Fatigue; Muscle, HeartNCT04885010
Probiotics and Overreaching Recovery
A study testing probiotics in people with Fatigue; Muscle, Heart and Immunosuppression, run by University of Padova.
Trial summary
Overloading is a key training principle used by athletes and coaches to improve physical performance. Intensified training periods are therefore commonly incorporated into the course of a regular training season. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatigue; Muscle, Heart, Immunosuppression
- What is being tested?
- probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 31 Dec 2021
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 25-55 years
- Body mass index:> 18 and <30 kg / m2
- Stable body weight for at least 3 months
- regular practice of physical activity for at least 2 years
Who cannot join
- Chronic diseases (cardiovascular, hepatic, respiratory, cancer)
- Acute inflammatory states, infections or other pathologies
- Regular use of probiotics
- Use or treatment with steroids (within the previous 3 months)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Probiotics for Athlete's Recovery and Immune System
Overloading is a key training principle used by athletes and coaches to improve physical performance. Intensified training periods are therefore commonly incorporated into the course of a regular training season. From a clinical point of view, very intense periods of training are associated with a temporary immunological deficiency which can lead to teh "overreaching syndroms".
During periods of overreaching, nutritional strategies are mainly aimed at ensuring sufficient amounts of energy to support the increase in effort. However less is known about nutritional supplements to attenuated the inflammatory/immunological response to training stress.
Probiotic bacteria are defined as live food ingredients beneficial to the host's health. Numerous health benefits have been attributed to probiotics, including effects on gastrointestinal tract function and disease, immune function, hyperlipidemia, hypertension, and allergic conditions. Studies in the literature on the ergogenic effect of probiotics in athletes are still scarce today. this study aims to explore the potential role of probiotics on performance, recovery from fatigue and immune function during intensive period of training.
- Conditions
- Fatigue; Muscle, Heart, Immunosuppression
- Being tested
- probiotics, placebo
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probioticsDietary supplement
participants will be given probiotics twice a day for 15 days
placeboDietary supplement
participants will be given a placebo twice a day for 15 days
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Experimental | participants will train for 15 days while consuming the dietary supplement. During the last 8 days the intensity of training will increase to induce overreaching. Receives: Dietary Supplement: probiotics |
| Placebo | Placebo comparator | participants will train for 15 days while consuming the dietary supplement. During the last 8 days the intensity of training will increase to induce overreaching. Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
lymphocyte subpopulation total T (CD3+)
lymphocyte subpopulation: total T (CD3+) %
Measured: Change from baseline to up to 15 days
T-helper (CD4+)
lymphocyte subpopulation: T-helper (CD4+) %
Measured: Change from baseline to up to 15 days
T-suppressor (CD8+)
lymphocyte subpopulation: T-suppressor (CD8+) %
Measured: Change from baseline to up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start1 Jun 2021 (estimated)
- Primary completion30 Sep 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatigue; Muscle, HeartStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885010
- Sponsor's protocol ID
- PARIS
- Status last verified
- May 2021
- First submitted
- 7 May 2021
- Last updated
- 13 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics for Athlete's Recovery and Immune System
- ClinicalTrials.gov ID
- NCT04885010
- Acronym / sponsor ID
- PARIS
- Conditions
- Fatigue; Muscle, Heart, Immunosuppression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 13 May 2021 (actual)
- 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.
Overloading is a key training principle used by athletes and coaches to improve physical performance. Intensified training periods are therefore commonly incorporated into the course of a regular training season. From a clinical point of view, very intense periods of training are associated with a temporary immunological deficiency which can lead to teh "overreaching syndroms".
During periods of overreaching, nutritional strategies are mainly aimed at ensuring sufficient amounts of energy to support the increase in effort. However less is known about nutritional supplements to attenuated the inflammatory/immunological response to training stress.
Probiotic bacteria are defined as live food ingredients beneficial to the host's health. Numerous health benefits have been attributed to probiotics, including effects on gastrointestinal tract function and disease, immune function, hyperlipidemia, hypertension, and allergic conditions. Studies in the literature on the ergogenic effect of probiotics in athletes are still scarce today. this study aims to explore the potential role of probiotics on performance, recovery from fatigue and immune function during intensive period of training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Experimental | Dietary Supplement: probioticsparticipants will train for 15 days while consuming the dietary supplement. During the last 8 days the intensity of training will increase to induce overreaching. |
| Placebo | Placebo comparator | Dietary Supplement: placeboparticipants will train for 15 days while consuming the dietary supplement. During the last 8 days the intensity of training will increase to induce overreaching. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age 25-55 years
- Body mass index:> 18 and <30 kg / m2
- Stable body weight for at least 3 months
- regular practice of physical activity for at least 2 years
Key exclusion criteria (4 listed)
- Chronic diseases (cardiovascular, hepatic, respiratory, cancer)
- Acute inflammatory states, infections or other pathologies
- Regular use of probiotics
- Use or treatment with steroids (within the previous 3 months)
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 |
|---|---|---|
| probioticsparticipants will be given probiotics twice a day for 15 days | Dietary supplement | Probiotics |
| placeboparticipants will be given a placebo twice a day for 15 days | Dietary supplement | Placebo |
Primary outcome
lymphocyte subpopulation total T (CD3+)
Time frame: Change from baseline to up to 15 days
lymphocyte subpopulation: total T (CD3+) %
T-helper (CD4+)
Time frame: Change from baseline to up to 15 days
lymphocyte subpopulation: T-helper (CD4+) %
T-suppressor (CD8+)
Time frame: Change from baseline to up to 15 days
lymphocyte subpopulation: T-suppressor (CD8+) %
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing probiotics in people with Fatigue; Muscle, Heart and Immunosuppression, run by University of Padova.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tatiana Moro, PhD (0498275306, tatiana.moro@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lymphocyte subpopulation total T (CD3+) (time frame: Change from baseline to up to 15 days). The study lists 3 primary outcomes in all. 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 13 May 2021.