Clinical trial NCT02542449: Effects of Greenselect Phytosome® on Weight Maintenance After Weight Loss in Obese Women
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Keywords: Green tea
weight maintenance
obesity
fat mass
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2015-09-07
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: change in body weight from baseline to 12 weeks of supplementation
timeFrame: baseline and 12 weeks of supplementation
Secondary outcomes:
measure: change in body weight from baseline to 4 weeks of supplementation
timeFrame: baseline and 4 weeks of supplementation
measure: change in body weight from 4 weeks to 8 weeks of supplementation
timeFrame: 4 weeks and 8 weeks of supplementation
measure: change in body weight from 8 weeks to 12 weeks of supplementation
timeFrame: 8 weeks and 12 weeks of supplementation
measure: change in body weight from 12 weeks of supplementation to 3 months after discontinuation of supplementation
timeFrame: 12 weeks of supplementation and 3 months after discontinuation of supplementation
measure: change in waist circumference from baseline to 12 weeks of supplementation
timeFrame: baseline and 12 weeks of supplementation
measure: change in waist circumference from baseline to 4 weeks of supplementation
timeFrame: baseline and 4 weeks of supplementation
measure: change in waist circumference from 4 weeks to 8 weeks of supplementation
timeFrame: 4 weeks and 8 weeks of supplementation
measure: change in waist circumference from 8 weeks to 12 weeks of supplementation
timeFrame: 8 weeks and 12 weeks of supplementation
measure: change in waist circumference from 12 weeks of supplementation to 3 months after discontinuation of supplementation
timeFrame: 12 weeks of supplementation and 3 months after discontinuation of supplementation
measure: change in body composition from baselineto 12 weeks of supplementation
timeFrame: baseline and 12 weeks of supplementation
measure: change in blood pressure from baseline to 12 weeks of supplementation
timeFrame: baseline and 12 weeks of supplementation
measure: change in heart rate from baseline to 12 weeks of supplementation
timeFrame: baseline and 12 weeks of supplementation
measure: change in body composition from baseline to 4 weeks of supplementation
timeFrame: baseline and 4 weeks of supplementation
measure: change in blood pressure from baseline to 4 weeks of supplementation
timeFrame: baseline and 4 weeks of supplementation
measure: change in heart rate from baseline to 4 weeks of supplementation
timeFrame: baseline and 4 weeks of supplementation
measure: change in body composition from 4 weeks to 8 weeks of supplementation
timeFrame: 4 weeks and 8 weeks of supplementation
measure: change in blood pressure from 4 weeks to 8 weeks of supplementation
timeFrame: 4 weeks and 8 weeks of supplementation
measure: change in heart rate from 4 weeks to 8 weeks of supplementation
timeFrame: 4 weeks and 8 weeks of supplementation
measure: change in body composition from 8 weeks to 12 weeks of supplementation
timeFrame: 8 weeks and 12 weeks of supplementation
measure: change in blood pressure from 8 weeks to 12 weeks of supplementation
timeFrame: 8 weeks and 12 weeks of supplementation
measure: change in heart rate from 8 weeks to 12 weeks of supplementation
timeFrame: 8 weeks and 12 weeks of supplementation
measure: change in body composition from 12 weeks of supplementation to 3 months after discontinuation of supplementation
timeFrame: 12 weeks of supplementation and 3 months after discontinuation of supplementation
measure: change in blood pressure from 12 weeks of supplementation to 3 months after discontinuation of supplementation
timeFrame: 12 weeks of supplementation and 3 months after discontinuation of supplementation
measure: change in heart rate from 12 weeks of supplementation to 3 months after discontinuation of supplementation
timeFrame: 12 weeks of supplementation and 3 months after discontinuation of supplementation
measure: the proportion of women with ≥ 5% weight loss
timeFrame: at 4 weeks of supplementation
measure: the proportion of women with ≥ 5% weight loss
timeFrame: at 8 weeks of supplementation
measure: the proportion of women with ≥ 5% weight loss
timeFrame: at 12 weeks of supplementation
measure: the proportion of women with ≥ 5% weight loss
timeFrame: 3 months after discontinuation of supplementation
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS Istituto Auxologico Italiano
Study officials:
affiliation: Istituto Auxologico Italiano
name: Cecilia Invitti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.