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

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ClinicalTrials.gov Identifier: NCT02542449
Recruitment Status : Completed
First Posted : September 7, 2015
Last Update Posted : September 7, 2015
Sponsor:
Information provided by (Responsible Party):
Istituto Auxologico Italiano

Tracking Information
First Submitted Date  ICMJE September 1, 2015
First Posted Date  ICMJE September 7, 2015
Last Update Posted Date September 7, 2015
Study Start Date  ICMJE April 2013
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2015)
change in body weight from baseline to 12 weeks of supplementation [ Time Frame: baseline and 12 weeks of supplementation ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2015)
  • 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 [ Time Frame: 12 weeks of supplementation and 3 months after discontinuation of supplementation ]
  • change in body composition from baselineto 12 weeks of supplementation [ Time Frame: 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 [ 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 [ Time Frame: 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 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 [ Time Frame: 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 [ 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 [ Time Frame: 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 [ 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 [ Time Frame: 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 [ 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Greenselect Phytosome® on Weight Maintenance After Weight Loss in Obese Women
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Dietary Supplement: Globes®
    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 Supplement: Placebo
    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.
Study Arms  ICMJE
  • Active Comparator: 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.
    Intervention: Dietary Supplement: Globes®
  • Placebo Comparator: Placebo
    Partecipants received twice a day for 3 months placebo (undistinguishable from Globes in terms of size, shape, taste, odor, primary and secondary packaging).
    Intervention: Dietary Supplement: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 4, 2015)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02542449
Other Study ID Numbers  ICMJE 19A301_2013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Istituto Auxologico Italiano
Study Sponsor  ICMJE Istituto Auxologico Italiano
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Cecilia Invitti, MD Istituto Auxologico Italiano
PRS Account Istituto Auxologico Italiano
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP