Nutrition ProcessesNCT00799630
Effects of Nutraperf Consumption in Runners
A study testing Carbohydrate drink in people with Nutrition Processes, run by Lescuyer Laboratory at 1 site in France.
Trial summary
Exercise has numerous health benefits. Nevertheless, when exercise duration is ~45 min or longer and intensity moderate to intense, it may induce different troubles, for example: hypoglycemia, peripheral and central fatigue, muscle damages, osteoarticular injuries, inflammation, cardiovascular dysfunctions. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Nutrition Processes
- What is being tested?
- Carbohydrate drink
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2008to not given
- Phase
- Interventional
- 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Man aged between 18 and 45 years.
- Regular sportsman (2 to 4 workouts by week since 3 months minimum).
- Be a long-distance runner.
- Be affiliated or beneficial to the National French Security Social.
- Non-inclusion criteria
- Any subject who was injured during the three preceding months study.
- Any subject with a history of disease can disrupt the tests. In particular, subjects with pathological conditions placed on the joints of the knee or ankle (sprain repeated problems or patellar ligament) that could hamper measures of force maximum extension and flexion on these joints or illnesses that prevent the exercise of pedalling or running on treadmill (tendonitis, periostitis) will be excluded.
- Any subject who at the same time participates at another medical experiment.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Physiologie Clinique et de l'Exercice, CHU Saint-Etienne
Saint-Etienne, 42055
About this study
Official title: Identification of the Effects of NUTRAPERF Consumption on Performance in Endurance-Type Exercise.
Exercise has numerous health benefits. Nevertheless, when exercise duration is ~45 min or longer and intensity moderate to intense, it may induce different troubles, for example: hypoglycemia, peripheral and central fatigue, muscle damages, osteoarticular injuries, inflammation, cardiovascular dysfunctions. Nutritional loading during exercise may prevent and and/or reduce some of these troubles.
In regard of recent data, we proposed a novel energy drink (NUTRAPERF®) to limit deleterious effects of long time exercise in neutral environment (outside temperature between 4 and 25°C) and to improve performance. If performance may be increased by this energy drink during long time exercise, we proposed that it consumption may also improve performance in short and sub-maximal exercise.
So, the purpose of this study is to investigate the effects of the consumption of this novel energy drink on performance during long and short time exercise. Moreover, we studied the effects of this consumption on different metabolic parameters (heart rate, oxygen consumption, respiratory quotient, ventilation, glycemia, lactatemia), on central and peripheral fatigue and on cognitive parameters.
- Conditions
- Nutrition Processes
- Being tested
- Carbohydrate drink
- Keywords
- energy drink, exercise, BCAA, peripheral and central fatigue
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate drinkDietary supplement
Also called NUTRAPERF
Maltodextrins, dextrose, fructose, amino acids (leucine, isoleucine, valine), natural flavors, sodium chloride, magnesium citrate, zinc, lactate, acid: malic acid, anti-caking agent: silicon dioxide; Curcumin (turmeric extract) , Thickener: xanthan gum, caffeine, vitamin C (Acerola extract), vitamin E - B1 - B2 - B3; piperine (black pepper extract).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2008 (estimated)
- Study startNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nutrition ProcessesStudies 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
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lescuyer Laboratory
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre Hospitalier Universitaire de Saint Etienne, Université Savoie Mont Blanc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00799630
- Sponsor's protocol ID
- 2008-A00982-53
- Status last verified
- Nov 2008
- First submitted
- 7 Nov 2008
- Last updated
- 1 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Peltier SL, Vincent L, Millet GY, Sirvent P, Morin JB, Guerraz M, Geyssant A, Lescuyer JF, Feasson L, Messonnier L. Effects of carbohydrates-BCAAs-caffeine ingestion on performance and neuromuscular function during a 2-h treadmill run: a randomized, double-blind, cross-over placebo-controlled study. J Int Soc Sports Nutr. 2011 Dec 7;8:22. doi: 10.1186/1550-2783-8-22.
PubMed 22152427
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of the Effects of NUTRAPERF Consumption on Performance in Endurance-Type Exercise.
- ClinicalTrials.gov ID
- NCT00799630
- Acronym / sponsor ID
- 2008-A00982-53
- Conditions
- Nutrition Processes
- Keywords
- energy drink, exercise, BCAA, peripheral and central fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Lescuyer LaboratoryIndustry (pharma, biotech, devices)
- Collaborators
- Centre Hospitalier Universitaire de Saint Etienne, Université Savoie Mont Blanc
- Study start
- Nov 2008
- First posted
- 1 Dec 2008 (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.
Exercise has numerous health benefits. Nevertheless, when exercise duration is ~45 min or longer and intensity moderate to intense, it may induce different troubles, for example: hypoglycemia, peripheral and central fatigue, muscle damages, osteoarticular injuries, inflammation, cardiovascular dysfunctions. Nutritional loading during exercise may prevent and and/or reduce some of these troubles.
In regard of recent data, we proposed a novel energy drink (NUTRAPERF®) to limit deleterious effects of long time exercise in neutral environment (outside temperature between 4 and 25°C) and to improve performance. If performance may be increased by this energy drink during long time exercise, we proposed that it consumption may also improve performance in short and sub-maximal exercise.
So, the purpose of this study is to investigate the effects of the consumption of this novel energy drink on performance during long and short time exercise. Moreover, we studied the effects of this consumption on different metabolic parameters (heart rate, oxygen consumption, respiratory quotient, ventilation, glycemia, lactatemia), on central and peripheral fatigue and on cognitive parameters.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Man aged between 18 and 45 years.
- Regular sportsman (2 to 4 workouts by week since 3 months minimum).
- Be a long-distance runner.
- Be affiliated or beneficial to the National French Security Social.
- Non-inclusion criteria
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 |
|---|---|---|
| Carbohydrate drinkAlso: NUTRAPERFMaltodextrins, dextrose, fructose, amino acids (leucine, isoleucine, valine), natural flavors, sodium chloride, magnesium citrate, zinc, lactate, acid: malic acid, anti-caking agent: silicon dioxide; Curcumin (turmeric extract) , Thickener: xanthan gum, caffeine, vitamin C (Acerola extract), vitamin E - B1 - B2 - B3; piperine (black pepper extract). | Dietary supplement | – |
Primary outcome
Not reported in the source record.
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 1 Dec 2008.
- Derived from this study: PubMed 22152427Peltier SL, Vincent L, Millet GY, Sirvent P, Morin JB, Guerraz M, Geyssant A, Lescuyer JF, Feasson L, Messonnier L. Effects of carbohydrates-BCAAs-caffeine ingestion on performance and neuromuscular function during a 2-h treadmill run: a randomized, double-blind, cross-over placebo-controlled study. J Int Soc Sports Nutr. 2011 Dec 7;8:22. doi: 10.1186/1550-2783-8-22.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrate drink in people with Nutrition Processes, run by Lescuyer Laboratory at 1 site in France.
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 8 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 1 Dec 2008. 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 France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00799630, which also lists 1 linked publication.
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 1 Dec 2008.