Age and Ageing 2015; 44: 245251

doi: 10.1093/ageing/afu150
Published electronically 16 October 2014

The Author 2014. Published by Oxford University Press on behalf of the British Geriatrics Society.
All rights reserved. For Permissions, please email: journals.permissions@oup.com

An innovative solid oral nutritional supplement

to fight weight loss and anorexia: open,
randomised controlled trial of efficacy in
institutionalised, malnourished older adults

MICORALIS Laboratory, School of Dentistry, University Nice Sophia Antipolis, Nice, France
Department of Dentistry, Nice University Hospital, Nice, France
3
Department of Geriatrics, Nice University Hospital, Nice, France
4
Department of Nutrition, Nice University Hospital, Nice, France
5
Fondation Pauliani, Nice, France
6
EHPAD Tiers Temps, Nice, France
7
La Serena, Clinique Saint Georges, Nice, France
8
EHPAD Les Jardins de la Clairire, Nice, France
9
EHPAD Mariposa, Nice, France
10
EHPAD Les Amaryllis, Nice, France
11
EHPAD Sainte Juliette, Nice, France
12
EHPAD Villa Foch, Nice, France
2

Address correspondence to: V. Pouyssegur. Tel: (+33) 492001111; Fax: (+33) 492001263. Email: valerie.pouyssegur-rougier@unice.fr

Abstract
Background and objective: to evaluate the impact of a solid nutritional supplement on the weight gain of institutionalised
older adults >70 years with protein-energy malnutrition. The innovation of these high-protein and high-energy cookies was
the texture adapted to edentulous patients (Protibis, Solidages, France).
Design: an open, multicentre, randomised controlled trial.
Setting: seven nursing homes.
Participants: one hundred and seventy-ve malnourished older adults, aged 86 8 years.
Intervention: all participants received the standard institutional diet. In addition, Intervention group participants received
eight cookies daily (11.5 g protein; 244 kcal) for 6 weeks (w0w6).
Measurements: ve visits (w4, w0, w6, w10 and w18). Main outcome: percentage of weight gain from w0 to w6 (body
mass in kg). Secondary outcomes: appetite, rated using a numerical scale (0: no appetite to 10: extremely good appetite);
current episodes of pressure ulcers and diarrhea.
Results: average weight increased in Intervention group (n = 88) compared with Control group (n = 87) without cookies supplementation (+1.6 versus 0.7%, P = 0.038). Weight gain persisted 1 month (+3.0 versus 0.2%, P = 0.025) and 3 months
after the end of cookies consumption (+3.9 versus 0.9%, P = 0.003), with diarrhea reduction (P = 0.027). There was a synergistic effect with liquid/creamy dietary supplements. Subgroup analysis conrmed the positive impact of cookies supplementation alone on weight increase (P = 0.024), appetite increase (P = 0.009) and pressure ulcers reduction (P = 0.031).
Conclusion: the trial suggested that, to ght against anorexia, the stimulation of touch (nger food; chewing, even on edentulous gums) and hearing (intra-oral sounds) could be valuable alternatives to sight, smell and taste alterations.
Keywords: anorexia, diarrhea, dietary supplement, pressure ulcer, protein-energy malnutrition, older people

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VALERIE POUYSSEGUR1,2, PATRICE BROCKER3, STPHANE M. SCHNEIDER4, JEAN LUC PHILIP5, PHILIPPE BARAT6,
EWA REICHERT7, FREDERIC BREUGNON8, DIDIER BRUNET9, BRUNO CIVALLERI10, JEAN PAUL SOLERE11,
LINE BENSUSSAN12, LAURENCE LUPI-PEGURIER1,2

V. Pouyssegur et al.

Introduction

246

Methods
Participants

This study was an open, multicentre, randomised controlled

trial in seven nursing homes [1315]. Main inclusion criteria
were age over 70 and malnutrition (Figure 1). Prescription of
home-made sweets enriched with milk proteins and/or
liquid or creamy ONSs (dairy supplements) was not an exclusion criteria. The protocol was approved by the local
Ethics Committee (Espace Ethique Azuren, Nice
University Hospital) (Supplementary data, Appendix 1 available in Age and Ageing online).
Nutritional intervention

All participants received the usual food regimen of the institution. Patients who were prescribed dairy dietary supplements continue to take them. Participants in the Intervention
group additionally received eight Protibis cookies daily for
6 weeks. There was no commercial sponsorship. Each cookie
weighed 6.5 g and contained 1.44 g of protein and 30.5 kcal.
It contained 22% of weight in proteins. Total energy content
in proteins was 19% with an animal/vegetable protein ratio
of 3.5 and a glycaemic index of 46.1. Ingredients were wheat
our, fresh butter, milk protein (casein), sugar, vanilla aroma,
baking powder and salt. There was no palm oil or other vegetable oil. Eight cookies were distributed in the breakfast and/
or in the snack (total 52 g of cookies: 11.5 g of protein and
244 kcal as daily supplementation).
Study design and measures

The study was designed with ve visits (w4, w0, w6, w10
and w18). There was an initial period of 4 weeks to observe
weight evolution, without intervention (w4 to w0).
Participants in the Intervention group received Protibis
cookies for 6 weeks (w0w6). There was then a follow-up
period in both groups with two visits (w10 and w18),
respectively, 1 and 3 months after the end of cookies consumption. At w4 routine, medical data were collected from
patients medical les.

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Protein-energy malnutrition is common in older people, ranging from 410% of community-dwelling seniors, 1538%
of nursing home residents to 3070% of hospitalised older
patients [1]. The main risk factors are alteration of cognitive
functions, frequent acute and chronic diseases, poverty and
social isolation, the use of >34 drugs/day, smell, taste,
vision, auditory and motor alterations and increased energetic needs (surgery, roaming patients). Oral problems constitute another risk of malnutrition, including swallowing
difculties, dry mouth, oral pain, periodontitis and teeth mobility, edentulousness and poorly tted dentures [13].
The resulting protein-energy malnutrition has four cardinal symptoms: asthenia, apathy, anorexia and loss of weight,
with a modication of the physical body composition, immunodeciency and subsequent frailty. There is an increased
frequency of falls, infections (inhalation pneumonia), pressure ulcers, fatigue, dependence, depression, dementia progression and mortality [14]. This disease-to-disease spiral is
difcult to reverse, and malnutrition increases the risk of
hospital admissions and subsequent resettlement in an
institution [5].
Nutritional care must aim to preserve the oral route, and
enteral or parenteral route is an ultimate medical option. It is
recommended that the number of meals and snacks offered
during the day should be increased instead of offering bigger
meals, because anorexic patients prefer small-sized portions.
It is also recommended to avoid night starvation >12 h, to
prefer high-protein and/or high-calorie food adapted to
patients preferences and to give help if necessary during
meals [1, 6]. Dieticians can recommend to enrich food with
eggs, cream, grated cheese, powdered milk and in some cases
with milk protein powder [1, 2]. However, patients may complain of a monotonous milky taste [79]. Besides, homemade enriched dishes generally have a soft texture (soups,
bchamel sauces, gratins, puddings, etc. ). If necessary, caregivers can prescribe brand dietary supplements, which are
generally provided as sweet dairy drinks (sip-feeds) or
creams, enriched in protein and/or energy [1]. High-protein
cookies are generally not proposed to older adults, because
their hard texture is not convenient for edentulous people.
However, edentulous patients often complain of the monotony of mixed, mashed and soft food, which is a well-known
cause of anorexia [9, 10].
To help to prevent and ght against malnutrition in older
adults, a solid dietary supplement designed for people with
chewing difculties has been developed. This supplement
was in the form of a high-protein and high-energy cookie.
The innovation relied on the texture of the cookie, specically designed for patients who regained the pleasure to crunch
and chew, despite a poor dental health or edentulousness
[11]. A preliminary study has shown that 30 institutionalised
older people enjoyed the taste and texture of these butter
cookies (Protibis, Solidages, France) [12]. In a second preliminary test involving 15 institutionalised older adults with
weight loss, patients were given an average number of

4.5 0.5 cookies daily (range: 3.95.3) for 2 months. The

average intake was 6.4 g of protein and 137 kcal daily. Weight
remained stable (1.5% weight variation) or increased for
60% of the subjects (4 and 5 subjects, respectively) after this
2-month period of cookies consumption (unpublished data).
In this study, we hypothesised that a 6-week consumption
period of this innovative oral nutritional supplement (ONS)
would enhance the percentage of weight gain in institutionalised, malnourished older adults. We also wanted to investigate the impact of cookies consumption on other parameters
such as appetite, meal consumption, calories intake, current
episodes of pressure ulcers and diarrhea, number of falls,
fractures, infection episodes, antibiotic days and death.

Nutritional supplement to fight weight loss and anorexia

The main outcome assessment was the percentage of

weight gain from w0 to w6 (body mass in kg). Secondary
outcome was appetite, rated by the participant or by the
nursing staff using a numerical scale ranging from 0 (absolutely no appetite) to 10 (extremely good appetite) [16].
To compare the calorie supplement actually consumed
from w0 to w6 between the two groups, dietary intakes were
measured during 5 days (d0, d3, d6, d40 and d42). Food and
beverage consumption was scored as the percentage of each
serving actually consumed (score 0, 1/3, 2/3 and 1). In one
nursing home (Tiers Temps, Le Cannet), calorie count was
done by the dietician in charge of the menus. We recorded
current episodes of pressure ulcers and diarrhea at baseline
(w4), and current episode or previous episode of pressure
ulcer and diarrhea since the last visit (w0, w6, w10 and
w18). The number of falls, fractures after falls, infection episodes, antibiotic days and deaths from w0 to w18 was also
recorded at w18. Data analysis methodology is detailed in
Supplementary data, Appendix 1 available in Age and Ageing
online.

Results
The study was performed from January 2010 until May 2013.
A total of 216 patients were randomised, but only 175 patients
fullled the inclusion visit at w4 and 154 could be analysed
for the main outcome (Figure 1; Table 1). There was full adherence to the protocol (cookies consumption). No harm or
side effect attributed to Protibis cookies was reported.
Primary outcome

In this population of malnourished older people, there was a

mean loss of weight the month before intervention, both in
the Intervention and in the Control group (0.7 versus
0.1%, respectively). At the end of supplementation with
Protibis cookies, patients in the Intervention group had a signicant and persistent weight gain compared with the
Control group. The average percentage of weight variation
was as follows: from w0 to w6 (+1.6 versus 0.7%), from
w0 to w10 (+3.0 versus 0.2%) and from w0 to w18

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Figure 1. Study prole.

V. Pouyssegur et al.
Table 1. Comparison of baseline characteristics
Intervention group (n = 88)

Control group (n = 87)

T-test P value

23.9 (21)
85.4 7.1
2.7 1.4
18.1 8.4
51.7 1.5
23.9 (21)
34.1 (30)
19.2 2.9
14.5 3.9
34.3 4.6
4.27 2.01
20.5 (18)
15.9 (14)
32.5 36.8
44.3 (39)
10.2 (9)
36.4 (32)
23.9 (21)
25.0 (22)
21.6 (19)

16.1 (14)
86.8 7.1
2.8 1.1
18.1 8.3
50.9 9.9
29.9 (26)
36.8 (32)
19.2 2.9
14.7 5.0
35.4 4.4
5.26 2.22
9.2 (8)
12.6 (11)
35.6 37.0
32.2 (28)
9.2 (8)
37.9 (33)
19.5 (17)
19.5 (17)
17.2 (15)

0.537
0.751
0.325
0.976
0.711
0.626
0.865
0.709
0.095
0.938
0.770
0.055
0.667
0.810
0.040
0.592
0.597
0.347
0.546
0.704

....................................................................................

A total of 216 subjects were assessed for eligibility and randomised to the Intervention group or to the Control group (108 patients in each group). However, the
subjects participating in the study were frail elderly people suffering from malnutrition. Besides, many of them suffered from cognitive impairment too and we could
not obtain familys or tutors informed written consent. For these reasons, 41 participants were randomised following a pre-inclusion visit but could not perform the
inclusion visit 4 weeks before intervention (Intervention group: 20 subjects; Control group: 21 subjects). Case report form was completed and baseline characteristics
were obtained at w4 for the 88 remaining patients in the Intervention group and the 87 remaining patients in the Control group.
Groupe Iso Ressource (GIR), disability index of French Health Authorities ranging from 6 (complete autonomy) to 1 (sick bedridden); ID, identification card; ONS,
oral nutritional supplement.
a
Masticatory ability ranges from 0% (no antagonistic teeth) to 100% (16 pairs of antagonistic teeth); masticatory ability is impaired under 70% [11].

(+3.9 versus 0.9%). Category analysis conrmed these

results, with a weight decrease in both groups from w4 to
w0 (P = 0.245), followed by a signicant weight increase in
the Intervention group from w0 to w6 (P = 0.038), w0 to
w10 (P = 0.025) and w0 to w18 (P = 0.003) (Supplementary
data, Table 2 available in Age and Ageing online).
Secondary outcome

Mean appetite steadily increased in the Intervention group

from w0 to w18 (Supplementary data, Table 3 available in
Age and Ageing online). Supplementation with Protibis
cookies did not reduce or increase the quantity of food and
beverage eaten at meals (Supplementary data, Appendix 2
available in Age and Ageing online).
Other outcomes

There was a greater number of pressure ulcers in the

Intervention group at w4 (P = 0.055), but not at w0
(P = 0.184) (Table 1). Within-group analysis showed a signicant reduction of pressure ulcer episodes from w0 to w6 in
the Intervention group (number of subjects) (23.98.0%;
n = 88; P = 0.001), but not in the Control group (15.36.9%;
n = 72; P = 0.11). Between-group analysis showed that, at the
end of the study, there were less diarrhea episodes in the
Intervention group than in the Control group (w18: 1.1%
(n = 80) versus 8.0% (n = 72); P = 0.027). Besides, at w6, we
observed a higher frequency of diarrhea among patients

248

consuming dairy ONSs than among other patients (11.9%

(n = 84) versus 2.1% (n = 62); P = 0.018). Other outcomes
were similar (Supplementary data, Appendix 2 available in Age
and Ageing online).
Exploratory analysis in four subgroups

Baseline characteristics of participants showed a higher prescription rate of dairy dietary supplements in the Intervention
group (Table 1). In this group, patients who were prescribed
dairy supplements were given a mean number of 1.9 1.2
units daily, ranging from 1 to 6. In the Control group, they
received 1.8 1.5 units daily, ranging from 1 to 5.
We thus realised an exploratory analysis of four subgroups, No supplementation, Dairy ONSs, Protibis
cookies and Dairy ONSs and Protibis cookies, with 48, 27,
46 and 37 subjects, respectively. There was a synergistic
effect between cookies and other oral dietary supplements
(Figure 2). However, subgroup analysis conrmed the positive impact of cookies supplementation alone on weight increase (P = 0.024), appetite increase (P = 0.009) and pressure
ulcers reduction (P = 0.031) (Supplementary data, Appendix
2 available in Age and Ageing online).

Discussion
To our knowledge, this is the rst trial investigating a solid
ONS adapted to people with masticatory impairment. The
percentage change in body weight during a 6-week trial

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Male [% (n)]
Age, year [mean (SD)]
Groupe Iso Ressource (GIR) [mean (SD)]
Mini Mental Score [mean (SD)]
Weight, kg [mean (SD)]
Weight loss >10% in 6 months [% (n)]
Weight loss >5% in 1 month [% (n)]
Body mass index, kg/m2 (size from ID card) [mean (SD)]
Mini Nutritional Assessment (MNA) [mean (SD)]
Albuminaemia, g/l [mean (SD)]
Appetite, score 010 [mean (SD)]
Pressure ulcer, current episode [% (n)]
Diarrhea, current episode [% (n)]
Masticatory ability,a % [mean (SD)]
Prescription of dairy ONS [% (n)]
Oral pain complaint [% (n)]
Dry mouth complaint [% (n)]
Edentulousness with chewing difficulties [% (n)]
Maxillary removable denture [% (n)]
Mandible removable denture [% (n)]

Nutritional supplement to fight weight loss and anorexia

period is a reference outcome for studies assaying nutritional

supplements. The meta-analysis involving older people at
risk of malnutrition was updated in 2009 [17]. It showed that
liquid ONSs (sip-feeds) during a 6-week period allowed an
average increase of 2.2% weight gain. Additional protein
doses ranged from 10 to 36 g daily. In the present study
involving older people suffering from true malnutrition, we
observed a weight gain at the end of the 6-week cookies consumption period (+1.6%), followed by a persistent weight
increase lasting for 1 month (+ 3.0%) and 3 months after the
end of cookies consumption (+3.6%).
The supplement of proteins brought about by eight
Protibis cookies was limited to 11.5 g of protein and 244
kcal daily. This signicant and persistent weight gain and
appetite increase, despite this rather limited protein and
calorie supplementation, could have several explanations.
First, there was a good compliance with eight cookies a day,
while with sip-feeds in particular, the nursing staff cannot
easily control the quantities actually consumed and wasted.
Another explanation could be related to the solid texture of
cookies. Smeets et al. [18] reviewed stimuli involved in salivation and appetite, and how taste, texture and sight of food
trigger a cascade of pre-absorptive physiological responses,
called cephalic phase responses. In the present series, most
of participants had dental alterations (Table 1) and they were
given a soft diet. Cookies specic texture allowed easy crumbling between edentulous jaws. Chewing could have stimulated saliva and other digestive secretions, facilitated the
processing of ingested food, the assimilation of all food supplies and contributed to weight increase [9, 18]. Finally,

weight gain could result from the ght against anorexia,

based on the pleasure to eat a butter cookie with a nonmedical aspect [19]. Actually, butter taste is uncommon
among conventional ONSs. But in patients over 75 years, restrictive diets such as low-cholesterol diet avoiding butter
consumption are not recommended, because they increase
the risk of under-nutrition [20].
However, outcome determination and analysis was not
possible in a high proportion of patients, and the approach
taken (on-treatment analysis) could have led to bias in the
results. Another limitation of this study was the lack of
placebo, which introduces possible bias over some of the
assessments, particularly those which have a subjective
element such as appetite, percentage of normal diet and
uids remaining after a meal and pressure sores. As the
impact of this new solid ONS on pressure sores and diarrhea
was unanticipated, the questions in case report forms had
been limited to Current episode of pressure sore: yes/no
and Current episode of pressure diarrhea: yes/no. In the
absence of precise scoring, the present results should be considered as a preliminary screening. Besides, the main
outcome, weight gain, is presumed to be objective, but it can
be affected by the observer knowing which group a patient is
allocated to.
Another limitation of this study was the use of enriched
sweets and/or sip-feeds by 37.7% of the participants,
without randomisation. This was deliberate in the study
design, because we wanted to diversify the offer of protein
supplementation, without disturbing this frail population
composed of anorexic older people. Thus, we did not wish

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Figure 2. Subgroup analysis. Intervention period with Protibis cookies consumption took place from week0 to week6 (w0 to w6).
ONS: oral nutritional supplement.

V. Pouyssegur et al.

Conclusion
In conclusion, this innovative solid oral dietary supplement
allowed to diversify and to enrich in protein and calories the
diet of institutionalised older adults. The main outcomes
were a positive impact on weight and appetite, and a reduction of pressure ulcer and diarrhea episodes. This trial also
suggested that to ght against anorexia, the stimulation of
touch (nger food; chewing, even on edentulous gums) and

250

hearing (intra-oral sounds) could be valuable alternatives to

sight, smell and taste alterations.

Key points
A solid oral nutritional supplement with a specically
adapted texture can be chewed by edentulous older adults.
An oral nutritional supplement with a solid texture allows
to enrich diet with protein and calories under a small
volume.
The pleasure to crunch and chew is a way to ght anorexia
in older adults used to soft food.

Conflicts of interest
None declared.

Funding
This work was supported by the French Ministry of Higher
Education and Research (grant PTR200909037). Sponsor
played no role in the study.

Supplementary data
Supplementary data mentioned in the text are available to
subscribers in Age and Ageing online.

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