over 10 weeks
Primary Changes in squat 1 repetition maximum measure of lower body strength pre to post over 10 weeks
Primary Changes in bench press 1 repetition maximum measure of upper body strength pre to post over 10 weeks
Secondary changes in fat mass estimation of body fat by DXA pre to post over 10 weeks
Secondary changes in percent body fat estimation of body fat by DXA pre to post over 10 weeks
Secondary changes in quadriceps cross-sectional area measure of muscle hypertrophy pre to post over 10 weeks
Secondary changes in quadriceps muscle thickness measure of muscle size pre to post over 10 weeks
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