Healthy VolunteersNCT02635594
Effects of Carnipure® Tartrate on Postprandial Endothelial Function and Recovery
A study testing L-Carnitine in people with Healthy Volunteers and Recovery, run by Lonza Ltd. at 1 site in Germany.
Trial summary
Investigation of 4 weeks supplementation with Carnipure® tartrate on endothelial function and parameters of recovery after physical exertion. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Recovery, Endothelial Function
- What is being tested?
- L-Carnitine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2015to Jun 2016
- 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 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women between 25 and 45 years
- Body mass index (BMI) between 20 and 30 kg/m²
- Non-smoker
- Physically active 1-2 times per week
Who cannot join
- Competitive athlete or performance of high intensity training
- Vegan
- Nutrition with high portion of meat (> 3 times meat per week).
- Injury at the finger
- History or presence of significant cardiovascular disease or co-morbidities (i.e., diabetes, etc.)
- Known allergy to ingredients of study preparation
Show all 21Show fewer
- Disturbed absorption due to changes in the gastrointestinal tract (e.g., resections, diverticula, blind-loop syndrome)
- Hypo/ hypertension or taking anti hypo/ hypertension medication
- Untreated thyroid dysfunction
- Atherosclerosis or other relevant musculoskeletal diseases/ injuries
- Anemia (women: Hb <11 g/ dl; men: 12.5 g/ dl)
- Eating disorder
- Present or recent use of drugs and dietary supplements that affect the endothelial function, re-covery or lipid status 2 months before or during the study (e.g. L-Carnitine, Arginine, omega3 FA, polyphenol rich supplements (e.g. OPC, cacao, etc) antihypertensive drugs, anti hyperlipidemic drugs, regular intake of protein-shakes etc.)
- Subjects not willing to abstain from intake of analgesic medication 24 hours prior to and during visit 1b and 3b.
- Female patients that are pregnant or nursing
- Night shift worker
- Donation of blood or similar blood loss within the previous 30 days before screening;
- Participation in a clinical trial with an investigational product within 30 days before screening
- Known alcohol abuse or drug abuse
- Known infection of human immunodeficiency virus (HIV) or hepatitis B or C
- Known lactose intolerance, dairy protein allergy or allergy to nuts
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Carnipure® Tartrate on Postprandial Endothelial Function and Recovery From Physical Exertion in Healthy People - a Randomized, Double-blind, Placebo-controlled, Two-way Cross-over Study
Investigation of 4 weeks supplementation with Carnipure® tartrate on endothelial function and parameters of recovery after physical exertion.
- Conditions
- Healthy Volunteers, Recovery, Endothelial Function
- Being tested
- L-Carnitine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-CarnitineDietary supplement
1000mg of L-Carnitine provided as 1475mg Carnipure® tartrate
PlaceboOther
1000mg cellulose + 475mg L-tartaric acid
| Study group | Role | What they receive |
|---|---|---|
| Carnipure® tartrate | Experimental | 1000mg of L-Carnitine provided as 1475mg Carnipure® tartrate Receives: Dietary Supplement: L-Carnitine |
| Placebo | Placebo comparator | 1000mg cellulose + 475mg L-tartaric acid Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
postprandial endothelial function
postprandial endothelial function assessed after 4 weeks supplementation with verum in comparison to placebo
Measured: after 4 weeks supplementation
Secondary outcomes (5)
Maximal strength (Nm) before and after exhaustive exercise
Maxiaml strength assessed after 4 weeks supplementation with verum in comparison to placebo at different time points, each (pre exhaustive exercise, immediately after, 2h, 24h and 48h after)
Measured: immediately before, 0h, 2h, 24h, 48h,
pain before and after exhaustive exercise (VAS)
Pain assessed after 4 weeks supplementation with verum in comparison to placebo at different time points, each (pre exhaustive exercise, immediately after, 2h, 24h and 48h after)
Measured: immediately before, 0h, 2h, 24h, 48h,
Creatin Kinase (CK) before and after exhaustive exercise
Assessement of CK after 4 weeks supplementation with verum in comparison to placebo at different time points, each (pre exhaustive exercise, immediately after, 2h, 24h and 48h after)
Measured: immediately before, 0h, 2h, 24h, 48h,
Myoglobine (Mb) before and after exhaustive exercise
Assessement of Mb after 4 weeks supplementation with verum in comparison to placebo at different time points, each (pre exhaustive exercise, immediately after, 2h, 24h and 48h after)
Measured: immediately before, 0h, 2h, 24h, 48h,
Biomarker for vascular health
Biomarker for vascular health assessed after 4 weeks supplementation with verum in comparison to placebo
Measured: after 4 weeks supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lonza Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Menzel, PhD, Principal investigator, BioTeSys GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635594
- Sponsor's protocol ID
- BTS884/15
- Status last verified
- Sep 2016
- First submitted
- 10 Dec 2015
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Carnipure® Tartrate on Postprandial Endothelial Function and Recovery From Physical Exertion in Healthy People - a Randomized, Double-blind, Placebo-controlled, Two-way Cross-over Study
- ClinicalTrials.gov ID
- NCT02635594
- Acronym / sponsor ID
- BTS884/15
- Conditions
- Healthy Volunteers, Recovery, Endothelial Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Lonza Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 21 Dec 2015 (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.
Investigation of 4 weeks supplementation with Carnipure® tartrate on endothelial function and parameters of recovery after physical exertion.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carnipure® tartrate | Experimental | Dietary Supplement: L-Carnitine1000mg of L-Carnitine provided as 1475mg Carnipure® tartrate |
| Placebo | Placebo comparator | Other: Placebo1000mg cellulose + 475mg L-tartaric acid |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy men and women between 25 and 45 years
- Body mass index (BMI) between 20 and 30 kg/m²
- Non-smoker
- Physically active 1-2 times per week
Key exclusion criteria (21 listed)
- Competitive athlete or performance of high intensity training
- Vegan
- Nutrition with high portion of meat (> 3 times meat per week).
- Injury at the finger
- History or presence of significant cardiovascular disease or co-morbidities (i.e., diabetes, etc.)
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 |
|---|---|---|
| L-Carnitine1000mg of L-Carnitine provided as 1475mg Carnipure® tartrate | Dietary supplement | Carnipure® tartrate |
| Placebo1000mg cellulose + 475mg L-tartaric acid | Other | Placebo |
Primary outcome
postprandial endothelial function
Time frame: after 4 weeks supplementation
postprandial endothelial function assessed after 4 weeks supplementation with verum in comparison to placebo
5 secondary outcomes
Maximal strength (Nm) before and after exhaustive exercise
Time frame: immediately before, 0h, 2h, 24h, 48h,
pain before and after exhaustive exercise (VAS)
Time frame: immediately before, 0h, 2h, 24h, 48h,
Creatin Kinase (CK) before and after exhaustive exercise
Time frame: immediately before, 0h, 2h, 24h, 48h,
Myoglobine (Mb) before and after exhaustive exercise
Time frame: immediately before, 0h, 2h, 24h, 48h,
Biomarker for vascular health
Time frame: after 4 weeks supplementation
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 7 Sep 2016.
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Screening Protocol
Pain
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.
Daniel Menzel, PhD principal investigator
BioTeSys GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-Carnitine in people with Healthy Volunteers and Recovery, run by Lonza Ltd. 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 4 inclusion and 21 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 7 Sep 2016. 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.
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?
postprandial endothelial function (time frame: after 4 weeks supplementation). 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 7 Sep 2016.