Effects of Greenselect Phytosome® on Weight Maintenance After Weight Loss in Obese Women

Placebo Controlled, Randomized, Single Blinded Trial on the Effects of Greenselect Phytosome® on Weight Maintenance in Obese Women After a 3-month Weight Loss Intervention

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.

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.

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.

Partecipants received twice a day for 3 months placebo (undistinguishable from Globes in terms of size, shape, taste, odor, primary and secondary packaging).

At the end of a 3-month lifestyle intervention, all participants received twice a day for 3 months Globes® and attended a monthly clinical visit during the supplementation period and 3 months after the end of supplementation.

At the end of a 3-month lifestyle intervention, all participants received twice a day for 3 months placebo and attended a monthly clinical visit during the supplementation period and 3 months after the end of supplementation.

change in body weight from 12 weeks of supplementation to 3 months after discontinuation of supplementation

change in waist circumference from 12 weeks of supplementation to 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)

Body composition was measured using a body composition analyzer with joined function of body fat analysis (Biki 300, Jawon Medical, Korea)

Body composition was measured using a body composition analyzer with joined function of body fat analysis (Biki 300, Jawon Medical, Korea)

Body composition was measured using a body composition analyzer with joined function of body fat analysis (Biki 300, Jawon Medical, Korea)

change in body composition from 12 weeks of supplementation to 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

change in heart rate from 12 weeks of supplementation to 3 months after discontinuation of supplementation

Inclusion Criteria: 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 Exclusion Criteria: breast feeding or pregnancy history of cardiovascular or cerebrovascular events uncontrolled hypertension

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