Abstract
BackgroundThe objective of this clinical study was to assess the potential benefit of a dietary supplement, NP 06-1, on cardiovascular protective properties in overweight and normal weight adults diagnosed with osteoarthritis of the knee.MethodsAn 8-week, placebo-controlled, randomized, double-blind study was conducted with four groups, comparing the effects of NP 06-1 to placebo in overweight and normal weight subjects diagnosed with primary osteoarthritis of the knee. NP 06-1 (a combination of two botanical extracts; Phellodendron amurense bark and Citrus sinensis peel) or matching placebo was given in a dose of two capsules (370 mg each) twice daily. The outcome measures reported are lipid levels, weight, BMI, blood pressure and fasting glucose. Analyses of variance were used to compare changes of physiological measures over the trial period and between groups.ResultsEighty (80) subjects were enrolled and 45 subjects completed the study. No serious adverse events were reported. NP 06-1 administration was associated with a general improvement in lipid levels. Both the overweight and normal weight treatment groups had significant reductions in triglycerides and LDL-cholesterol, as well as a significant increase in HDL-cholesterol compared to their respective control groups.Overall there were decreases in blood pressure in both overweight and normal weight treatment groups compared to respective placebo groups. There was also a significant decrease in fasting glucose levels in the overweight treatment group compared to the start of the study and to the overweight placebo group. There was no change in fasting blood sugar for the normal weight groups.Both overweight and normal weight treatment groups lost a significant amount of weight compared to their respective placebo groups. The overweight treatment group lost an average of 5% body weight after 8 weeks, which was associated with a significant loss in BMI over time.ConclusionIn this pilot study NP 06-1 had a beneficial effect on cardiovascular risk factors; namely lipid levels, blood pressure and fasting glucose levels. Administration of NP 06-1 was also associated with weight loss.
Highlights
The objective of this clinical study was to assess the potential benefit of a dietary supplement, normal-weight placebo groups (NP) 06-1, on cardiovascular protective properties in overweight and normal weight adults diagnosed with osteoarthritis of the knee
In this pilot study NP 06-1 had a beneficial effect on cardiovascular risk factors; namely lipid levels, blood pressure and fasting glucose levels
Eighty (80) subjects were enrolled in the study and randomized into four groups designated overweight placebo (OP) (Overweight Placebo), overweight treatment (OT) (Overweight Treatment), NP (Normal weight Placebo) and normal-weight treatment (NT) (Normal weight Treatment) (Table 1)
Summary
The objective of this clinical study was to assess the potential benefit of a dietary supplement, NP 06-1, on cardiovascular protective properties in overweight and normal weight adults diagnosed with osteoarthritis of the knee. Osteoarthritis, the most common form of arthritis, is characterized by degradation of articular cartilage which manifests as joint pain followed by reduced mobility. Therapies for osteoarthritis include weight control, physiotherapy and pharmacological agents. Conventional drug treatments include analgesics, anti-inflammatory agents, disease modifying therapies, hyaluronic acid, intra-articular glucocorticoids and topical analgesic/anti-inflammatory agents [1]. More recently there has been a focus on nutritional support. Recent systematic reviews highlight the scientific evidence for potential nutritional and herbal preparations for those with osteoarthritis [2,3]
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