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AzTrials

ObesityPhase 4NCT02542449

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

A Phase 4 study testing Globes® in people with Obesity, run by Istituto Auxologico Italiano at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Obesity
What is being tested?
Globes®
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteItaly
Study dates
Apr 2013to Nov 2014
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • breast feeding or pregnancy
  • history of cardiovascular or cerebrovascular events
  • uncontrolled hypertension

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • IRCCS Istituto Auxologico Italiano

    Milan, Milano, 20145

Other trials in Italy

About this study

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

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.

Read the 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.

Conditions
Obesity
Being tested
Globes®, Placebo
Keywords
Green tea, weight maintenance, obesity, fat mass
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • PlaceboDietary 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.

Study groups in NCT02542449
Study groupRoleWhat they receive
Globes®Active comparatorPartecipants 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.
Receives: Dietary Supplement: Globes®
PlaceboPlacebo comparatorPartecipants received twice a day for 3 months placebo (undistinguishable from Globes in terms of size, shape, taste, odor, primary and secondary packaging).
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: baseline and 12 weeks of supplementation

Secondary outcomes (28)
  1. change in body weight from baseline to 4 weeks of supplementation

    Measured: baseline and 4 weeks of supplementation

  2. change in body weight from 4 weeks to 8 weeks of supplementation

    Measured: 4 weeks and 8 weeks of supplementation

  3. change in body weight from 8 weeks to 12 weeks of supplementation

    Measured: 8 weeks and 12 weeks of supplementation

  4. change in body weight from 12 weeks of supplementation to 3 months after discontinuation of supplementation

    Measured: 12 weeks of supplementation and 3 months after discontinuation of supplementation

  5. change in waist circumference from baseline to 12 weeks of supplementation

    Measured: baseline and 12 weeks of supplementation

  6. change in waist circumference from baseline to 4 weeks of supplementation

    Measured: baseline and 4 weeks of supplementation

  7. change in waist circumference from 4 weeks to 8 weeks of supplementation

    Measured: 4 weeks and 8 weeks of supplementation

  8. change in waist circumference from 8 weeks to 12 weeks of supplementation

    Measured: 8 weeks and 12 weeks of supplementation

  9. change in waist circumference from 12 weeks of supplementation to 3 months after discontinuation of supplementation

    Measured: 12 weeks of supplementation and 3 months after discontinuation of supplementation

  10. 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)

    Measured: baseline and 12 weeks of supplementation

  11. change in blood pressure from baseline to 12 weeks of supplementation

    Measured: baseline and 12 weeks of supplementation

  12. change in heart rate from baseline to 12 weeks of supplementation

    Measured: baseline and 12 weeks of supplementation

  13. 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)

    Measured: baseline and 4 weeks of supplementation

  14. change in blood pressure from baseline to 4 weeks of supplementation

    Measured: baseline and 4 weeks of supplementation

  15. change in heart rate from baseline to 4 weeks of supplementation

    Measured: baseline and 4 weeks of supplementation

  16. 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)

    Measured: 4 weeks and 8 weeks of supplementation

  17. change in blood pressure from 4 weeks to 8 weeks of supplementation

    Measured: 4 weeks and 8 weeks of supplementation

  18. change in heart rate from 4 weeks to 8 weeks of supplementation

    Measured: 4 weeks and 8 weeks of supplementation

  19. 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)

    Measured: 8 weeks and 12 weeks of supplementation

  20. change in blood pressure from 8 weeks to 12 weeks of supplementation

    Measured: 8 weeks and 12 weeks of supplementation

  21. change in heart rate from 8 weeks to 12 weeks of supplementation

    Measured: 8 weeks and 12 weeks of supplementation

  22. 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)

    Measured: 12 weeks of supplementation and 3 months after discontinuation of supplementation

  23. change in blood pressure from 12 weeks of supplementation to 3 months after discontinuation of supplementation

    Measured: 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

    Measured: 12 weeks of supplementation and 3 months after discontinuation of supplementation

  25. the proportion of women with ≥ 5% weight loss

    Measured: at 4 weeks of supplementation

  26. the proportion of women with ≥ 5% weight loss

    Measured: at 8 weeks of supplementation

  27. the proportion of women with ≥ 5% weight loss

    Measured: at 12 weeks of supplementation

  28. the proportion of women with ≥ 5% weight loss

    Measured: 3 months after discontinuation of supplementation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2015 (estimated)
  2. Study startApr 2013
  3. Primary completionNov 2014
  4. Study completionNov 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02542449
Sponsor's protocol ID
19A301_2013
Status last verified
Aug 2015
First submitted
1 Sep 2015
Last updated
7 Sep 2015
Results posted
No
Data monitoring committee
No

Publications

  • Sumithran P, Prendergast LA, Delbridge E, Purcell K, Shulkes A, Kriketos A, Proietto J. Long-term persistence of hormonal adaptations to weight loss. N Engl J Med. 2011 Oct 27;365(17):1597-604. doi: 10.1056/NEJMoa1105816.

    PubMed 22029981
  • Hursel R, Westerterp-Plantenga MS. Catechin- and caffeine-rich teas for control of body weight in humans. Am J Clin Nutr. 2013 Dec;98(6 Suppl):1682S-1693S. doi: 10.3945/ajcn.113.058396. Epub 2013 Oct 30.

    PubMed 24172301
  • Jurgens TM, Whelan AM, Killian L, Doucette S, Kirk S, Foy E. Green tea for weight loss and weight maintenance in overweight or obese adults. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD008650. doi: 10.1002/14651858.CD008650.pub2.

    PubMed 23235664
  • Di Pierro F, Menghi AB, Barreca A, Lucarelli M, Calandrelli A. Greenselect Phytosome as an adjunct to a low-calorie diet for treatment of obesity: a clinical trial. Altern Med Rev. 2009 Jun;14(2):154-60.

    PubMed 19594224
  • Lambert JD, Hong J, Kim DH, Mishin VM, Yang CS. Piperine enhances the bioavailability of the tea polyphenol (-)-epigallocatechin-3-gallate in mice. J Nutr. 2004 Aug;134(8):1948-52. doi: 10.1093/jn/134.8.1948.

    PubMed 15284381
  • Dulloo AG, Duret C, Rohrer D, Girardier L, Mensi N, Fathi M, Chantre P, Vandermander J. Efficacy of a green tea extract rich in catechin polyphenols and caffeine in increasing 24-h energy expenditure and fat oxidation in humans. Am J Clin Nutr. 1999 Dec;70(6):1040-5. doi: 10.1093/ajcn/70.6.1040.

    PubMed 10584049
  • Kovacs EM, Lejeune MP, Nijs I, Westerterp-Plantenga MS. Effects of green tea on weight maintenance after body-weight loss. Br J Nutr. 2004 Mar;91(3):431-7. doi: 10.1079/BJN20041061.

    PubMed 15005829
  • Westerterp-Plantenga MS, Lejeune MP, Kovacs EM. Body weight loss and weight maintenance in relation to habitual caffeine intake and green tea supplementation. Obes Res. 2005 Jul;13(7):1195-204. doi: 10.1038/oby.2005.142.

    PubMed 16076989
  • Gilardini L, Pasqualinotto L, Di Pierro F, Risso P, Invitti C. Effects of Greenselect Phytosome(R) on weight maintenance after weight loss in obese women: a randomized placebo-controlled study. BMC Complement Altern Med. 2016 Jul 22;16:233. doi: 10.1186/s12906-016-1214-x.

    PubMed 27450231

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Globes® in people with Obesity, run by Istituto Auxologico Italiano at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in body weight from baseline to 12 weeks of supplementation (time frame: baseline and 12 weeks of supplementation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02542449, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2015.

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