Compliance of dairy products versus oral nutrition supplements in patients with a risk for malnutrition.

Malnutrition is a considerable problem within the health care setting.
Prevalence of malnutrition is estimated at about 12 percent in the acute
hospital setting (Halfens et al., 2014). To prevent malnutrition, a
high-protein diet is essential to build muscle mass and improve muscle
function. However, little is known aboutIn this respect, the compliance of
extra intake of protein-rich products is key to maintain and improve
nutritional status. Therefore, protein-rich dietary interventions with a high
compliance may be more beneficial for patients with risk of malnutrition in
order to prevent malnutrition on long term. and effectiveness of dairy food and
oral nutrition supplements in relation to maintain or improve nutritional
status in patients with a risk for malnutrition. We hypothesize that for both
protein rich dairy products and oral nutrition supplements the nutritional
requirements of patients with risk of malnutrition can be met adequately, but
the compliance of these interventions may differ. without the use of oral
nutrition supplements, and that changes in patient*s nutritional status, body
composition and muscle strength will be similar when a dairy based diet or an
oral nutrition supplement based diet is prescribed. Besides, we hypothesize
thatThe patient satisfaction on dairy products maywill be higher because dairy
products are easier to incorporate in the daily eating habits than oral
nutrition supplements.

The main objective is to gain insights inassess the compliance (i.e. adherence
to prescription) of a dairy based diet compared to a diet including oral
nutrition supplement in (out)patients with a risk of malnutrition. dairy
products and oral nutrition supplements in clinical outpatients with risk of
malnutrition. Secondary objective is to gain insights into the potential
improvements in the nutritional status and body composition over time resulting
from the dairy-based diet vs. diet with oral nutritional supplements.

A randomized controlled intervention study.

Participants receive a high-protein diet: the experimental group receives extra
(protein-rich) dairy products, and the control group receives extra oral
nutrition supplements for in between use in order to supplement protein to
their diet. The dietary advice consists of at least 12 gram of protein per day
in addition to the normal protein intake, aiming at a total intake of 1.0 - 1.2
gram protein per kg body weight per day. Both groups will be counselled by a
dietician for 8 weeks, and will receive two consultations in the hospital (week
0, and week 4) and two telephone consultations (week 2 and 6).

As part of the usual care, (out)patients of the UMCG are screened on
malnutrition with the Malnutrition Universal Screening Tool (MUST). In current
UMCG policy,As part of usual care, malnourished outpatients, with a MUST=2
score, are referred to a dietician. Outpatients with a medium risk of
malnutrition (MUST = 0 or 1 point and PG-SGA SF score >= 4 and <9) are not
referred to a dietician. Still, these patients need also dietary advice to
prevent further progress of malnutrition. We will include this group of
patients and offer these patients a high protein diet to prevent malnutrition.
There will be no costs for the participants. All dairy products as well as the
oral nutrition supplements will be provided by the sponsor and distributed by
UMCG dieticians or, if necessary, will be delivered at home.
The participants need to visit the hospital four times, of which at least one
usual care hospital visit. The screening is part of the usual care for
outpatients. We planned three assessment moments in the hospital (week 0, week
4, and week 8), and one assessment moment at home consisting of questionnaires
(week 1). Besides, participants will be asked to keep a simple diary to check
if daily protein goals are achieved and to list the product choice. The
measurement moments in the hospital will last about 60 minutes and consist of
questionnaires to fill in and measurements of body composition and hand grip
strength. To assess urine nitrogen excretion, participants will be asked to
collect 24 hours urine samples at baseline and week 8. This may be a slight
burden for participants.
The benefit of participation in this study, is that participants will receive
individual dietician advice with accompanying products without extra costs. We
expect positive effects of participation on nutritional status, body
composition, and possibly muscle strength. There are no risks associated with
participation. Overall, we think the benefits for the participants will
outweigh the possible burden.