Effects of Greenselect Phytosome® on Weight Maintenance After Weight Loss in Obese Women
- Conditions
- Obesity
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Globes®
- Registration Number
- NCT02542449
- Lead Sponsor
- Istituto Auxologico Italiano
- Brief Summary
This study evaluates whether supplementations with a highly bioavailable green tea extract may help obese women to counteract weight regain after a 3-month weight loss intervention.
- Detailed Description
Most obese subjects regain weight after weight loss due to compensatory adaptations finalized to maintain stable body energy stores. In lean or obese individuals, maintenance of a 10% or greater reduction in body weight is associated with a decline in 24-hour energy expenditure of approximately 20%-25%. The restraint of the energy expenditure decline during dieting by green tea (GT) preparations should be a useful strategy to facilitate weight maintenance. To increase absorption of GT, the investigators used a formulation with phospholipids (Greenselect Phytosome® ) added with piperine, a thermogenic agent and a booster of absorption for various phenolics.
At the end of a 3-month lifestyle intervention, all patients giving written informed consent were randomly assigned to two groups for the weight-maintenance phase: 20 of them were supplemented twice a day for 3 months with a dietary supplement (Globes®, Pharmextracta, Pontenure, Piacenza, Italy) and 20 with placebo.Women were blind to the supplementation throughout the whole trial. All women attended a monthly clinical visit during the supplementation period and 3 months after the end of supplementation.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 40
- outpatient
- ≥18 years of age
- body mass index (BMI) ≥ 30 kg/m2
- a sufficient level of education to understand study procedures and be able to communicate with site personnel
- breast feeding or pregnancy
- history of cardiovascular or cerebrovascular events
- uncontrolled hypertension
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Partecipants received twice a day for 3 months placebo (undistinguishable from Globes in terms of size, shape, taste, odor, primary and secondary packaging). Globes® Globes® Partecipants received twice a day for 3 months Globes® (Pharmextracta, Pontenure, Piacenza, Italy) formulated to be enteric-coated and containing 150 mg/dose of Greenselect Phytosome® and pure piperine (15 mg/dose) from Piper nigrum L.
- Primary Outcome Measures
Name Time Method change in body weight from baseline to 12 weeks of supplementation baseline and 12 weeks of supplementation
- Secondary Outcome Measures
Name Time Method change in body weight from baseline to 4 weeks of supplementation baseline and 4 weeks of supplementation change in body weight from 4 weeks to 8 weeks of supplementation 4 weeks and 8 weeks of supplementation change in body weight from 8 weeks to 12 weeks of supplementation 8 weeks and 12 weeks of supplementation change in waist circumference from baseline to 12 weeks of supplementation baseline and 12 weeks of supplementation change in waist circumference from 12 weeks of supplementation to 3 months after discontinuation of supplementation 12 weeks of supplementation and 3 months after discontinuation of supplementation change in blood pressure from 4 weeks to 8 weeks of supplementation 4 weeks and 8 weeks of supplementation change in heart rate from 4 weeks to 8 weeks of supplementation 4 weeks and 8 weeks of supplementation the proportion of women with ≥ 5% weight loss 3 months after discontinuation of supplementation change in body composition from 8 weeks to 12 weeks of supplementation 8 weeks and 12 weeks of supplementation Body composition was measured using a body composition analyzer with joined function of body fat analysis (Biki 300, Jawon Medical, Korea)
change in waist circumference from 4 weeks to 8 weeks of supplementation 4 weeks and 8 weeks of supplementation change in waist circumference from 8 weeks to 12 weeks of supplementation 8 weeks and 12 weeks of supplementation change in body composition from baseline to 4 weeks of supplementation baseline and 4 weeks of supplementation Body composition was measured using a body composition analyzer with joined function of body fat analysis (Biki 300, Jawon Medical, Korea)
change in heart rate from baseline to 4 weeks of supplementation baseline and 4 weeks of supplementation change in body composition from baselineto 12 weeks of supplementation baseline and 12 weeks of supplementation Body composition was measured using a body composition analyzer with joined function of body fat analysis (Biki 300, Jawon Medical, Korea)
change in heart rate from baseline to 12 weeks of supplementation baseline and 12 weeks of supplementation change in blood pressure from baseline to 4 weeks of supplementation baseline and 4 weeks of supplementation change in body composition from 4 weeks to 8 weeks of supplementation 4 weeks and 8 weeks of supplementation Body composition was measured using a body composition analyzer with joined function of body fat analysis (Biki 300, Jawon Medical, Korea)
change in blood pressure from 8 weeks to 12 weeks of supplementation 8 weeks and 12 weeks of supplementation change in body weight from 12 weeks of supplementation to 3 months after discontinuation of supplementation 12 weeks of supplementation and 3 months after discontinuation of supplementation change in waist circumference from baseline to 4 weeks of supplementation baseline and 4 weeks of supplementation change in blood pressure from baseline to 12 weeks of supplementation baseline and 12 weeks of supplementation change in heart rate from 8 weeks to 12 weeks of supplementation 8 weeks and 12 weeks of supplementation change in body composition from 12 weeks of supplementation to 3 months after discontinuation of supplementation 12 weeks of supplementation and 3 months after discontinuation of supplementation Body composition was measured using a body composition analyzer with joined function of body fat analysis (Biki 300, Jawon Medical, Korea)
change in blood pressure from 12 weeks of supplementation to 3 months after discontinuation of supplementation 12 weeks of supplementation and 3 months after discontinuation of supplementation change in heart rate from 12 weeks of supplementation to 3 months after discontinuation of supplementation 12 weeks of supplementation and 3 months after discontinuation of supplementation
Trial Locations
- Locations (1)
IRCCS Istituto Auxologico Italiano
🇮🇹Milano, Italy