Influencing Factors on Training Efficacy in Healthy Adults | NCT02297646

Studies
Influencing Factors on Training Efficacy in Healthy Adults

NCT02297646

Sponsor

Universität des Saarlandes

Status

Completed

Last Update Posted

Nov 21, 2014Estimated

Enrollment

23Actual

Phase

Early Phase 1

Conditions

Health Status
Maximal and Submaximal Parameters of Physical Performance

Interventions

Endurance Training

Countries

Germany

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

Nov 2014

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 2012

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Sep 10, 2013

First Submission Date that Met QC Criteria

Nov 20, 2014

First Posted Date

Nov 21, 2014Estimated

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

Nov 20, 2014

Last Update Posted Date

Nov 21, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of this study is to investigate the effects of carbohydrate intake on training efficacy and health parameters of an endurance training program in healthy adults.

Detailed Description

Carbohydrate availability in endurance exercise seems to attenuate exercise-induced perturbations of cellular homeostasis and consequently diminishes the stimulus for training adaptation. Therefore, a negative relationship with exercise efficacy seems plausible. However, experimental evidence is rare and far from conclusive. Therefore, the present study aims to test the influence of carbohydrate intake on the efficacy of a typical preventive training program.

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

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Carbohydrates	Experimental	50 grams of carbohydrates 4 times a week for each training session	Behavioral: Endurance Training
Control	Placebo Comparator	no carbohydrate intake	Behavioral: Endurance Training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endurance Training	Behavioral		Carbohydrates Control	4 sessions a week at 70 percent heart rate reserve

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum oxygen consumption (VO2max)	VO2max	24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Numerous serum parameters from venous blood (LDL, HDL, Cholesterol, Triglycerides)	cardiovascular parameters: LDL HDL Cholesterol Triglycerides	24 weeks
Resting heart rate		24 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

no diseases
nonsmoker
BMI 25-30 kg/m²
blood pressure <160/100 mm/Hg
unmedicated
untrained status
V̇O2max < 50 mL/kg/min

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tim Meyer, M.D. Prof.	Universität des Saarlandes	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Sports and Preventive Medicine, Saarland University		Saarbrücken	Saarland	66012	Germany

ID	Term
D009043	Motor Activity

ID	Term
D001519	Behavior

Intervention Browse Module

MeSH Terms

ID	Term
D000076663	Endurance Training

Ancestor Terms

ID	Term
D005081	Exercise Therapy
D012046	Rehabilitation
D000359	Aftercare
D003266	Continuity of Patient Care

Browse Leaves

Not provided

Browse Branches

Not provided