NCT03352583

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 24, 2017

Completed
Last Updated

November 24, 2017

Status Verified

November 1, 2017

Enrollment Period

3 months

First QC Date

November 16, 2017

Last Update Submit

November 20, 2017

Conditions

Outcome Measures

Primary Outcomes (3)

  • Changes in lean soft tissue

    estimation of muscle mass by DXA

    pre to post over 10 weeks

  • Changes in squat 1 repetition maximum

    measure of lower body strength

    pre to post over 10 weeks

  • Changes in bench press 1 repetition maximum

    measure of upper body strength

    pre to post over 10 weeks

Secondary Outcomes (4)

  • changes in fat mass

    pre to post over 10 weeks

  • changes in percent body fat

    pre to post over 10 weeks

  • changes in quadriceps cross-sectional area

    pre to post over 10 weeks

  • changes in quadriceps muscle thickness

    pre to post over 10 weeks

Study Arms (2)

Day

ACTIVE COMPARATOR

Group receives casein protein during the day (greater than 6 hours before bed).

Dietary Supplement: Protein

Night

EXPERIMENTAL

Group receives casein protein immediately before going to bed.

Dietary Supplement: Protein

Interventions

ProteinDIETARY_SUPPLEMENT

40g calcium caseinate

DayNight

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy
  • trained (exercises 2-5 days per week for previous 1-3 years)
  • maintains regular sleep patterns (7-9 hours per night weekly average)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Woman's University

Denton, Texas, 76204, United States

Location

Related Publications (1)

  • Joy JM, Vogel RM, Shane Broughton K, Kudla U, Kerr NY, Davison JM, Wildman REC, DiMarco NM. Daytime and nighttime casein supplements similarly increase muscle size and strength in response to resistance training earlier in the day: a preliminary investigation. J Int Soc Sports Nutr. 2018 May 15;15(1):24. doi: 10.1186/s12970-018-0228-9.

MeSH Terms

Interventions

Proteins

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Research Assistant

Study Record Dates

First Submitted

November 16, 2017

First Posted

November 24, 2017

Study Start

September 1, 2016

Primary Completion

November 18, 2016

Study Completion

November 18, 2016

Last Updated

November 24, 2017

Record last verified: 2017-11

Locations