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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Globes®
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Globes®<br>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. | Dietary Supplement: Globes®<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Partecipants received twice a day for 3 months placebo (undistinguishable from Globes in terms of size, shape, taste, odor, primary and secondary packaging). | Dietary Supplement: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in body weight from baseline to 12 weeks of supplementation |  | baseline and 12 weeks of supplementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 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 | Body composition was measured using a body composition analyzer with joined function of body fat analysis (Biki 300, Jawon Medical, Korea) | baseline and 12 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 baseline to 12 weeks of supplementation |  | 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) | baseline and 4 weeks of supplementation | 
| change in blood pressure from baseline to 4 weeks of supplementation |  | baseline and 4 weeks 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 | Body composition was measured using a body composition analyzer with joined function of body fat analysis (Biki 300, Jawon Medical, Korea) | 4 weeks and 8 weeks 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 | 
| 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) | 8 weeks and 12 weeks of supplementation | 
| 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 | Body composition was measured using a body composition analyzer with joined function of body fat analysis (Biki 300, Jawon Medical, Korea) | 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 |  | 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 | 
| the proportion of women with ≥ 5% weight loss |  | at 8 weeks of supplementation | 
| the proportion of women with ≥ 5% weight loss |  | at 12 weeks of supplementation | 
| the proportion of women with ≥ 5% weight loss |  | 3 months after discontinuation of supplementation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Green tea, weight maintenance, obesity, fat mass