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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
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.
IRCCS Istituto Auxologico Italiano
Milan, Milano, Italy
change in body weight from baseline to 12 weeks of supplementation
Time frame: baseline and 12 weeks of supplementation
change in body weight from baseline to 4 weeks of supplementation
Time frame: baseline and 4 weeks of supplementation
change in body weight from 4 weeks to 8 weeks of supplementation
Time frame: 4 weeks and 8 weeks of supplementation
change in body weight from 8 weeks to 12 weeks of supplementation
Time frame: 8 weeks and 12 weeks of supplementation
change in body weight from 12 weeks of supplementation to 3 months after discontinuation of supplementation
Time frame: 12 weeks of supplementation and 3 months after discontinuation of supplementation
change in waist circumference from baseline to 12 weeks of supplementation
Time frame: baseline and 12 weeks of supplementation
change in waist circumference from baseline to 4 weeks of supplementation
Time frame: baseline and 4 weeks of supplementation
change in waist circumference from 4 weeks to 8 weeks of supplementation
Time frame: 4 weeks and 8 weeks of supplementation
change in waist circumference from 8 weeks to 12 weeks of supplementation
Time frame: 8 weeks and 12 weeks of supplementation
change in waist circumference from 12 weeks of supplementation to 3 months after discontinuation of supplementation
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Time frame: 12 weeks of supplementation and 3 months after discontinuation of supplementation
change in body composition from baselineto 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)
Time frame: baseline and 12 weeks of supplementation
change in blood pressure from baseline to 12 weeks of supplementation
Time frame: baseline and 12 weeks of supplementation
change in heart rate from baseline to 12 weeks of supplementation
Time frame: baseline and 12 weeks of supplementation
change in body composition from baseline to 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)
Time frame: baseline and 4 weeks of supplementation
change in blood pressure from baseline to 4 weeks of supplementation
Time frame: baseline and 4 weeks of supplementation
change in heart rate from baseline to 4 weeks of supplementation
Time frame: baseline and 4 weeks of supplementation
change in body composition from 4 weeks to 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)
Time frame: 4 weeks and 8 weeks of supplementation
change in blood pressure from 4 weeks to 8 weeks of supplementation
Time frame: 4 weeks and 8 weeks of supplementation
change in heart rate from 4 weeks to 8 weeks of supplementation
Time frame: 4 weeks and 8 weeks of supplementation
change in body composition from 8 weeks to 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)
Time frame: 8 weeks and 12 weeks of supplementation
change in blood pressure from 8 weeks to 12 weeks of supplementation
Time frame: 8 weeks and 12 weeks of supplementation
change in heart rate from 8 weeks to 12 weeks of supplementation
Time frame: 8 weeks and 12 weeks of supplementation
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)
Time frame: 12 weeks of supplementation and 3 months after discontinuation of supplementation
change in blood pressure from 12 weeks of supplementation to 3 months after discontinuation of supplementation
Time frame: 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
Time frame: 12 weeks of supplementation and 3 months after discontinuation of supplementation
the proportion of women with ≥ 5% weight loss
Time frame: at 4 weeks of supplementation
the proportion of women with ≥ 5% weight loss
Time frame: at 8 weeks of supplementation
the proportion of women with ≥ 5% weight loss
Time frame: at 12 weeks of supplementation
the proportion of women with ≥ 5% weight loss
Time frame: 3 months after discontinuation of supplementation