Study 1 : Weight gain for seniors

Protibis cookies increase the weight and the appetite of malnourished elderly.

The pleasure to eat a solid snack, the confort reduced diarrhea  and pressure ulcer.




This multicentric randomized controlled trial aimed to evaluate the impact of a solid dietary supplement (DS) on weight gain of institutionalized elderly >70 with protein-energy malnutrition.


The innovation of these high protein-high energy cookies was to regain the pleasure to eat thanks to the texture adapted to edentulous patients (Protibis®, France).


All participants received the standard institutional diet, including eventual dairy DS. Intervention group received 8 cookies daily (10.7 g of protein, 224.6 kcal) for 6 weeks. Weight increased in comparison to Control group without cookies supplementation (n=82 vs 72: +1.6 % vs -0.7 %, p=0.038). Weight gain persisted 1-month (+3.0 % vs -0.2 %, p=0.025) and 3-month later (+3.9 % vs -0.9 %, p=0.0034), with a reduction of diarrhea (p=0.027). There was a synergistic effect with liquid/creamy dietary supplements.


Subgroup analysis confirmed the impact cookies supplementation alone on weight (p=0.024), appetite increase (p=0.009) and reduction of pressure ulcers (p=0.031). After a 3-month survey, only 1 % of patients in Intervention group suffered from diarrhea, compared to 8 % in the Control group.



Pouyssegur V, Brocker P, Schneider SM, Philip JL, Barat P, Reichert E, Breugnon F, Brunet D, Civalleri B, Solere JP, Bensussan L, Lupi-Pegurier L.
An innovative solid oral nutritional supplement to fight weight loss and anorexia: open, randomised controlled trial of efficacy in institutionalised, malnourished older adults.
Age Ageing 2015;44:245-251



Oral health alterations worsen the risk of malnutrition. We assayed a new Dietary Supplement (DS) with an innovative solid texture. This DM can be crunched and chewed even by elderly people suffering from a poor oral health (Galettes Protibis®, Solidages, France). This DM is presented as small butter cookies enriched with milk proteins (casein).


Objective of the study

To evaluate the impact of a 6-week period of cookies consumption on the weight gain of 200 malnourished elderly, living in 7 nursing homes.

Participants follow-up: 5 & 1/2 months.


This multicentric controlled randomized trial aimed to compare the Intervention group (with Protibis cookies) vs Control group (no cookies supplementation). The study was designed with 5 visits (week w-4, w0, w6, w10 and w18).

All participants received the standard institution diet, including eventual home made sweets enriched in proteins or liquid/creamy DS (“dairy DS”). Intervention group received 8 cookies daily (11.5 g of protein, 244 kcal) for 6 weeks (from w0 to w6). 

Inclusion criteria: elderly people >70 living in institution.
Main evaluation criteria: % of weight variation (weight in kg).
Secondary evaluatin criteria: appetite scored from 0 to 10 on a Visual Analogic Scale (VAS), pressure ulcer and diarrhea episodes (in % of patients with a current episode).

Comparison of quantitative data (χ² or Fischer’s test) et qualitative  data (Student’s t test or Mann-Whitney’s test) was realized by a statistician blind to group randomization. Significance was accepted at 5 % (SPSS 18, Windows).


This study was realized from January, 2009 to May, 2013. A total of 196 subjects were eligible , 184 randomized and 154 analyzed (Cookies group: 82 subjects; Control Group: 72 subjects). Subjects excluded: weight measure impossible because asthenia and/or pressure ulcer.

No side effect was attributed to Protibis cookies. Both group were similar at baseline: 86 years + 7; 75 % women ; Mini Mental Score 18.1 + 8.3/30; Groupe Iso Ressource 2.8 + 1.3/6; Mini Nutritional Assessment® 14.6 + 4.5/30 ; IMC 19.2 kg/m² + 2.9; albuminemia 34.9 g/L + 4.5.

Oral health was altered:

- Mean masticatory ability 34% + 37 / 100%.
- Dentures wearing (maxillary 37 %; mandibular 33 %).
- Complaints of oral dryness (55 %), oral pain (14 %) and eating difficulties related to edentulousness (36 %).

The consumption of Protibis cookies resulted in weight gain (+1.6 % vs – 0.7 %; p= 0.038), persistent 1 month and 3 months later (respectively +3.0 % vs -0.2 %; p=0.025 and +3.9 % vs -0.9 %;  p=0.0034). Similarly, appetite increased with cookies consumption (+0.44 vs +0.15), and this effect persisted 1 month and 3 months later (respectively +0.61 vs +0.20 and +0.78 vs +0.19).

In both groups, there was a similar evolution as regards: death (8.6 %), falls (0.4+ 0.9 per resident), fractures (0.06 + 0.29), number of infection episodes (0.3 + 1.0) and number of antibiotic days (1.0 + 3.4). However, there were less pressure ulcer episodes after cookies consumption (from 23.9 %  to 8.0 %; p=0.001), but not in the Control group (from 15.3 % to 6.9 %; p=0.11). A the end of the study, there were less diarrhea episodes in the Cookies group than in the Control group (1.1 % vs 8.0 %; p=0.027).

Fig. 2 to 5: analysis in 4 sub-groups, from w0 to w18, showed weight gain (p=0.024) and an appetite increase (p=0.009) related to cookies alone with a daily supplement of 8 cookies/d and 10.7 g of protein/d.  There was also a reduction of pressure ulcer episodes from w0 to w6  (17.1 % to 2.5 %;p=0.031), from w0 to w10 (16.7 % to 2.3 %; p=0.031) and from w0 to 18 (no pressure ulcer).  In the subgroup “Dairy DS + Protibis cookies”, there was a reduction of pressure ulcer episodes too, which was nearly significant from w0 to w6 (37.1 % to 17.1%; p=0.065) and significant from w0 to 10 (35.5 % to 8.8 %; p=0.012).

Despite patients having not been randomized for dairy DS, however, these results tend to show a synergy between dairy DM and Protibis cookies.

Increase of weight   Increase of appetite  
 Reduction of pression ulcer    Reduction of diarrhea  



• Protibis cookies constitute a valuable alternative to mixed or mashed food, based on the pleasure to crunch a small butter cookie, with a familiar non-medical aspect.

•These cookies are adapted to elderly people with a poor oral health.

• These cookies allow an increase of weight and appetite, as well as  a reduction of pressure ulcer and diarrhea episodes.

• The results of this clinical study suggest a synergy between dairy DS and Protibis cookies.



1. HAS : Haute Autorité de Santé. Recommandations professionnelles. Stratégie de prise en charge en cas de dénutrition protéino-énergétique chez la personne âgée. Avril 2007.

2. Hort J, O’Brien JT, Gainotti G et al. European Federation of the Neurological Societies. EFNS Panel on Dementia. EFNS guidelines for the diagnosis and management of Alzheimer disease. Eur J Neurol 2010;17:1236-1248.

3. Shah RC. Medical foods for Alzheimer’s disease. Drugs Aging 2011;28:421-428.

4. Salva A, Andrieu S, Fernandez E et al. Health and nutrition promotion program for patients with dementia (NutriAlz): cluster randomized trial. J Nutr Health Aging 2011:15:822-830.

5. Lafont C, Gérard S, Voisin T et al. Reducing « iatrogenic disability » in the hospitalized frail elderly. J Nutr Health Aging 2011;15:640-655.

6. Simmons SF, Keeler E, Zhuo X et al. Prevention of unintentional weight loss in nursing home residents : Controlled trial of feeding assistance. J Am Geriatr Soc 2008;56:1466-1473.

7. Bernstein MA, Tucker KL, Ryan ND et al. Higher dietary variety is associated with better nutritional status in frail elderlypeople. J Am Diet Assoc 2002;102:1096-1104.

8. Hollis JH, Henry CJ. Dietary variety and its effect on food intake of elderly adults. J Hum Nutri Diet 2007;20:345-351.

9. Donini LM, Dominguez LJ, Barbagallo EM et al. Senile anorexia in different geriatric settings in Italy. J Nutr Health Aging 2011;15:775-781.

10. Suzuki K, Nomura T, Sakurai M et al. Relationship between number of present teeth and nutritional intake in institutionalized elderly. Bull Tokyo Dent Coll 2005;46:135-143

11. Madinier I, Starita-Geribaldi M, Berthier F et al. Detection of mild hyposalivation in the elderly based on the chewing time of specifically-designed disc-tests: diagnostic accuracy. J Am Geriatr Soc 2009;57:691-696.

12. Philip JL. Lutter contre la dénutrition des malades Alzheimer, un exemple. La Revue de Gériatrie 2012 ;37 :141-142.

13. Prêcheur I, Brocker P, Schneider S et al. Un complément nutritionnel oral solide pour lutter contre la dénutrition protéino-énergétique chez les personnes ayant un mauvais état bucco-dentaire. Submitted.

14. Milne AC, Potter J, Avenell A. Cochrane collaboration. Protein and energy supplementation in elderly people at risk for malnutrition (Review). Cochrane Database Syst Rev 2005;Apr 18 (2):CD003288.

15. Société scientifique d’hygiène alimentaire (SSHA). Evaluation sensorielle, manuel méthodologique. Ed. Tec&Doc, Lavoisier éd., Ed. Tec&Doc, Lavoisier éd., 353 p, 2ème édition, Paris 1998.

16. Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomized trials. Ann Int Med 2010;152:726-732.

17. Simons JP, Aaronson NK, Vansteenkiste JF et al. Effects of medroxyprogesterone acetate on appetite, weight, and quality of life in advanced stage non-hormone-sensitive cancer: a placebo-Controlled multicenter study. J Clin Oncol 1996; 14:1077-1084.

18. Milne AC, Potter J, Vivanti A, Avenell A. Cochrane collaboration. Protein and energy supplementation in elderly people at risk for malnutrition (Review). Cochrane Database Syst Rev 2009;Apr 15 (2):CD003288.

19. Grabenhorst F, Rolls ET. The representation of oral fat texture in the human somatosensory cortex. Hum Brain Mapp 2013 Sep 3. doi: 10.1002/hbm.22346. [Epub ahead of print]

20. Black J, Baharestani MM, Cuddigan J et al. National pressure ulcer advisory panel’s updated pressure ulcer staging system. Dermatol Nurs 2007;19:343-349

21. Whelan K, Judd PA, Taylor MA. Assessment of fecal output in patients receiving enteral tube feeding: validation of a novel chart. Eur J Clin Nutr 2004;58:1030-1037.

22. Reddy M, Gill SS, Kalkar SR et al. Treatment of pressure ulcers: a systematic review. JAMA 2008;300:2647-2662.

23. Cereda E, Gini A, Pedrolli C, Vanotti A. Disease-specific, versus standard, nutritional support for treatment of pressure ulcers in institutionalized older adults: a randomized controlled trial. J Am Geriatr Soc 2009;57:1395-1402.

24. Van Hanholt RD, Sobotka L, Meijer EP et al. Specific nutritional support accelerates pressure ulcer healing and reduces wound care intensity in non-malnourished patients. Nutrition 2010;26:867-872.

 25. Whelan K, Schneider SM. Mechanisms, prevention, and management of diarrhea in enteral nutrition. Curr Opin Gastroenterol 2011;27:152-159.