To study the effectiveness of protein-enriched meals and bread in increasing daily protein intake with at least 14.5g among in-home assisted community-dwelling older adults, in order to reach the daily protein recommendation of 1.2g per kg…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Voldoen aan eiwitbehoefte van ouderen ter voorkoming van ondervoeding.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Our main parameter of interest is total daily protein intake throughout three
weeks.
Secondary outcome
Our secondary study parameters are total daily nutritional intake and product
evaluation throughout three weeks.
Background summary
Undernutrition risk among community-dwelling older adults in developed
countries is shown to be as high as 24%, making the aging process unpleasant
for many around the world. The main cause of undernutrition was found to be
protein-energy wasting among older adults. This wasting is mainly induced by
three processes: a reduced capacity to exploit proteins because of impaired
anabolic and insulin responses, an increased physiological need for proteins
due to a lifelong cumulative physical decline, and a reduced energy and protein
intake. Counteracting the reduced protein intake is a strategy that is feasible
as well as efficacious to reduce undernutrition in community-dwelling older
adults. A promising strategy to increase protein intake among older adults, is
to offer solutions that are close to their current daily eating patterns.
Study objective
To study the effectiveness of protein-enriched meals and bread in increasing
daily protein intake with at least 14.5g among in-home assisted
community-dwelling older adults, in order to reach the daily protein
recommendation of 1.2g per kg bodyweight per day. In addition, to study
longer-term liking of protein-enriched meals and bread among in-home assisted
community-dwelling older adults.
Study design
The study will be performed as a double-blind, randomized, controlled,
three-week trial in a real life setting, with one control and one intervention
group.
Intervention
The control group will receive ten standard meals and ad libitum standard bread
during two weeks within a total trial period of three weeks. The intervention
group will receive ten protein-enriched meals and ad libitum protein-enriched
bread during two weeks within a total trial period of three weeks.
Study burden and risks
The risks associated with participation can be considered negligible and the
burden can be considered minimal. Firstly, the interventional products that we
apply are expected to be beneficial for the residents. Secondly, normal food
products are used that are produced by food companies, with the use of regular
ingredients. Consequently, the regular hygienic and food safety criteria are
valid during their production, as the meals and bread are food-grade produced
and tested according to the food safety regulations. Therefore, we do not
expect any potential risks regarding the products themselves. Thirdly, no
invasive measurements will be performed. By a respectful approach, the
questions with regard to items eaten during the day may even be perceived as a
pleasant social activity. In addition, participants receive meals and bread
during two weeks, which yields time because participants do not have to cook
and have less groceries to do. This study is group related, since there is no
use in testing longer-term acceptability and intake protein-enriched ready
meals and bread without participation of the ultimate target group, in-home
assisted community-dwelling older adults.
Bornse Weilanden 9
Wageningen 6708 WG
NL
Bornse Weilanden 9
Wageningen 6708 WG
NL
Listed location countries
Age
Inclusion criteria
- Aged 65 years or over;
- Living independently in a residential care centre;
- Being able to choose their food by themselves;
- Being able to eat by themselves;
- Being able to understand Dutch;
- Having signed informed consent.
Exclusion criteria
- Legally incapacitated;
- Unwilling to give permission to contact their GP regarding their eligibility;
- Mini Mental State Examination score <24;
- Not liking whole wheat bread or not liking at least five of the eight offered meals;
- Having an allergy/intolerance for milk, lactose, soy, or gluten;
- Following a diet that does not allow the use of normal bread or meals (e.g. fluid diet, strong sodium restricted diet);
- Suffering from renal insufficiency (eGFR < 60 ml/min);
- Suffering from a terminal illness.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL52857.081.15 |