Study claim: Bitter orange (Citrus aurantium) extract has virtually no impact on blood pressure or heart rate.
Published: Min B, et al. Absence of QTc-interval-prolonging or hemodynamic effects of a single dose of bitter-orange extract in healthy subjects. Pharmaco-therapy 2005 Winter; 25(12): 1719-24.
Abstract: This randomised, double-blind, placebo-controlled, crossover study evaluated the hemodynamic and electrocardiographic effects of a single dose of commercially available bitter orange dried-fruit extract, an ingredient that is increasingly being used in dietary supplements.
Eighteen healthy volunteers aged 18 years or older were given either placebo or bitter orange dried-fruit extract (450mg standardised to 27mg of m- or p-synephrine) in phase 1. The opposite treatment was given during phase 2 after a washout period of at least seven days.
The rate-corrected QT (QTc) interval and blood pressure were measured before dosing and at 1, 3, 5 and 8 hours after dosing. Mean +/- SD values of the maximum postdose values were compared between groups. Subjects receiving bitter-orange extract vs those receiving placebo had similar postdose QTc intervals (402 +/- 29 vs 403 +/- 24 msec), systolic blood pressure (114 +/- 10 vs 115 +/- 8 mm Hg), and diastolic blood pressure (68 +/- 9 vs 68 +/- 8).
Bitter orange dried-fruit extract standardised to m- or p-synephrine 27mg did not significantly alter the QTc interval or blood pressure after a single dose was administered. Future studies are necessary to ensure the safety of this herbal product with multiple doses.
Potential applications: A dietary supplement ingredient for weight loss and sports nutrition.
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Study claim: ForsLean, Sabinsa's patented Coleus forskohlii extract and the only known plant source of forskolin, mitigates weight gain in the overweight.
Published: Henderson S, et al. Effects of Coleus forskohlii supplementation on body composition and hematological profiles in mildly overweight women. J Int Soc Sports Nutr 2005;2(2):54-62.Abstract: Coleus forskohlii (CF) is a botanical that has been used since ancient times in Hindu and Ayurvedic traditional medicine. The root portion of the plant has been traditionally used for medicinal purposes and contains the active constituent forskolin.
This study investigated the effects of CF on body composition, and determined the safety and efficacy of supplementation. In a double-blind and randomised manner, 23 females supplemented their diet with ForsLean (250mg of 10% CF extract, n=7) or a placebo (n=12) two times per day for 12 weeks. Body composition (DEXA), body weight, and psychometric instruments were obtained at 0, 4, 8 and 12 weeks of supplementation. Fasting blood samples and dietary records (4 days) were obtained at 0 and 12 weeks. Side effects were recorded on a weekly basis. Data were analysed by repeated measures and are presented as mean changes from baseline for the CF and placebo groups, respectively.
No significant differences were observed in caloric or macronutrient intake. CF tended to mitigate gains in body mass (-0.7?1.8, 1.0?2.5kg) and scanned mass (-0.2?1.3, 1.7?2.9kg) with no significant differences in fat mass (-0.2?0.7, 1.1?2.3kg), fat-free mass (-0.1?1.3, 0.6?1.2 kg), or body fat (-0.2?1.0, 0.4?1.4%). Subjects in the CF group tended to report less fatigue, hunger and fullness. No clinically significant interactions were seen in metabolic markers, blood lipids, muscle and liver enzymes, electrolytes, red cells, white cells, hormones (insulin, TSH, T3, and T4), heart rate, blood pressure, or weekly reports of side effects.
Potential applications: ForsLean does not appear to promote weight loss but may help mitigate weight gain in overweight females with apparently no clinically significant side effects.
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