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

Istituto Auxologico Italiano

Status and phase: Completed; Phase 4

Conditions: Obesity

Treatments: Dietary Supplement: Globes®; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02542449

19A301_2013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

Globes®

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Globes®

Placebo

Placebo Comparator group

Description:

Partecipants received twice a day for 3 months placebo (undistinguishable from Globes in terms of size, shape, taste, odor, primary and secondary packaging).

Treatment:

Dietary Supplement: Placebo