Health StatusEarly Phase 1CHONCT02297646
Influencing Factors on Training Efficacy in Healthy Adults
A Early Phase 1 study testing Endurance Training in people with Health Status and Maximal and Submaximal Parameters of Physical Performance, run by Universität des Saarlandes at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Status, Maximal and Submaximal Parameters of Physical Performance
- What is being tested?
- Endurance Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2012to Dec 2013
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- no diseases
- nonsmoker
- BMI 25-30 kg/m²
- blood pressure <160/100 mm/Hg
- unmedicated
- untrained status
- V̇O2max < 50 mL/kg/min
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Sports and Preventive Medicine, Saarland University
Saarbrücken, Saarland, 66012
About this study
Official title: The Influence of Carbohydrates on Training Efficacy and Health Status in Healthy Adults
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.
Read the 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.
- Being tested
- Endurance Training
- Keywords
- Prevention, Exercise, Health, Endurance
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endurance TrainingBehavioural
Also called 4 sessions a week at 70 percent heart rate reserve
| Study group | Role | What they receive |
|---|---|---|
| Carbohydrates | Experimental | 50 grams of carbohydrates 4 times a week for each training session Receives: Behavioral: Endurance Training |
| Control | Placebo comparator | no carbohydrate intake Receives: Behavioral: Endurance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum oxygen consumption (VO2max)
VO2max
Measured: 24 weeks
Secondary outcomes (5)
Numerous serum parameters from venous blood (LDL, HDL, Cholesterol, Triglycerides)
cardiovascular parameters:
- LDL
- HDL
- Cholesterol
- Triglycerides
Measured: 24 weeks
Resting heart rate
Measured: 24 weeks
Resting blood pressure
Measured: 24 weeks
Body fat (Skinfold thickness)
Skinfold thickness
Measured: 24 weeks
Ventilatory anaerobic threshold (VT)
VT
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startAug 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Krieg M.D., Universität des Saarlandes
- Investigators
- Tim Meyer, M.D. Prof., Principal investigator, Universität des Saarlandes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02297646
- Sponsor's protocol ID
- Saarland University - CHO
- Acronym
- CHO
- Status last verified
- Nov 2014
- First submitted
- 10 Sep 2013
- Last updated
- 21 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Carbohydrates on Training Efficacy and Health Status in Healthy Adults
- ClinicalTrials.gov ID
- NCT02297646
- Acronym / sponsor ID
- CHO / Saarland University - CHO
- Keywords
- Prevention, Exercise, Health, Endurance
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 21 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbohydrates | Experimental | Behavioral: Endurance Training50 grams of carbohydrates 4 times a week for each training session |
| Control | Placebo comparator | Behavioral: Endurance Trainingno carbohydrate intake |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- no diseases
- nonsmoker
- BMI 25-30 kg/m²
- blood pressure <160/100 mm/Hg
- unmedicated
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endurance TrainingAlso: 4 sessions a week at 70 percent heart rate reserve | Behavioural | Carbohydrates, Control |
Primary outcome
Maximum oxygen consumption (VO2max)
Time frame: 24 weeks
VO2max
5 secondary outcomes
Numerous serum parameters from venous blood (LDL, HDL, Cholesterol, Triglycerides)
Time frame: 24 weeks
Resting heart rate
Time frame: 24 weeks
Resting blood pressure
Time frame: 24 weeks
Body fat (Skinfold thickness)
Time frame: 24 weeks
Ventilatory anaerobic threshold (VT)
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2014.
Related trials for Health Status
Active, not recruiting
AI-Supported Mobile High-Impact and Strengthening Exercise Program in Postmenopausal Women With Low Bone Density
Osteopenia
Recruiting
CBCT vs OPT on the Oral Health Status at 12 Months of Patients Hospitalized for Infective Endocarditis.
Infective Endocarditis
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Recruiting
Evaluation of the Impact of the EDIT-B® Blood Test on the Health Status of Patients Presenting a Major Depressive Episode. Clinical Utility and Medico-Economic Aspects
Bipolar Disorder, Major Depressive Disorder
Recruiting
Applying CSNAT in HBPC as an Approach to Elder Mistreatment Risk Reduction
Caregiver Stress, Caregiver Health Related QOL
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Meyer, M.D. Prof. principal investigator
Universität des Saarlandes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Endurance Training in people with Health Status and Maximal and Submaximal Parameters of Physical Performance, run by Universität des Saarlandes at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum oxygen consumption (VO2max) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2014.