A polyphenol fraction from Rosa multiflora var. platyphylala reduces body fat in overweight humans through appetite suppression - a randomized, double-blind, placebo-controlled trial.

BACKGROUND: Rosa species are rich sources of polyphenols with physiological functions. In this study a polyphenol-rich Rosa multiflora (var. platyphylala) petal extract (RoseFit™) was investigated for weight loss in humans. METHODS: In a randomized, placebo-controlled, parallel-group, double-blind clinical trial seventy overweight male and female subjects (20-50 years) with body mass index (BMI) 25-30 kg/m2 were randomly allocated to the active treatment group (RoseFit) and placebo group in a 1:1 ratio. The subjects received 300 mg capsules twice daily for 12 weeks. The primary efficacy outcome measures included body weight, BMI, and body composition, as determined using Dual-energy X-ray absorptiometry (DEXA). Secondary measures consisted of serum lipid profile and appetite marker (leptin and ghrelin) analyses. Safety analyses included biochemical and hematological assessments. RESULTS: At the end of the study, a marked reduction in body weight (-1.20 ± 2.62 kg, p < 0.05) and BMI from baseline was observed in the RoseFit group. In addition, the body fat % (RoseFit = -1.69 ± 2.59%, placebo = 0.96 ± 3.21%; p < 0.001) and fat mass (RoseFit = -1.75 ± 1.80 kg, placebo = 1.61 ± 3.82 kg; p < 0.001) were significantly abated in RoseFit group. Importantly, the lean mass was maintained during the intervention. RoseFit ingestion significantly increased the serum leptin levels compared to the placebo (4.85%; p < 0.05). Further, RoseFit group showed reduction in the hunger hormone ghrelin level (2.27%; p < 0.001) from baseline to the end of study, compared to the placebo. The subjective evaluation of appetite using visual analog scale (VAS) questionnaires further confirmed the appetite-suppression effects of RoseFit. The lipid profile significantly improved in RoseFit-treated subjects. No serious adverse events were observed during the study, indicating the tolerability of RoseFit. CONCLUSIONS: Supplementation with RoseFit significantly impacts body weight management and can thus be a potential nutraceutical ingredient for sustainable weight loss. TRIAL REGISTRATION: CTRI/2019/10/021584 dated 09/10/2019.

Oral and Topical Administration of a Standardized Saw Palmetto Oil Reduces Hair Fall and Improves the Hair Growth in Androgenetic Alopecia Subjects - A 16-Week Randomized, Placebo-Controlled Study.

Purpose: Androgenetic alopecia (AGA) is the most common type of hair loss in humans, affecting self-esteem and emotional well-being. This study aimed to assess the safety and efficacy of VISPOTM, a standardized saw palmetto oil (2-3% ß-sitosterol), in subjects with mild-to-moderate AGA. Methods: In a double-blind, placebo-controlled, four-arm clinical study, 80 healthy male and female subjects aged 18-50 years were randomly allocated (1:1:1:1) to receive either 400 mg capsules of VISPO or 5 mL of a topical formulation containing 20% VISPO or the respective placebo once daily for 16 weeks. The primary endpoints included hair count (hair comb and hair pull tests) and the self-assessment of perceived efficacy. Objective evaluation was performed using the global photographic assessment score. Hair density, thickness, and anagen/telogen ratio were evaluated using phototrichogram analysis. Results: At the end of the study, oral and topical formulations of VISPO reduced hair fall by up to 29% (p<0.001) and 22.19% (p<0.01) from the baseline, respectively. Hair density increased by 5.17% and 7.61% in the oral and topical VISPO groups, respectively (p<0.001). In addition, oral ingestion of VISPO resulted in a marked reduction in serum dihydrotestosterone (DHT) levels in the subjects compared to placebo (p<0.001). However, the effect of the VISPO formulations on the anagen/telogen ratio was insignificant. No serious adverse effects were observed during the study. Conclusion: VISPO formulations reduced hair fall and promoted hair regrowth and scalp appearance in AGA patients.

Aframomum melegueta Seed Extract with Standardized Content of 6-Paradol Reduces Visceral Fat and Enhances Energy Expenditure in Overweight Adults - A Randomized Double-Blind, Placebo-Controlled Clinical Study.

Purpose: Aframomum melegueta (grains of paradise) seeds have been demonstrated to possess thermogenic potential. However, it is necessary to validate the functional attributes of A. melegueta seed extract in human subjects. Methods: In a double-blind, placebo-controlled clinical trial design, we have examined the thermogenic effects of a standardized A. melegueta seed extract (AfperFit). A total of 70 overweight male and female subjects (BMI ≥25.0 to ≤30.0 kg/m2) aged 20-50 years were enrolled and administered with either 250 mg of AfperFit or placebo in capsule form twice daily for 12 weeks. The primary efficacy endpoints included energy expenditure (indirect calorimetry), body composition (dual-energy X-ray absorptiometry (DEXA)) and fat distribution (computed tomography (CT scan)), analyzed at baseline and after 12 weeks of treatment. The effect of intervention on the quality of life was examined using SF-12 questionnaire. Results: Consumption of AfperFit significantly increased the energy expenditure (p<0.01), visceral fat area (p<0.001) and visceral to subcutaneous fat ratio (p<0.01) compared to placebo group. Consequently, there was significant body weight loss and reduction in BMI of subjects in AfperFit group compared to placebo (p<0.01). The safety evaluation showed that biochemical and hematological parameters were in the normal range. Supplementation of AfperFit was well tolerated during the study and no adverse effects were observed. Conclusion: Overall, this study validates the health benefits of A. melegueta seed extract as fat burner and recommends its use as a functional ingredient to improve the quality of life and general health.