Reconstitution After Bicycle InterventionNCT03136133
Protein Supplements to Cyclists
A study testing Active protein drink in people with Reconstitution After Bicycle Intervention, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
To investigate the effect of marine peptide combined with dietary protein on the capacity to recover after exhaustive endurance cycling as measured by exercise capacity and blood glucose homeostasis. Read more about this study
- Who is it for?
- Ages 40 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Reconstitution After Bicycle Intervention
- What is being tested?
- Active protein drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteNorway
- Study dates
- 14 Sep 2017to 31 Dec 2018
- 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 40 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed Consent
- The subject is a man between 40-50 years
- The subject has a body mass index (BMI) between 19-29
- Willing to comply with all study procedures and be available for the length of the study
- In good general health as judged by the physician at the screening visit
Who cannot join
- The subject has had surgery or trauma with significant blood loss or has donated blood within the last 3 months prior to the screening visit
- Diabetes type 1 or 2, or persistent high blood sugar levels
- The subject has tested positive for human immunodeficiency virus (HIV)
- Hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV)
- The subject has taken any investigational drugs within 1 month prior to screening
- Treated with antibiotics within 3 months prior to screening (oral, parenteral or rectal), but not spray or ointment
- Treated with steroids within 1 month prior to screening (including oral treatment)
- Treated with medication that effects the intestinal function such as, H2- protonpump inhibitors, diuretics, antiemetics, antidepressants, antacids,
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Haukeland University Hospital
Bergen, 5021
Trygve Hausken, MD
About this study
Official title: Effekt of Marine Peptide Supplementation on Recovery Following Endurance Cycling
To investigate the effect of marine peptide combined with dietary protein on the capacity to recover after exhaustive endurance cycling as measured by exercise capacity and blood glucose homeostasis.
Read the detailed description
The current study uses cyclists as test subjects since they represent a physical demanding sport requiring both high endurance capacity and muscle strength. In the recovery phase following exhaustive physical activity there is a need both for rebuilding the muscle energy stores, for muscle repair and for compensatory muscle cell development. Therefore, marine peptide combined with dietary protein will be given in order to examine the capacity to recover after exhaustive endurance cycling.
- Being tested
- Active protein drink
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active protein drinkDietary supplement
Fish protein from cod to be used for man after Heavy excercise to restitute
| Study group | Role | What they receive |
|---|---|---|
| Active protein drink | Active comparator | Active protein drink Receives: Dietary Supplement: Active protein drink |
| Placebo drink | Placebo comparator | Placebo drink Receives: Dietary Supplement: Active protein drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood glucose compared to placebo
Measured: Change from baseline to every 30 minutes after dosing, for 2 hours
Secondary outcomes (1)
Change in insulin-like peptide 5 compared to placebo
Measured: Change from baseline to every 30 minutes after dosing, for 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start14 Sep 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
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 Reconstitution After Bicycle InterventionStudies 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
- Crossover
- Model description
- Crossover, placebo controlled
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Firmenich Bjørge Biomarine As
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136133
- Sponsor's protocol ID
- 2017/56
- Status last verified
- Sep 2017
- First submitted
- 27 Apr 2017
- Last updated
- 15 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mjos I, Thorsen E, Hausken T, Lied E, Nilsen RM, Bronstad I, Edvardsen E, Frisk B. The effect of low dose marine protein hydrolysates on short-term recovery after high intensity performance cycling: a double-blinded crossover study. J Int Soc Sports Nutr. 2019 Oct 29;16(1):48. doi: 10.1186/s12970-019-0318-3.
PubMed 31665070
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effekt of Marine Peptide Supplementation on Recovery Following Endurance Cycling
- ClinicalTrials.gov ID
- NCT03136133
- Acronym / sponsor ID
- 2017/56
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Firmenich Bjørge Biomarine As
- Study start
- 14 Sep 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 2 May 2017 (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.
To investigate the effect of marine peptide combined with dietary protein on the capacity to recover after exhaustive endurance cycling as measured by exercise capacity and blood glucose homeostasis.
Detailed description
The current study uses cyclists as test subjects since they represent a physical demanding sport requiring both high endurance capacity and muscle strength. In the recovery phase following exhaustive physical activity there is a need both for rebuilding the muscle energy stores, for muscle repair and for compensatory muscle cell development. Therefore, marine peptide combined with dietary protein will be given in order to examine the capacity to recover after exhaustive endurance cycling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Crossover, placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Active protein drink | Active comparator | Dietary Supplement: Active protein drinkActive protein drink |
| Placebo drink | Placebo comparator | Dietary Supplement: Active protein drinkPlacebo drink |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Signed informed Consent
- The subject is a man between 40-50 years
- The subject has a body mass index (BMI) between 19-29
- Willing to comply with all study procedures and be available for the length of the study
- In good general health as judged by the physician at the screening visit
Key exclusion criteria (8 listed)
- The subject has had surgery or trauma with significant blood loss or has donated blood within the last 3 months prior to the screening visit
- Diabetes type 1 or 2, or persistent high blood sugar levels
- The subject has tested positive for human immunodeficiency virus (HIV)
- Hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV)
- The subject has taken any investigational drugs within 1 month prior to screening
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 |
|---|---|---|
| Active protein drinkFish protein from cod to be used for man after Heavy excercise to restitute | Dietary supplement | Active protein drink, Placebo drink |
Primary outcome
Change in blood glucose compared to placebo
Time frame: Change from baseline to every 30 minutes after dosing, for 2 hours
1 secondary outcome
Change in insulin-like peptide 5 compared to placebo
Time frame: Change from baseline to every 30 minutes after dosing, for 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
- Derived from this study: PubMed 31665070Mjos I, Thorsen E, Hausken T, Lied E, Nilsen RM, Bronstad I, Edvardsen E, Frisk B. The effect of low dose marine protein hydrolysates on short-term recovery after high intensity performance cycling: a double-blinded crossover study. J Int Soc Sports Nutr. 2019 Oct 29;16(1):48. doi: 10.1186/s12970-019-0318-3.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active protein drink in people with Reconstitution After Bicycle Intervention, run by Haukeland University Hospital at 1 site in Norway.
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 5 inclusion and 8 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 15 Sep 2017. 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 Norway. 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.
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 Trygve Hausken, MD (+4755972134, trygve.hausken@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood glucose compared to placebo (time frame: Change from baseline to every 30 minutes after dosing, for 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03136133, 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 15 Sep 2017.