Protein Before Night Sleep to Improve Recovery and Perfor... | NCT03147833

Studies
Protein Before Night Sleep to Improve Recovery and Performance in Runners

NCT03147833

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Jun 11, 2018Actual

Enrollment

32Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Sport beverages Protein
Sport beverages Carbohydrate

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2017Actual

Primary Completion Date

Oct 9, 2017Actual

Completion Date

Oct 9, 2017Actual

First Submitted Date

May 8, 2017

First Submission Date that Met QC Criteria

May 8, 2017

First Posted Date

May 10, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 7, 2018

Last Update Posted Date

Jun 11, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

32 runners will be randomized into two groups. The duration of the intervention is one week including a strenuous endurance training program. Group 1 receive a protein beverage before each night sleep and Group 2 receive an isocaloric carbohydrate beverage. Performance test before and after the intervention and blood sampling before and during the intervention to check for markers for muscle damage.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sport beverages Protein	Experimental	Intervention group ingesting PROTEIN	Dietary Supplement: Sport beverages Protein
Sports beverage Carbohydrate	Active Comparator	Placebo group ingesting carbohydrate	Dietary Supplement: Sport beverages Carbohydrate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sport beverages Protein	Dietary Supplement	Beverage ingested before each night sleep during the intervention	Sport beverages Protein

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Performance	5 km time trial	8 days

Secondary Outcomes

Measure	Description	Time Frame
Muscle damage	creatine kinase	8 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: VO2max >55 ml O2/kg/min -

Exclusion Criteria:women, smokers

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mette Hansen, PhD	University of Aarhus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University, Department for Public Health, Section for Sport Science		Aarhus		8000	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided