Discussion
Obesity, obesity, stroke, CVD, overweight, weight loss
OBESITY, ADVERSE REACTIONS, OBESITY, OBESE, CVD, STROKE, CHRONIC DISEASES, BLIND, TYPE 2 DIABETES
We performed a 16-week, randomized, double-blind, placebo-controlled clinical trial to evaluate the anti-obesity efficacy and safety of NAOs in overweight and obese subjects. After 16 weeks of intake, VFA and VSR were significantly reduced in the NAOs group, and weight and BMI were significantly suppressed from increase compared to the placebo group. HDL-C showed a tendency to increase significantly in the NAOs group compared to the placebo group.Obesity is defined as an excess of body fat [BMI has long been recognized as a predictor of morbidity and mortality from numerous chronic diseases, including type 2 diabetes, CVD, and stroke [The mechanism of the anti-obesity effect of NAOs was confirmed in several preclinical studies, including weight loss, adipocyte size reduction, blood glucose and lipid improvement through PPAR-r and MAPK signaling pathways, adiponectin regulation, and gut microbiome modulation [This study found no differences in biomarkers except VFA, VSR, weight, and BMI. Obesity is influenced by various factors, including individual characteristics, dietary intake, and physical activity [Placebo is used to control for placebo effects in randomized clinical trials (RCTs) because it is necessary to blind researchers or subjects to prevent influence on study results. A placebo looks like a test product but contains no active ingredients. Placebos must have the same appearance, same dosage, same delivery method, and be taken at the same time at the same frequency [In preclinical studies, NAOs decreased total cholesterol, triglyceride, and LDL-C and increased HDL-C in the blood of animal models [In this clinical trial, no side effects or serious adverse reactions were observed in blood tests, electrocardiograms, or vital signs, or reported in interviews. These results confirm that daily intake of NAO for 16 weeks is safe for humans.Our study is the first human study about the anti-obesity effect of NAOs. However, a few limitations of this study should be considered. First, although the number of subjects was calculated by referring to previous similar studies, the sample size was small, limiting our findings’ generalizability. Large-scale studies are needed in the future. Second, regarding the gender of subjects, all subjects in this study were women. It is generally known that the body fat percentage and incidence of obesity are higher in women than in men [However, our study has a good design and advantages. It can provide substantial evidence for the anti-obesity effect of NAOs.