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OpenTrials
Completed

NCT Number: NCT02542449

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

IRCCS Istituto Auxologico Italiano

Milan, Milano, 20145, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Globes®

Dietary Supplement

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

Dietary Supplement

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 outcomes

  1. change in body weight from baseline to 12 weeks of supplementation

    Time frame: baseline and 12 weeks of supplementation

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 7, 2015
Registry last updated
Sep 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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