Coenzyme Q10 (CoQ10) - Clinical Trials
|I Product Info||I Ingredients||I Recommended Use||I Clinical Trials||I Research Brief||I References|
Indication: cardiovascular disease prophylaxis, coronary circulation impairment, insufficient cardiac muscle nourishment, high blood pressure, muscle weakness, impaired metabolism, intensive sports training, physical overload.
Main Actions: heart muscle energizer, essential for healthy cardiovascular system, improves host defenses, strengthens cell membranes, maintains healthy gums, potent antioxidant.
Ingredients (per 1 gelcap):
Coenzyme Q10 (Ubidecarenone) – 50 мg, Conjugated Linolic Acid (CLA) – 400 mg, Flaxseed Oil (55% ALA (alpha linolic acid)) – 200 mg
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Coenzyme Q10 (CoQ10) Clinical Trials:
Numerous clinical trials have provided evidence, supporting the use of CoQ10 in the prevention and treatment of various disorders related to oxidative stress.
A multicenter, randomized, double-blind, placebo-controlled study by Morisco et al. evaluated the effect of CoQ10 in patients with NYHA Class III and IV HF receiving conventional treatment for heart failure. All enrolled patients had symptoms of dyspnea and/or fatigue with signs of fluid retention and no evidence of pulmonary disease. Subjects were randomized to receive adjunctive therapy of either placebo (n=322) or CoQ10 2 mg/kg/day (n=319) up to a maximum daily dose of 150 mg for one year. Assessment parameters at 3, 6, and 12 months included the incidence of hospitalization, pulmonary edema, cardiac asthma, ventricular arrhythmias, or mortality. Conventional drug regimens, adjusted to maintain hemodynamic stability, and patient demographics were similar in both groups. The incidence of one or more hospitalizations for symptomatic CHF in both the CoQ10 and placebo groups were 20% and 40% (p<0.01), respectively. The number of deaths in each group was not statistically significant. The authors concluded that the incidence of pulmonary edema, cardiac asthma, and arrhythmia was significantly lower in the CoQ10 group vs. the placebo group and that treating 1000 patients for one year with study doses of CoQ10 may prevent 200 hospitalizations due to worsening CHF symptoms. (3)
Baggio et al. (1994) studied the efficacy of CoQ10 as adjunctive therapy in an open, prospective, noncomparative, multicenter study of 2,359 evaluable patients with heart failure in NYHA Class II (n=1,715) or III (n=644) stabilized on conventional therapy. Patients received 50–150 mg/day of CoQ10. At the end of the three-month study period, the proportions of patients with improvements in clinical and functional assessment from baseline were documented. The results indicated improvements in cyanosis (78.1%), edema (78.6%), pulmonary rales (77.8%), hepatomegaly (49.3%), jugular reflux (71.8%), dyspnea (52.7%), palpitations (75.4%), sweating (79.8%), vertigo (73.1%), subjective arrhythmia (63.4%), insomnia (62.8%) and nocturia (53.6%). Fifty-four percent of patients had improvements of at least three symptoms. Moreover, 28.8% of patients entered as NYHA Class III improved in score to Class II and 89.7% of patients entered as NYHA Class II improved in score to Class I. The authors concluded that patients receiving CoQ10 improved functionally and that patients in NYHA Class II showed better improvement rates than did patients in NYHA Class III. (4)
In a double-blind, randomized, placebo-controlled crossover trial of 12 adults with stable angina on conventional therapy, supplements of 150 mg/day of CoQ10 for four weeks showed a decrease in both anginal frequency and use of nitroglycerin (p>0.05). (5)
Increasing numbers of the adult population are using alternative or complementary health resources in the treatment of chronic medical conditions. Systemic hypertension affects more than 50 million adults and is one of the most common risk factors for cardiovascular morbidity and mortality. This study evaluates the antihypertensive effectiveness of oral coenzyme Q10 (CoQ), an over-the-counter nutritional supplement, in a cohort of 46 men and 37 women with isolated systolic hypertension. METHODS: We conducted a 12-week randomized, double-blind, placebo-controlled trial with twice daily administration of 60 mg of oral CoQ and determination of plasma CoQ levels before and after the 12 weeks of treatment. RESULTS: The mean reduction in systolic blood pressure of the CoQ-treated group was 17.8 +/- 7.3 mm Hg (mean +/- SEM). None of the patients exhibited orthostatic blood pressure changes. CONCLUSIONS: Our results suggest CoQ may be safely offered to hypertensive patients as an alternative treatment option. (6)
In a randomized, double-blind trial of hypertensive patients with coronary artery disease (CAD) (1999), the effects on blood pressure and insulin resistance of CoQ10 (60 mg twice daily) was compared to vitamin B complex. After an eight-week period, reductions were reported in the following indices: systolic and diastolic blood pressure; lipid peroxidase; fasting and 2-hour plasma insulin; blood glucose; and serum triglyceride levels. Moreover, an increase in high density lipoprotein (HDL)-cholesterol and vitamins A, C, and E, and beta carotene serum concentrations in the CoQ10 treated group were observed. However, an increase in vitamin C and beta carotene serum concentrations were the only changes seen in the vitamin B complex group. (7)
Coenzyme Q10 improves blood pressure and glycaemic control: a controlled trial in subjects with type 2 diabetes by Hodgson J.M. and co-authors (2002). The objective was to assess effects of dietary supplementation with coenzyme Q10 (CoQ) on blood pressure and glycaemic control in subjects with type 2 diabetes, and to consider oxidative stress as a potential mechanism for any effects.
Seventy-four subjects with uncomplicated type 2 diabetes and dyslipidaemia were involved in a randomised double blind placebo-controlled 2x2 factorial intervention.
The study was performed at the University of Western Australia, Department of Medicine at Royal Perth Hospital, Australia.
Subjects were randomly assigned to receive an oral dose of 100 mg CoQ twice daily (200 mg/day), 200 mg fenofibrate each morning, both or neither for 12 weeks.
Fenofibrate did not alter blood pressure, HbA(1c), or plasma F2-isoprostanes. There was a 3-fold increase in plasma CoQ concentration (3.4+/-0.3 micro mol/l, P<0.001) as a result of CoQ supplementation. The main effect of CoQ was to significantly decrease systolic (-6.1+/-2.6 mmHg, P=0.021) and diastolic (-2.9+/-1.4 mmHg, P=0.048) blood pressure and HbA(1c) (-0.37+/-0.17%, P=0.032). Plasma F2-isoprostane concentrations were not altered by CoQ (0.14+/-0.15 nmol/l, P=0.345).
These results show that CoQ supplementation may improve blood pressure and long-term glycaemic control in subjects with type 2 diabetes. (8)
Decreased serum and gingiva levels of CoQ10 have been documented in patients with periodontal disease. In fact, a small double-blind placebo-controlled trial conducted by Wilkinson et al. found CoQ10 50 mg/day for 21 days to significantly improve several clinical aspects of periodontal disease, including inflammation, pocket depth, and tooth mobility. (9)
Studies have demonstrated that the degree of CoQ10 deficiency is correlated with the severity of immune compromised diseases. A clinical case series of eight adult patients treated with 60 mg/day of CoQ10 reported significant increases in serum IgG levels over 1–4 months. (10)
An open, non-comparative pilot study of 14 healthy adults treated with 100 mg/day of CoQ10 for two months showed significant increases in T4/T8 ratios, indicating stimulation of the immune system. (11)