NCT02297646

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Aug 2012

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

August 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
12 months until next milestone

First Posted

Study publicly available on registry

November 21, 2014

Completed
Last Updated

November 21, 2014

Status Verified

November 1, 2014

Enrollment Period

1.3 years

First QC Date

September 10, 2013

Last Update Submit

November 20, 2014

Conditions

Health StatusMaximal and Submaximal Parameters of Physical Performance

Keywords

PreventionExerciseHealthEndurance

Outcome Measures

Primary Outcomes (1)

  • Maximum oxygen consumption (VO2max)

    VO2max

    24 weeks

Secondary Outcomes (5)

  • Numerous serum parameters from venous blood (LDL, HDL, Cholesterol, Triglycerides)

    24 weeks

  • Resting heart rate

    24 weeks

  • Resting blood pressure

    24 weeks

  • Body fat (Skinfold thickness)

    24 weeks

  • Ventilatory anaerobic threshold (VT)

    24 weeks

Study Arms (2)

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

Endurance TrainingBEHAVIORAL
Also known as: 4 sessions a week at 70 percent heart rate reserve
CarbohydratesControl

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Sports and Preventive Medicine, Saarland University

Saarbrücken, Saarland, 66012, Germany

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Endurance Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Tim Meyer, M.D. Prof.

    Universität des Saarlandes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

September 10, 2013

First Posted

November 21, 2014

Study Start

August 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

November 21, 2014

Record last verified: 2014-11

Locations

DE(1)