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Study stopped due to organization reasons.
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The investigators designed this intervention to investigate the potential role of L-C in lipid and carbohydrates metabolism (primary outcome) with precision noninvasively measurement of: central blood pressure, pulse wave velocity and peripheral arterial stiffness (secondary outcome) in OSA patients.
After screening all patients will be randomized in 1:1 ratio to either placebo group or study group (receiving L-C for 8-weeks). Randomization will stratify patients by: age, sex, BMI and severity of OSA. Randomized patients will receive orally either placebo or L-C once a day for 8-weeks. All supplements will be packed in a white box. Because this is a double-blind study, vial labels will contain a unique identification number that will not disclose to the patient or investigator if L-C or matching placebo is included. The daily amount of L-C will be 1400 mg. The detailed composition of the product will be assessed. All patients will receive a test product during the control visits once a month and will be asked to take it once a day in the morning. The completion of the data will be checked during the visits and also via telephone while the study is conducted. All concomitant medications used (including herbal supplements) will be recorded in electronic database. The patients will be asked to continue their habitual diet. Moreover, they will be also advised that they are free to withdraw from participation in this study at any time, for any reason, and without prejudice. The reason for withdrawal and the date of discontinuation will be recorded in our database. Any Adverse Event (AE) will be recorded according to Common Terminology Criteria for Adverse Events v4.0 (CTCAE), clinically significant AE, severe laboratory abnormality, intercurrent illness, or other medical condition that indicates that continued administration of study medication is not in the best interest of the patient.
The treatment will be administrated under supervision of experienced nutritionist and medical doctor. The anthropometrical and biochemical measurements with assessment of diet, quality of life and sleep will be completed by the patients at each of the study visits, which will take place at the baseline (screening visit), after 4 weeks, in the post-intervention period (week 8) and at a 6-month follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | L-carnitine 1400 mg daily for 8 weeks |
|
| Placebo group | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-carnitine | Dietary Supplement | L-carnitine 1400 mg daily for 8 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Total cholesterol, LDL cholesterol, HDL cholesterol and Triglycerides concentration | 6 months | |
| Changes in fasting glucose concentration | 6 months | |
| Changes in insulin concentration | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in central blood pressure | 6 months | |
| Changes in pulse wave velocity | 6 months | |
| Changes in peripheral arterial stiffness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paweł Bogdański, Ass Prof, MD | Poznan University of Medical Sciences | Principal Investigator |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D002331 | Carnitine |
| ID | Term |
|---|---|
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Placebo |
| Dietary Supplement |
Placebo daily for 8 weeks |
|
| 6 months |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 6 months |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |