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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

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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Globes® Dietary Supplement: Placebo Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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).
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.




Primary Outcome Measures :
  1. change in body weight from baseline to 12 weeks of supplementation [ Time Frame: baseline and 12 weeks of supplementation ]

Secondary Outcome Measures :
  1. change in body weight from baseline to 4 weeks of supplementation [ Time Frame: baseline and 4 weeks of supplementation ]
  2. change in body weight from 4 weeks to 8 weeks of supplementation [ Time Frame: 4 weeks and 8 weeks of supplementation ]
  3. change in body weight from 8 weeks to 12 weeks of supplementation [ Time Frame: 8 weeks and 12 weeks of supplementation ]
  4. 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 ]
  5. change in waist circumference from baseline to 12 weeks of supplementation [ Time Frame: baseline and 12 weeks of supplementation ]
  6. change in waist circumference from baseline to 4 weeks of supplementation [ Time Frame: baseline and 4 weeks of supplementation ]
  7. change in waist circumference from 4 weeks to 8 weeks of supplementation [ Time Frame: 4 weeks and 8 weeks of supplementation ]
  8. change in waist circumference from 8 weeks to 12 weeks of supplementation [ Time Frame: 8 weeks and 12 weeks of supplementation ]
  9. 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 ]
  10. 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)

  11. change in blood pressure from baseline to 12 weeks of supplementation [ Time Frame: baseline and 12 weeks of supplementation ]
  12. change in heart rate from baseline to 12 weeks of supplementation [ Time Frame: baseline and 12 weeks of supplementation ]
  13. 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)

  14. change in blood pressure from baseline to 4 weeks of supplementation [ Time Frame: baseline and 4 weeks of supplementation ]
  15. change in heart rate from baseline to 4 weeks of supplementation [ Time Frame: baseline and 4 weeks of supplementation ]
  16. 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)

  17. change in blood pressure from 4 weeks to 8 weeks of supplementation [ Time Frame: 4 weeks and 8 weeks of supplementation ]
  18. change in heart rate from 4 weeks to 8 weeks of supplementation [ Time Frame: 4 weeks and 8 weeks of supplementation ]
  19. 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)

  20. change in blood pressure from 8 weeks to 12 weeks of supplementation [ Time Frame: 8 weeks and 12 weeks of supplementation ]
  21. change in heart rate from 8 weeks to 12 weeks of supplementation [ Time Frame: 8 weeks and 12 weeks of supplementation ]
  22. 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)

  23. 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 ]
  24. 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 ]
  25. the proportion of women with ≥ 5% weight loss [ Time Frame: at 4 weeks of supplementation ]
  26. the proportion of women with ≥ 5% weight loss [ Time Frame: at 8 weeks of supplementation ]
  27. the proportion of women with ≥ 5% weight loss [ Time Frame: at 12 weeks of supplementation ]
  28. the proportion of women with ≥ 5% weight loss [ Time Frame: 3 months after discontinuation of supplementation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02542449


Locations
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Italy
IRCCS Istituto Auxologico Italiano
Milano, Italy, 20145
Sponsors and Collaborators
Istituto Auxologico Italiano
Investigators
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Principal Investigator: Cecilia Invitti, MD Istituto Auxologico Italiano

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Istituto Auxologico Italiano
ClinicalTrials.gov Identifier: NCT02542449     History of Changes
Other Study ID Numbers: 19A301_2013
First Posted: September 7, 2015    Key Record Dates
Last Update Posted: September 7, 2015
Last Verified: August 2015

Keywords provided by Istituto Auxologico Italiano:
Green tea
weight maintenance
obesity
fat mass

Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms