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

NCT02542449 | Completed Phase 4

• 1 other identifier: 19A301_2013
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Green tea; weight maintenance; obesity; fat mass

Outcome Measures

Primary Outcomes (1)

• change in body weight from baseline to 12 weeks of supplementation

  baseline and 12 weeks of supplementation

Secondary Outcomes (28)

• change in body weight from baseline to 4 weeks of supplementation

  baseline and 4 weeks of supplementation

• change in body weight from 4 weeks to 8 weeks of supplementation

  4 weeks and 8 weeks of supplementation

• change in body weight from 8 weeks to 12 weeks of supplementation

  8 weeks and 12 weeks of supplementation

• 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

• change in waist circumference from baseline to 12 weeks of supplementation

  baseline and 12 weeks of supplementation

Study Arms (2)

Globes®

ACTIVE COMPARATOR

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®

Placebo

PLACEBO COMPARATOR

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

Interventions

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.

Globes®

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

IRCCS Istituto Auxologico Italiano

Milan, Milano, 20145, Italy

Location

Related Publications (9)

• 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.

  PMID: 22029981 BACKGROUND

• 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.

  PMID: 24172301 BACKGROUND

• 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.

  PMID: 23235664 BACKGROUND

• 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.

  PMID: 19594224 BACKGROUND

• 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.

  PMID: 15284381 BACKGROUND

• 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.

  PMID: 10584049 BACKGROUND

• 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.

  PMID: 15005829 BACKGROUND

• 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.

  PMID: 16076989 BACKGROUND

• 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.

  PMID: 27450231 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Cecilia Invitti, MD

  Istituto Auxologico Italiano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2015
• First Posted: September 7, 2015
• Study Start: April 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: September 7, 2015

Record last verified: 2015-08

Locations

IT (1)