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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02542449
• Other study ID #: 19A301_2013
• Status: Completed
• Phase: Phase 4
• First received: September 1, 2015
• Last updated: September 4, 2015
• Start date: April 2013
• Est. completion date: November 2014

Study information

• Verified date: August 2015
• Source: Istituto Auxologico Italiano
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

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
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.

Locations

Country	Name	City	State
Italy	IRCCS Istituto Auxologico Italiano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

References & Publications (8)

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. — View 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. — View 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. Review. — View 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:CD008650. doi: 10.1002/14651858.CD008650.pub2. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in body weight from baseline to 12 weeks of supplementation		baseline and 12 weeks of supplementation	No
Secondary	change in body weight from baseline to 4 weeks of supplementation		baseline and 4 weeks of supplementation	No
Secondary	change in body weight from 4 weeks to 8 weeks of supplementation		4 weeks and 8 weeks of supplementation	No
Secondary	change in body weight from 8 weeks to 12 weeks of supplementation		8 weeks and 12 weeks of supplementation	No
Secondary	change in body weight from 12 weeks of supplementation to 3 months after discontinuation of supplementation		12 weeks of supplementation and 3 months after discontinuation of supplementation	No
Secondary	change in waist circumference from baseline to 12 weeks of supplementation		baseline and 12 weeks of supplementation	No
Secondary	change in waist circumference from baseline to 4 weeks of supplementation		baseline and 4 weeks of supplementation	No
Secondary	change in waist circumference from 4 weeks to 8 weeks of supplementation		4 weeks and 8 weeks of supplementation	No
Secondary	change in waist circumference from 8 weeks to 12 weeks of supplementation		8 weeks and 12 weeks of supplementation	No
Secondary	change in waist circumference from 12 weeks of supplementation to 3 months after discontinuation of supplementation		12 weeks of supplementation and 3 months after discontinuation of supplementation	No
Secondary	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)	baseline and 12 weeks of supplementation	No
Secondary	change in blood pressure from baseline to 12 weeks of supplementation		baseline and 12 weeks of supplementation	Yes
Secondary	change in heart rate from baseline to 12 weeks of supplementation		baseline and 12 weeks of supplementation	Yes
Secondary	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)	baseline and 4 weeks of supplementation	No
Secondary	change in blood pressure from baseline to 4 weeks of supplementation		baseline and 4 weeks of supplementation	Yes
Secondary	change in heart rate from baseline to 4 weeks of supplementation		baseline and 4 weeks of supplementation	Yes
Secondary	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)	4 weeks and 8 weeks of supplementation	No
Secondary	change in blood pressure from 4 weeks to 8 weeks of supplementation		4 weeks and 8 weeks of supplementation	Yes
Secondary	change in heart rate from 4 weeks to 8 weeks of supplementation		4 weeks and 8 weeks of supplementation	Yes
Secondary	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)	8 weeks and 12 weeks of supplementation	No
Secondary	change in blood pressure from 8 weeks to 12 weeks of supplementation		8 weeks and 12 weeks of supplementation	Yes
Secondary	change in heart rate from 8 weeks to 12 weeks of supplementation		8 weeks and 12 weeks of supplementation	Yes
Secondary	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)	12 weeks of supplementation and 3 months after discontinuation of supplementation	No
Secondary	change in blood pressure from 12 weeks of supplementation to 3 months after discontinuation of supplementation		12 weeks of supplementation and 3 months after discontinuation of supplementation	Yes
Secondary	change in heart rate from 12 weeks of supplementation to 3 months after discontinuation of supplementation		12 weeks of supplementation and 3 months after discontinuation of supplementation	Yes
Secondary	the proportion of women with = 5% weight loss		at 4 weeks of supplementation	No
Secondary	the proportion of women with = 5% weight loss		at 8 weeks of supplementation	No
Secondary	the proportion of women with = 5% weight loss		at 12 weeks of supplementation	No
Secondary	the proportion of women with = 5% weight loss		3 months after discontinuation of supplementation	No