Kashinath Dixit1, Dinesh V Kamath2, Krishnaraju V Alluri3, Barbara A Davis4. 1. Krupa Centre for Diabetes and Obesity, Bengaluru, India. 2. Sudeep Diabetes Care Centre, Bengaluru, India. 3. Laila Nutraceuticals R&D Center, Vijayawada, India. 4. PLT Health Solutions Inc., Morristown, New Jersey.
Abstract
AIM: To re-evaluate the weight loss efficacy of LI85008F in healthy overweight adults via a 16-week randomized, double-blind, placebo-controlled clinical study. MATERIALS AND METHODS: One hundred and forty overweight participants (body mass index [BMI] 27-29.9 kg/m2 , 29.3% male; ages 21-50 years) were randomized into placebo (n =70) and LI85008F (n =70) groups. The participants received either 900 mg/d of LI85008F in two divided doses or two identical placebo capsules. In addition, participants were counselled to follow an ~1800 kcal/d diet and to engage in walking for 30 min, 5 d/wk throughout the study. RESULTS: At the end of the trial period, the LI85008F supplemented group showed significant reductions in body weight (5.36 ± 1.769 vs. 0.87 ± 1.381 kg; P < 0.0001) and BMI (2.05 ± 0.693 vs. 0.34 ± 0.559 kg/m2 ; P < 0.0001), compared with placebo. Significant reductions in waist and hip circumferences, and a 2.08-fold reduction of waist/hip ratio, were noted in the LI85008F supplemented group. LI85008F supplementation also resulted in significant improvements in lipid profiles, compared with the placebo; low-density lipoprotein (LDL) cholesterol decreased, while high-density lipoprotein (HDL) cholesterol increased, resulting in a significantly improved LDL/HDL ratio. No major adverse events were reported by the participants during the study. CONCLUSIONS: The unique herbal extract blend LI85008F, combined with modest calorie restriction and physical activity, is well tolerated, safe, and effective for weight management in overweight men and women.
RCT Entities:
AIM: To re-evaluate the weight loss efficacy of LI85008F in healthy overweight adults via a 16-week randomized, double-blind, placebo-controlled clinical study. MATERIALS AND METHODS: One hundred and forty overweight participants (body mass index [BMI] 27-29.9 kg/m2 , 29.3% male; ages 21-50 years) were randomized into placebo (n =70) and LI85008F (n =70) groups. The participants received either 900 mg/d of LI85008F in two divided doses or two identical placebo capsules. In addition, participants were counselled to follow an ~1800 kcal/d diet and to engage in walking for 30 min, 5 d/wk throughout the study. RESULTS: At the end of the trial period, the LI85008F supplemented group showed significant reductions in body weight (5.36 ± 1.769 vs. 0.87 ± 1.381 kg; P < 0.0001) and BMI (2.05 ± 0.693 vs. 0.34 ± 0.559 kg/m2 ; P < 0.0001), compared with placebo. Significant reductions in waist and hip circumferences, and a 2.08-fold reduction of waist/hip ratio, were noted in the LI85008F supplemented group. LI85008F supplementation also resulted in significant improvements in lipid profiles, compared with the placebo; low-density lipoprotein (LDL) cholesterol decreased, while high-density lipoprotein (HDL) cholesterol increased, resulting in a significantly improved LDL/HDL ratio. No major adverse events were reported by the participants during the study. CONCLUSIONS: The unique herbal extract blend LI85008F, combined with modest calorie restriction and physical activity, is well tolerated, safe, and effective for weight management in overweight men and women.
Keywords:
zzm321990Curcuma longa; zzm321990Moringa oleifera; zzm321990Murraya koeingii; LI85008F; body mass index; body weight management; randomized double-blind placebo-controlled clinical study
Authors: Fikile T Mthiyane; Phiwayinkosi V Dludla; Khanyisani Ziqubu; Sinenhlanhla X H Mthembu; Ndivhuwo Muvhulawa; Nokulunga Hlengwa; Bongani B Nkambule; Sithandiwe E Mazibuko-Mbeje Journal: Front Pharmacol Date: 2022-07-11 Impact factor: 5.988