Effects of Greenselect Phytosome® on weight maintenance after weight loss in obese women: A randomized placebo-controlled study

Abstract

Background:
Most subjects regain weight after weight loss due to compensatory adaptations finalized to maintain stable body energy stores. Green tea (GT) preparations, which help maintain energy expenditure while dieting could be a useful strategy to facilitate weight maintenance. The usefulness of GT preparations in weight maintenance has been poorly studied so far with conflicting results. This study evaluated if a supplement of GSP and piperine helps obese women to maintain the weight loss obtained with a 3-month lifestyle intervention.

Methods:
In a randomized placebo-controlled study, we examined whether a highly bioavailable GT extract may counteract weight regain after weight loss. Forty obese women (age 50.1 ± 10.1 years, Body Mass Index (BMI) 36.3 ± 2.7 kg/m(2)) underwent a 3-month lifestyle intervention. At the end of the intervention, the women were randomized in two groups for the weight-maintenance phase: 20 of them were prescribed twice a day, for 3 months, with a formula containing 150 mg/dose of Greenselect Phytosome® and 15 mg/dose of pure piperine (GSP group), and 20 were given placebo (P group). Anthropometric measures and body composition were measured before (V-3) and after lifestyle intervention (V0), 1 (V1), 2 (V2), and 3 (V3) months after prescribing supplements and 3 months following the discontinuation of supplements (V6).

Results:
Lifestyle intervention induced a significant weight reduction in both groups with similar weight change (-6.2 ± 2.6 in GSP group vs. -4.8 ± 3.1 % in P group). In the GSP group, V1 in comparison to V0, had further reduction in weight and fat mass, which remained stable at V2 and V3 and increased at V6. In the P group, weight and fat mass increased from V2 onwards. Weight changes in GSP group and P group from V0 to V3 were -1.0 kg (95 % CI -2.5 to +0.5) and + 0.3 kg (95 % CI -0.9 to +1.6), respectively. The proportion of women with weight loss ≥ 5 % was greater in the GSP group than in the P group (75 % vs. 45 % at V1, and 60 % vs. 30 % at V6, p < 0.05 for both groups).

Conclusions:
Greenselect Phytosome® devoid of caffeine may have a clinical potential for the maintenance of weight after intentional weight loss.

Trial registration:
Clinicaltrials.gov NCT02542449 (September 2015).

Full text

R E S E A R C H A R T I C L E Open Access
Effects of Greenselect Phytosome®
on weight maintenance after weight
loss in obese women: a randomized
placebo-controlled study
Luisa Gilardini
1*
, Lucia Pasqualinotto
1
, Francesco Di Pierro
2
, Paolo Risso
3
and Cecilia Invitti
1
Abstract
Background: Most subjects regain weight after weight loss due to compensatory adaptations finalized to maintain
stable body energy stores. Green tea (GT) preparations, which help maintain energy expenditure while dieting could
be a useful strategy to facilitate weight maintenance. The usefulness of GT preparations in weight maintenance has
been poorly studied so far with conflicting results. This study evaluated if a supplement of GSP and piperine helps
obese women to maintain the weight loss obtained with a 3-month lifestyle intervention.
Methods: In a randomized placebo-controlled study, we examined whether a highly bioavailable GT extract may
counteract weight regain after weight loss. Forty obese women (age 50.1 ± 10.1 years, Body Mass Index (BMI)
36.3 ± 2.7 kg/m
2
) underwent a 3-month lifestyle intervention. At the end of the intervention, the women were
randomized in two groups for the weight-maintenance phase: 20 of them were prescribed twice a day, for 3 months,
with a formula containing 150 mg/dose of Greenselect Phytosome® and 15 mg/dose of pure piperine (GSP group),
and 20 were given placebo (P group). Anthropometric measures and body composition were measured before (V-3)
and after lifestyle intervention (V0), 1 (V1), 2 (V2), and 3 (V3) months after prescribing supplements and 3 months
following the discontinuation of supplements (V6).
Results: Lifestyle intervention induced a significant weight reduction in both groups with similar weight change
(−6.2 ± 2.6 in GSP group vs. −4.8 ± 3.1 % in P group). In the GSP group, V1 in comparison to V0, had further reduction
in weight and fat mass, which remained stable at V2 and V3 and increased at V6. In the P group, weight and fat mass
increased from V2 onwards. Weight changes in GSP group and P group from V0 to V3 were −1.0 kg (95 % CI −2.5
to +0.5) and + 0.3 kg (95 % CI −0.9 to +1.6), respectively.
The proportion of women with weight loss ≥5 % was greater in the GSP group than in the P group (75 % vs. 45 % at
V1, and 60 % vs. 30 % at V6, p< 0.05 for both groups).
Conclusions: Greenselect Phytosome® devoid of caffeine may have a clinical potential for the maintenance of weight
after intentional weight loss.
Trial registration: Clinicaltrials.gov NCT02542449 (September 2015)
Keywords: Green tea, Weight maintenance, Obesity, Fat mass
* Correspondence: l.gilardini@auxologico.it
1
Department of Medical Sciences and Rehabilitation, IRCCS Istituto
Auxologico Italiano, Via Ariosto 13, 20145 Milan, Italy
Full list of author information is available at the end of the article
© 2016 The Author(s). Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Gilardini et al. BMC Complementary and Alternative Medicine (2016) 16:233
DOI 10.1186/s12906-016-1214-x
Content courtesy of Springer Nature, terms of use apply. Rights reserved.

Background
Genetic, epidemiological, and physiological studies indi-
cate that body weight is highly regulated, and the
increasing prevalence of obesity reflects the interactions
of genes favoring energy conservation and storage in an
environment that enables access to food calories and a
more sedentary lifestyle. Weight loss can be achieved by
reducing energy intake and at the same time sustaining
energy expenditure. Although weight loss interventions
usually lead to weight loss shortly after intervention,
majority of subjects once again regain weight after the
intervention due to compensatory adaptations finalized
to maintain stable body energy stores. The physiological
adaptation to weight loss involves several biological
pathways mediating the utilization and storage of energy
and the regulation of appetite [1]. In both, lean and
obese individuals, maintenance of a 10 % or greater re-
duction in body weight is associated with a decline in
24-hour energy expenditure of approximately 20–25 %
[2]. The restraint of the decline in energy expenditure
while dieting along with GT preparations could be a use-
ful strategy to facilitate weight maintenance. GT contains
a complex mixture of polyphenolic compounds belong-
ing to the family of catechins, mainly epigallocatechin
gallate, which are responsible for most of the pharmaco-
logical activity of GT. The principal mechanisms of GT
are stimulation of fat oxidation through up-regulation of
lipid-metabolizing enzymes and an increase in norepin-
ephrine levels and energy expenditure through inhibition
of catechol-O-methyltransferase [3].
The ability of GT preparations assisting weight loss
was evaluated in a Cochrane Systematic Review that
included 14 randomized controlled trials [4]. This review
concluded that the weight loss produced by GT prepara-
tions is unlikely to be clinically relevant since it was not
statistically significant in majority of the studies. How-
ever, the usefulness of GT preparations in weight main-
tenance has been poorly studied so far with conflicting
results [4].
Despite the wide “nutraceutical”use of GT, pharmaco-
logical and clinical data show that these molecules are
poorly absorbed orally. Formulation with phospholipids
(Phytosome strategy) however, has shown increased ab-
sorption with some classes of natural products, includ-
ing polyphenolics. Thus, the absorption of Greenselect
Phytosome® (GSP) is about 3-fold higher compared to
the unformulated extract [5], and GSP was also shown
to reduce body weight in subjects with obesity and meta-
bolic syndrome [6, 7]. Currently, a new formulation of
GSP combined with piperine, a thermogenic agent, has
been developed. This new formulation increases the
absorption of various phenolics [8] and enhances the
pharmacodynamics of GSP. This study evaluated whether
dietary supplements of GSP and piperine help obese
women to maintain the weight loss obtained with a
3-month lifestyle intervention.
Methods
Study participants
The study sample consisted of 40 obese Caucasian
women who were recruited from those patients referred
to the IRCCS Istituto Auxologico Italiano for a weight-
loss lifestyle intervention. Women with uncontrolled
hypertension and history of cardiovascular or cerebro-
vascular events were excluded from the study. Sample
size was calculated assuming a ≥5 % weight loss would
be the outcome obtained with 3 months of lifestyle
intervention. The effective size of the study group was
calculated for a binomial test irrespective of weight
loss ≥5 %, looking for at least a difference of 25 % be-
tween the proportion of women reaching this goal in the
placebo and treatment group. We designed our trial with
an alpha error of 5 % and a power of 95 %. Calculation
was performed using G*Power 3.1, obtaining a sample size
of 42 subjects, that was rounded to 20 women for
each group.
The Ethics Committee of the Istituto Auxologico
Italiano approved the study, and all subjects gave their
informed consent after we provided a full explanation of
the study.
Intervention
All obese women completed a 3-month lifestyle interven-
tion. At the end of the intervention, women were randomly
assigned to two groups for the weight-maintenance phase:
20 of them were prescribed supplements twice a day for
3 months and were named GSP group. This included
Globes® (Pharmextracta, Pontenure, Piacenza, Italy), an
enteric coated formulation containing 150 mg/dose of
Greenselect Phytosome®. Greenselect Phytosome® is a
highly standardized extract of Camellia sinensis, titrated
as > 60 % polyphenols and > 40 % in epigallocatechin-O-
gallate, complexed with soy distearoylphosphatidylcholine,
and pure piperine (15 mg/dose) from Piper nigrum L. The
remaining 20 were designated as the P group and received
placebo twice a day for 3 months, which was undistin-
guishable from the active in terms of size, shape, taste,
odor, primary and secondary packaging. Tested dietary
supplements and placebo were both manufactured in
S.I.I.T. srl (Trezzano S/N, Milan, Italy). Randomization was
done using the sealed envelope system and compliance
was checked by counting the left-over and returned cap-
sules. The whole trial was conducted in blind, including
the subjects and the dietician who collected anthropo-
metric measures and assessed the adherence to diet during
dietary supplements and follow-up visits. All women
attended a monthly clinical visit while they were taking
Gilardini et al. BMC Complementary and Alternative Medicine (2016) 16:233 Page 2 of 7
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dietary supplements and 3 months after the end of the sup-
plement intake (Fig. 1).
Lifestyle intervention consisted of weekly individual
sessions for nutritional education, advice reinforcement
on exercise activity and peer group psychological
support. A self-monitor diary, which included details of
food consumption, daily physical activity and emotional
reactions, was used as a tool for education and rein-
forcement. Daily caloric requirement was calculated
using the Harris-Benedict equation and an individual ac-
tivity factor. A diet based on a 500-kcal/d deficit from
the individual estimated caloric requirement was pre-
scribed. The diet, which was high in vegetables, low in
salt and simple sugars consisted of 25 % of total energy
intake as protein, 20 % as fat and 55 % as carbohydrate.
Fresh foods, at least three fish meals per week and
avoiding alcohol, were recommended. The prescribed
physical activity program was 210 min per week consist-
ing of 70 % moderate-intensity aerobic physical activity
and 30 % muscle-strengthening activities. The patient’s
dietary compliance and the average weekly level of phys-
ical activity were recorded at each session. Diet history
and levels of physical activity were collected before and
after the 3-month lifestyle intervention. Food energy and
nutrient intake was calculated using a computerized
database and analysis program (Dietosystem version 3.0;
DS Medica S.r.l., Milan, Italy). Physical activity was
assessed using the short version of the International
physical activity questionnaire (IPAQ) that computes the
Metabolic Equivalent (MET: time spent in physical activ-
ity, expressed in minutes per week) [9].
At the end of the 3-month lifestyle intervention,
women were encouraged to continue with the same diet
and physical activity program recommended during life-
style intervention.
Outcome measures
The primary outcome was the proportion of women
with ≥5 % weight loss during dietary supplements and
three months after their discontinuation in GSP and pla-
cebo group.
The secondary outcomes were the changes in weight
and fat mass during the intake of dietary supplements
and three months after their discontinuation in GSP and
placebo group.
Further outcomes were changes in blood pressure and
heart rate during the intake of dietary supplements and
three months after their discontinuation in GSP and pla-
cebo group.
Measurements
Anthropometric measures, body composition, blood
pressure (BP) and heart rate were measured at V-3, V0,
V1, V2, V3, and V6. Anthropometry was measured using
a body composition analyzer, which measures weight,
height and Body Mass Index (BMI) with joined function
of body fat analysis (Biki 300, Jawon Medical, Korea).
Waist circumference was measured at the level of the
umbilicus. At V0, V3 and V6, the women’s adherence to
the diet was recorded by the dietician using a short
questionnaire (9 items) that provided a score ranging
from 0 to 18, where lower values indicate better adher-
ence (Additional file 1). Three BP measurements sepa-
rated by 5 min were obtained in sitting position at each
visit and mean values were used for the analysis.
Statistical analysis
Analysis of variance was used to compare differences
among groups. Frequencies were compared using a χ
2
test.
Paired t-test was used to compare a) differences between
variables at V0 vs. V-3 in each group (Table 1), b) differ-
ences between weight and fat mass at V0 vs. V-3, at V1 vs.
V0, at V2 vs. V1, at V3 vs. V2 and at V6 vs. V3 (Fig. 3).
Logistic regression analysis was used to evaluate the prob-
ability to have a weight reduction ≥5 % with Globes® with
respect to placebo. A probability value < 0.05 was consid-
ered significant. Data are given as the means ± SD. All
analyses were performed using SPSS version 22.0 (SPSS,
Chicago, IL, US).
Results
The adherence to dietary supplements was complete in
both groups and all subjects completed the study. The
flow of patients in the study is shown in Fig. 2. Table 1
shows the characteristics of obese women belonging to
GSP and P groups before (V-3) and after the 3-month
lifestyle intervention (V0). No differences were observed
between the two groups at V-3 except for the energy
intake that was greater in the GSP group than in the
P group. At V0, the energy intake decreased and physical
activity increased in both groups (Additional file 2). The
intervention induced a significant weight reduction in
both groups with similar weight changes (−6.2 ± 2.6 in
Fig. 1 Study design
Gilardini et al. BMC Complementary and Alternative Medicine (2016) 16:233 Page 3 of 7
Content courtesy of Springer Nature, terms of use apply. Rights reserved.

GSP group vs. −4.8 ± 3.1 % in P group, NS). At V0
anthropometric measures, BP and heart rate were similar
in both groups.
Changes in weight and fat mass during the study
period are depicted in Fig. 3. At the first month of
dietary supplements (V1), the GSP group showed a fur-
ther reduction in weight and fat mass that remained stable
at V2 and V3 and increased three months after discon-
tinuation of the supplements (V6). In the P group, weight
and fat mass started to increase at V2. Weight change
Table 1 Characteristics of obese women of GSP and P group before and after the 3-month lifestyle intervention
GSP group (n= 20) P group (n= 20)
V-3 V0 V-3 V0
Age, years 47.6 ± 10.3 - 52.6 ± 9.6 -
Hypertension, % 10 - 35 -
Diabetes, % 5 - 15 -
Weight, kg 94.3 ± 9.8 88.4 ± 9.1** 90.6 ± 6.6 86.3 ± 5.6**
Waist circumference, cm 112.5 ± 10.0 107.1 ± 10.1** 113.9 ± 5.4 110.3 ± 5.7**
Fat mass, kg 43.0 ± 5.8 40.9 ± 5.7** 41.9 ± 3.5 40.7 ± 3.5*
Fat mass/soft lean mass, ratio 0.98 ± 0.10 0.96 ± 0.11 1.0 ± 0.09 0.99 ± 0.08
Systolic BP, mmHg 126.0 ± 13.9 120.5 ± 10.7* 123.7 ± 10.9 119.2 ± 8.6
Diastolic BP, mmHg 79.0 ± 6.4 77.2 ± 4.7 79.5 ± 6.8 77.5 ± 5.3
Heart rate, beats/min 73.8 ± 8.6 73.1 ± 6.9 73.4 ± 9.1 70.7 ± 6.7*
V-3: before lifestyle intervention. V0: after the 3-month lifestyle intervention-start of dietary supplements. *p< 0.05, **p< 0.0001 compared to V-3. Comparisons
between GSP and P group were NS at –V3 and at V0
Fig. 2 Flow of patients in the study
Gilardini et al. BMC Complementary and Alternative Medicine (2016) 16:233 Page 4 of 7
Content courtesy of Springer Nature, terms of use apply. Rights reserved.

from V0 toV3 was −1.0 kg (95 % CI −2.5 to +0.5) in the
GSP group and+0.3 kg (95 % CI −0.9 to +1.6) in the
Pgroup.
The adherence to the diet progressively decreased in
both groups from V0 to V6. Scores in GSP group were
5.4 ± 3.9 at V3, 2.2 ± 1.3 at V0 (p< 0.05 for V3 vs. V0),
and 6.4 ± 4.9 at V6 (p= NS for V3 vs. V6). The scores in
P group were 5.2 ± 4.0 at V3, 2.8 ± 1.6 at V0 (p< 0.05 for
V3 vs. V0), and 7.8 ± 3.3 at V6 (p< 0.05 for V3 vs. V6).
Advices on physical activity were apparently followed in
both groups because fat-free mass remained stable from
V0 to V6: scores in GSP group were 54.1 ± 3.3 % at V3,
53.8 ± 2.7 % at V0 (p= NS for V3 vs. V0), and 54.6 ± 3.8 %
at V6 (p= NS for V0 and V3). In the P group, the scores
were 52.6 ± 2.9 at V3, 53.0 ± 2.1 at V0 (p<0.05 for V3
vs. V0) and 53.2 ± 5.1 at V6 (p<0.05 when compared
to V0 and V3).
Blood pressure and heart rate remained stable from
V0 to V6 in both groups (data not shown).
The proportion of obese women who maintained a
weight loss ≥5 % was greater in the GSP than in the
Pgroup(75%vs.45%atV1and60%vs.30%at
V6, p< 0.05 for both). The logistic regression analysis
demonstrated a significantly higher probability to main-
tain a ≥5 % weight loss at V1 and V6 in the GSP group
than in the P group (Fig. 4).
Discussion
Results of this study indicate that after a weight loss
intervention, obese women supplemented with GSP are
more likely to maintain the reduction in body weight
achieved with the diet than those receiving placebo. In-
deed, we observed that weight and fat mass decreased
during the first month of dietary supplements with GSP
and then remained stable during the period of supple-
ment intake despite the decrease in the adherence to the
diet. Conversely, the weight and fat mass of women be-
longing to the P group started to rise one month after
the end of the lifestyle intervention. The trend to return
to the pre-body fatness is an expected event after suc-
cessful weight loss because of the occurrence of coordin-
ate actions of behavioral, metabolic, neuroendocrine,
and autonomic responses that are designed to maintain
body energy stores [2]. GT has been shown to stimulate
daily energy expenditure by 4–4.8 % [10, 11], particularly
under conditions of elevated sympathetic tone [12] such
as obesity. GSP may be therefore more useful to offset
the reduction in energy expenditure caused by the adap-
tive thermogenesis when given in association with a
weight loss program. In fact, during a low calorie diet
and adequate physical activity, the increase in the daily
energy expenditure induced by GSP might not be effect-
ive enough due to the overriding effects of the initial
changes in diet and physical activity. This finding is
likely to explain the modest effects of GT on weight loss
reported in the majority of randomized intervention
studies [4, 13].
Few studies reported the effects of GT extracts on
weight maintenance after a period of weight loss in over-
weight and moderately obese subjects. In a study by
Kovasc et al., a 4-week weight loss period with a very
low caloric diet was followed by a 13-week weight main-
tenance period in which, the subjects consumed their
habitual diet and received GT-caffeine mixture or pla-
cebo. No significant differences in body weight regain
were observed between the GT and placebo group how-
ever, a higher weight regain was observed in high caf-
feine consumers [14]. In another study, the same group
confirmed that GT–caffeine mixtures may induce fur-
ther weight reductions during the weight maintenance
Fig. 3 Weight (left panel) and fat mass (right panel) in GSP group (solid line) and P group (dashed line) at V-3, 0, 1, 2, 3 and 6; p values indicate
differences between values at a defined visit and the preceding visit within each group. If the difference is not significant, the p value is not indicated
Fig. 4 Effect of Greenselect Phytosome® compared to placebo on
the probability to maintain a ≥5 % weight loss at V1, 2, 3 and 6
Gilardini et al. BMC Complementary and Alternative Medicine (2016) 16:233 Page 5 of 7
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period only in low-level caffeine consumers [15]. These
studies are not comparable to our study that utilized a
GSP preparation devoid of caffeine, but with active poly-
phenols complexed with soy phospholipids and piperine
to enhance bioavailability and stimulate thermogenesis.
We observed that the effect of Globes® on body fatness
disappears after its discontinuation. This pattern does
not seem be due to a lower adherence to lifestyle recom-
mendations, because in GSP group the adherence to the
diet and fat-free mass (proxy of physical activity) were
similar between the end of the intake of dietary supple-
ments and follow-up. If we consider that the decline of
energy expenditure occurring after weight loss persists
for at least one year [2], it can be assumed that GSP
preparations should be taken for several months after
the intensive phase of a diet to favor weight mainten-
ance. This remains a hypothesis because energy expend-
iture was not assessed in this study. Future research
having energy expenditure and respiratory quotient as
primary endpoints would perhaps shed light on the
mechanisms by which Globes® affect body fatness.
Finally, we emphasize that dietary supplements with
Globes® did not affect blood pressure and heart rate
levels, suggesting that the increase in sympathetic
activity induced by GSP was not associated to significant
cardiovascular changes.
Conclusion
We believe that GSP extracts devoid of caffeine may
have a clinical potential for the maintenance of weight
after the intentional weight loss. More prolonged ran-
domized studies are needed to confirm these effects and
evaluate the dose of GSP required to achieve expected
results.
Additional files
Additional file 1: Questionnaire for the evaluation of adherence to the
diet. (DOCX 16 kb)
Additional file 2: Table S1. Dietary composition and physical activity
of obese women of GSP and P group before and after the 3-month
lifestyle intervention. (DOCX 16 kb)
Abbreviations
BP, blood pressure; GSP, greenselect phytosome®; GT, green tea; MET, metabolic
equivalent; P, placebo; V, visit
Acknowledgements
Not applicable.
Funding
None.
Availability of supporting data
Reference: Dataset GSP trial in LabArchives.
Authors’contributions
LG performed the statistical analysis, interpretation of data and drafted the
manuscript. CI participated in the design and coordination of the study and
in the interpretation of data, and drafting the manuscript. LP recruited
participants and collected data. FDP conceived the study and helped in
interpreting data and revising the manuscript. All authors read and approved
the final manuscript.
Authors’information
Not applicable.
Competing interests
Francesco Di Pierro is the main formulator of Globes®. The other Authors do
not report any conflict of interest.
Consent for publication
Not applicable.
Ethic approval and consent to participate
The Ethics Committee of the Istituto Auxologico Italiano approved the study,
and all subjects gave their informed consent after we provided a full
explanation of the study.
Author details
1
Department of Medical Sciences and Rehabilitation, IRCCS Istituto
Auxologico Italiano, Via Ariosto 13, 20145 Milan, Italy.
2
Scientific Department,
Velleja Research, Milan, Italy.
3
Department of Health Sciences (DISSAL),
University of Genoa, Genoa, Italy.
Received: 9 September 2015 Accepted: 14 July 2016
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