Obesity
Conditions
Keywords
Green tea, weight maintenance, obesity, fat mass
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.
Interventions
DIETARY_SUPPLEMENTGlobes®
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.
DIETARY_SUPPLEMENTPlacebo
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.
Sponsors
Istituto Auxologico Italiano
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in body weight from baseline to 12 weeks of supplementation | baseline and 12 weeks of supplementation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in body weight from 8 weeks to 12 weeks of supplementation | 8 weeks and 12 weeks of supplementation | — |
| 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 waist circumference from baseline to 12 weeks of supplementation | baseline and 12 weeks of supplementation | — |
| change in waist circumference from baseline to 4 weeks of supplementation | baseline and 4 weeks of supplementation | — |
| 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 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 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 blood pressure from baseline to 12 weeks of supplementation | baseline and 12 weeks of supplementation | — |
| change in heart rate from baseline to 12 weeks of supplementation | baseline 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 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 heart rate 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 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 | — |
| 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 blood pressure from 8 weeks to 12 weeks of supplementation | 8 weeks 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 | — |
| the proportion of women with ≥ 5% weight loss | at 4 weeks of supplementation | — |
| change in blood pressure from baseline to 4 weeks of supplementation | baseline and 4 weeks of supplementation | — |
Countries
Italy
Outcome results
None listed