Effects of Greenselect PhytosomeR On Weight Mainte
Effects of Greenselect PhytosomeR On Weight Mainte
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/m2) 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: [email protected]
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
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Gilardini et al. BMC Complementary and Alternative Medicine (2016) 16:233 Page 2 of 7
dietary supplements and 3 months after the end of the sup- three months after their discontinuation in GSP and pla-
plement intake (Fig. 1). cebo group.
Lifestyle intervention consisted of weekly individual The secondary outcomes were the changes in weight
sessions for nutritional education, advice reinforcement and fat mass during the intake of dietary supplements
on exercise activity and peer group psychological and three months after their discontinuation in GSP and
support. A self-monitor diary, which included details of placebo group.
food consumption, daily physical activity and emotional Further outcomes were changes in blood pressure and
reactions, was used as a tool for education and rein- heart rate during the intake of dietary supplements and
forcement. Daily caloric requirement was calculated three months after their discontinuation in GSP and pla-
using the Harris-Benedict equation and an individual ac- cebo group.
tivity factor. A diet based on a 500-kcal/d deficit from
the individual estimated caloric requirement was pre- Measurements
scribed. The diet, which was high in vegetables, low in Anthropometric measures, body composition, blood
salt and simple sugars consisted of 25 % of total energy pressure (BP) and heart rate were measured at V-3, V0,
intake as protein, 20 % as fat and 55 % as carbohydrate. V1, V2, V3, and V6. Anthropometry was measured using
Fresh foods, at least three fish meals per week and a body composition analyzer, which measures weight,
avoiding alcohol, were recommended. The prescribed height and Body Mass Index (BMI) with joined function
physical activity program was 210 min per week consist- of body fat analysis (Biki 300, Jawon Medical, Korea).
ing of 70 % moderate-intensity aerobic physical activity Waist circumference was measured at the level of the
and 30 % muscle-strengthening activities. The patient’s umbilicus. At V0, V3 and V6, the women’s adherence to
dietary compliance and the average weekly level of phys- the diet was recorded by the dietician using a short
ical activity were recorded at each session. Diet history questionnaire (9 items) that provided a score ranging
and levels of physical activity were collected before and from 0 to 18, where lower values indicate better adher-
after the 3-month lifestyle intervention. Food energy and ence (Additional file 1). Three BP measurements sepa-
nutrient intake was calculated using a computerized rated by 5 min were obtained in sitting position at each
database and analysis program (Dietosystem version 3.0; visit and mean values were used for the analysis.
DS Medica S.r.l., Milan, Italy). Physical activity was
assessed using the short version of the International Statistical analysis
physical activity questionnaire (IPAQ) that computes the Analysis of variance was used to compare differences
Metabolic Equivalent (MET: time spent in physical activ- among groups. Frequencies were compared using a χ2 test.
ity, expressed in minutes per week) [9]. Paired t-test was used to compare a) differences between
At the end of the 3-month lifestyle intervention, variables at V0 vs. V-3 in each group (Table 1), b) differ-
women were encouraged to continue with the same diet ences between weight and fat mass at V0 vs. V-3, at V1 vs.
and physical activity program recommended during life- V0, at V2 vs. V1, at V3 vs. V2 and at V6 vs. V3 (Fig. 3).
style intervention. Logistic regression analysis was used to evaluate the prob-
ability to have a weight reduction ≥5 % with Globes® with
Outcome measures respect to placebo. A probability value < 0.05 was consid-
The primary outcome was the proportion of women ered significant. Data are given as the means ± SD. All
with ≥ 5 % weight loss during dietary supplements and 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
Fig. 1 Study design
both groups with similar weight changes (−6.2 ± 2.6 in
Gilardini et al. BMC Complementary and Alternative Medicine (2016) 16:233 Page 4 of 7
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
GSP group vs. −4.8 ± 3.1 % in P group, NS). At V0 dietary supplements (V1), the GSP group showed a fur-
anthropometric measures, BP and heart rate were similar ther reduction in weight and fat mass that remained stable
in both groups. at V2 and V3 and increased three months after discon-
Changes in weight and fat mass during the study tinuation of the supplements (V6). In the P group, weight
period are depicted in Fig. 3. At the first month of and fat mass started to increase at V2. Weight change
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
from V0 toV3 was −1.0 kg (95 % CI −2.5 to +0.5) in the more likely to maintain the reduction in body weight
GSP group and + 0.3 kg (95 % CI −0.9 to +1.6) in the achieved with the diet than those receiving placebo. In-
P group. deed, we observed that weight and fat mass decreased
The adherence to the diet progressively decreased in during the first month of dietary supplements with GSP
both groups from V0 to V6. Scores in GSP group were and then remained stable during the period of supple-
5.4 ± 3.9 at V3, 2.2 ± 1.3 at V0 (p < 0.05 for V3 vs. V0), ment intake despite the decrease in the adherence to the
and 6.4 ± 4.9 at V6 (p = NS for V3 vs. V6). The scores in diet. Conversely, the weight and fat mass of women be-
P group were 5.2 ± 4.0 at V3, 2.8 ± 1.6 at V0 (p < 0.05 for longing to the P group started to rise one month after
V3 vs. V0), and 7.8 ± 3.3 at V6 (p < 0.05 for V3 vs. V6). the end of the lifestyle intervention. The trend to return
Advices on physical activity were apparently followed in to the pre-body fatness is an expected event after suc-
both groups because fat-free mass remained stable from cessful weight loss because of the occurrence of coordin-
V0 to V6: scores in GSP group were 54.1 ± 3.3 % at V3, ate actions of behavioral, metabolic, neuroendocrine,
53.8 ± 2.7 % at V0 (p = NS for V3 vs. V0), and 54.6 ± 3.8 % and autonomic responses that are designed to maintain
at V6 (p = NS for V0 and V3). In the P group, the scores body energy stores [2]. GT has been shown to stimulate
were 52.6 ± 2.9 at V3, 53.0 ± 2.1 at V0 (p < 0.05 for V3 daily energy expenditure by 4–4.8 % [10, 11], particularly
vs. V0) and 53.2 ± 5.1 at V6 (p < 0.05 when compared under conditions of elevated sympathetic tone [12] such
to V0 and V3). as obesity. GSP may be therefore more useful to offset
Blood pressure and heart rate remained stable from the reduction in energy expenditure caused by the adap-
V0 to V6 in both groups (data not shown). tive thermogenesis when given in association with a
The proportion of obese women who maintained a weight loss program. In fact, during a low calorie diet
weight loss ≥ 5 % was greater in the GSP than in the and adequate physical activity, the increase in the daily
P group (75 % vs. 45 % at V1 and 60 % vs. 30 % at energy expenditure induced by GSP might not be effect-
V6, p < 0.05 for both). The logistic regression analysis ive enough due to the overriding effects of the initial
demonstrated a significantly higher probability to main- changes in diet and physical activity. This finding is
tain a ≥5 % weight loss at V1 and V6 in the GSP group likely to explain the modest effects of GT on weight loss
than in the P group (Fig. 4). reported in the majority of randomized intervention
studies [4, 13].
Discussion Few studies reported the effects of GT extracts on
Results of this study indicate that after a weight loss weight maintenance after a period of weight loss in over-
intervention, obese women supplemented with GSP are 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
Fig. 4 Effect of Greenselect Phytosome® compared to placebo on
confirmed that GT–caffeine mixtures may induce fur-
the probability to maintain a ≥5 % weight loss at V1, 2, 3 and 6
ther weight reductions during the weight maintenance
Gilardini et al. BMC Complementary and Alternative Medicine (2016) 16:233 Page 6 of 7