None listed
Conditions
Brief summary
Cardiovascular diseases (CVDs) are the leading cause of morbidity and mortality. The importance of CVDs prevention remains undisputed and should be aimed at reducing increased levels of cardiovascular risk factors, such as increased blood lipids, hypertension and endothelial dysfunction. The QHHC-FMD-PILOT study is a double blind, placebo-controlled, Randomized Controlled Trial, aimed to evaluate the impact of a supplementation with Ubiquinol (reduced form of Coenzyme Q10, 200 mg or 100 mg/day) on endothelial function, assessed through a non-invasive ultrasound technique, and oxidative stress in patients with mild-to-moderate dyslipidemia. Given the beneficial antioxidant properties of Coenzyme Q10, we expect that a 8-week supplementation with Ubiquinol could significantly ameliorate endothelial dysfunction and improve selected blood markers of oxidative stress.
Interventions
The study aims to evaluate the impact of a supplementation with ubiquinol (reduced form of ubiquinone or reduced CoQ10) on endothelial function and oxidative stress in patients with mild to moderate dyslipidemia.
During Screening Visit the eligibility criteria will be verified and, if fulfilled, each subject will be randomized to one of the 3 study groups after signing the Informed Consent Form.
At Screening Visit and at Week 4, subjects will receive the assigned test product, according to rando
The study aims to evaluate the impact of a supplementation with ubiquinol (reduced form of ubiquinone or reduced CoQ10) on endothelial function and oxidative stress in patients with mild to moderate dyslipidemia. During Screening Visit the eligibility criteria will be verified and, if fulfilled, each subject will be randomized to one of the 3 study groups after signing the Informed Consent Form. At Screening Visit and at Week 4, subjects will receive the assigned test product, according to randomization, for consumption at home during the coming 4 weeks and leave the facility. The study products include test treatment (ubiquinol, two dosages, 100 and 200 mg daily) and placebo; details on these study products are given in the study products dossiers. Each product (ubiquinol or placebo), have to be taken daily at breakfast and dinner (total two pills: 1 before breakfast and 1 before dinner). The active study products, Ubiquinol-QH 100 mg, will be provided in the form of softgel capsules. Each active softgel capsule contains ubiquinol (Kaneka QH™ active antioxidant form of coenzyme Q10) 100 mg. The product contains also soy and other ingredients: medium chain triglycerides, gelatin, glycerin, ascorbyl palmitate, purified water, beeswax, soy lecithin, annatto extract. Placebo will consist of softgel capsules too, matching the active study products but without any active principle. The subjects will consume 2 softgel capsules per day according to the following scheme: - Group A - Ubiquinol 200mg/day: 2 Ubiquinol-QH 100 mg soft capsules/day - Group B - Ubiquinol 100mg/day: 1 Ubiquinol-QH 100 mg soft capsule and 1 Placebo capsule /day - Group C – Matched placebo: 2 Placebo capsules/day The study products, provided as softgel capsules, will be consumed at home by the subjects, one capsule in the morning and one capsule in the evening, with a meal. Subjects will be instructed to complete a daily diary, in order to evaluate the compliance to both treatment and dietary restrictions. Diary and unopened and empty study products packs will be returned on each follow-up visit and checked by the study personnel as an assessment of compliance. During each visit a short physical examination will be performed and a blood sample (approximately 10 ml) will be collected from the vein in the left arm to evaluate CoQ10 levels and the secondary endpoints. After acclimatisation and rest for at least 30 minutes blood pressure (triplicate, first discarded) and flow-mediated dilation (FMD) (baseline or Week 4 and 8 measurement) will be measured.
Sponsors
I.N.R.C.A. (Italian National Research Centre on Aging)-IRCCS
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
35 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
This study will include male and post-menopausal female subjects. - Male aged 35 - 65 years (35 and 65 included). - Post-menopausal female (without a period for more than 1 year), until 65 years (65 included). - Subjects enrolled for primary prevention but never treated (only life style modification suggested, according guidelines). - FMD level measured between 2,5% and 6% (at Screening Visit). - Body mass index (BMI) between 18.5 and 29.9 kg/m2. - LDL Cholesterol levels between 130 and 200 mg/dl (based on previous evaluation, performed within 1 month from the Screening Visit).
Exclusion criteria
A subject will not be eligible for inclusion in this study if any of the following apply: - Use of any cardiovascular disease related drugs prior to Screening Visit. - Participation in any clinical trial while participating in this trial. - Greater than 5% change in body weight within 1 month of Screening Visit. - Subjects playing competitive physical activity. - Subject taking lipid-altering drug therapy within four weeks prior to Screening Visit. Also excluded are supplements known to have significant lipid altering effects, such as niacin (>100 mg per day), garlic (> 600 mg per day), omega-3 fatty acids (> 1 g omega-3 fatty acids per day), red yeast rice extract, phytostanols / phytosterols (> 0.5 g per day), soluble fiber (>1 g per day), chitosan (> 1 g per day) and conjugated linoleic acid (CLA; > 3 g per day). - Subject taking any concomitant treatment with phosphodiesterase inhibitors (e.g. sildenafil citrate, tadalafil, vardenafil) and donors of NO (nitric oxide), like other long-acting derivatives of GTN (glyceryl trinitrate), such as isosorbide dinitrate and amyl or butyl nitrite. - Excluded concurrent medications are: systemic corticosteroids (nasal and inhaled corticosteroids are permitted), orlistat, bile acid resins, no more than 1 g of prescription omega-3 fatty acids, cyclical or non-continuous hormone therapy (estrogen or testosterone). - No more than 2 alcoholic units per day. Units are defined as 12 grams of ethanol, e.g. a small glass (125 ml) of medium gradation wine, a can of beer (330 ml) of average gradation or 40 ml dose of liquors. - Consumption of flavonoids-enriched products. - Consumption of vitamin C-enriched products or supplements containing vitamin C. - Has a diagnosis of type 1 or type 2 diabetes mellitus, hepatic or renal impairment or diseases, thyroid disorders. - Known cardiovascular disease or stroke, except for conditions that are deemed clinically insignificant by Principle Investigator or Sub-investigator, or study site physician (e.g. clinically insignificant atherosclerotic lesions observed by imaging studies). - History of significant gastrointestinal disease such as severe constipation, diarrhea, malabsorptive disease, inflammatory bowel disease (e.g. Crohn’s disease, ulcerative colitis). - History of severe psychiatric illness which in the opinion of the investigator would interfere with the optimal participation in the study. - History if cancer within 5 years of Screening Visit (except for successfully treated basal and squamous cell carcinoma of the skin). - Known HIV seropositivity. - History of bariatric surgery. - Allergic to the test products or placebo. - Smokers > 10 cigarettes/day. - Individuals who in the opinion of the principal investigator have a risk of non-compliance to the study procedures or who are otherwise not appropriate to include in this clinical trial.
Outcome results
None listed