Efficacy and Safety of Sinetrol-XPur on Weight and Body Fat Reduction in Overweight or Obese Adults: A 12-Week, Randomized, Double-Blind, Parallel, Placebo-Controlled Trial

Abstract

This study investigated the effect of Sinetrol-XPur on weight and body fat reduction in overweight or obese Korean participants. Among 100 overweight or obese participants enrolled in a 12-week randomized, double-blinded, controlled study, 86 participants completed the trial. Participants took either two Sinetrol-XPur tablets (450 mg per tablet) or two placebo tablets once a day. Bodyweight, body fat percentage, body mass index (BMI), body fat mass, waist circumference, and various safety parameters were measured. After the 12-week intervention, a significant reduction was observed in the body fat mass (P = .030) by dual-energy X-ray absorptiometry (DEXA), body weight (P = .002), and BMI (P = .002) compared to the placebo. Body fat percentage (P = .007) by DEXA showed a significant reduction in the Sinetrol-XPur group, but no difference compared to the control group. Abdominal metabolic risks by computed tomography and blood biochemistry analysis were significantly decreased in the Sinetrol-XPur group, but there were no differences between the Sinetrol-XPur and placebo groups. Safety profiles were not different between the two groups. These results suggested that Sinetrol-XPur significantly reduced body weight, body fat mass, and BMI in obese Korean subjects, which confirms the antiobesity effect of Sinetrol-XPur in the Korean population.

Safety of Anti-Obesity Agents in Adults Narrative Review

“…Regarding the safety profile of some anti-obesity agents such as sinetrol-XPur, IQP-AE-103,Green tea and litramine, it is unclear due to small sample size, short duration of follow up and underreporting of side effects, based on such limitations it is difficult to discuss its safety profile, more reassuring results in need upon phase III trial (13,21,39,60). 1393 Notably, cathine safety profile can predispose cardiovascular events (tachycardia, hypertension, ischemia and QT interval prolongation).…”

“…No significant differences were observed between the two groups for safety parameters.No moderate or severe side effects were observed during the intervention study. (13) Efpeglenatide: Efpeglenatide one of glucagon-like peptide-1 receptor agonists (GLP-1RAs) that can reduce body weight by promoting satiety and reducing food intake, through peripheral and potentially through direct actions on the central nervous system (CNS). (14)(15)(16) In phase II, randomized, placebo-controlled, double-blind trial, participants with a body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 with comorbidity were randomized 1:1:1:1:1 to efpeglenatide (4 mg once weekly, 6 mg once weekly, 6mg once every 2 wk, or 8 mg once every 2 wk; n = 237) or placebo (n = 60) in combination with a hypocaloric diet.…”

A Food Supplement with Antioxidative Santa Herba Extract Modulates Energy Metabolism and Contributes to Weight Management

“…They show chemical similarity to the flavonoids present in citrus extracts, which have been frequently investigated for their slimming effects. 32,33 Future investigations should assess to which extent the described actions of Santa herba extract…”

Pharmacological Properties of Polyphenols: Bioavailability, Mechanisms of Action, and Biological Effects in In Vitro Studies, Animal Models, and Humans

“…In a trial conducted in Korea, anthropometric indicators were evaluated after a 12-week intake of 900 mg/day citrus flavonoids containing preparation Sinestrol-XPur. The overweight and obese adults in the intervention group had a statistically significant decrease in BMI and body fat mass compared to the controls [107]. A study on healthy adults observed that a 10-day intake of a beverage containing 165 mg black tea polyphenols statistically significantly increased fecal lipid excretion in the treatment versus placebo group, but did not cause any changes in the anthropometric parameters of the study participants [108].…”