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

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

Locations

Italy

IRCCS Istituto Auxologico Italiano

Milano, Italy, 20145

Sponsors and Collaborators

Istituto Auxologico Italiano

Investigators

• Principal Investigator: Cecilia Invitti, MD; Istituto Auxologico Italiano

More Information

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.

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. Review.

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:CD008650. doi: 10.1002/14651858.CD008650.pub2. Review.

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.

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.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gilardini L, Pasqualinotto L, Di Pierro F, Risso P, Invitti C. Effects of Greenselect Phytosome® 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.

• Responsible Party: Istituto Auxologico Italiano
• ClinicalTrials.gov Identifier: NCT02542449 History of Changes
• Other Study ID Numbers: 19A301_2013
• First Posted: September 7, 2015
• 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:

Weight Loss; Body Weight; Signs and Symptoms; Body Weight Changes