In this RCT with the duration of 6 months we will examine the longterm (cost) effectiveness of increasing protein intake to 1.2 g/kg body weight/d on physical functioning in community-dwelling older adults with a habitual protein intake < 1.0 g/…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Fysiek functioneren
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome of this study is change in walk time on the 400 meter walk
test.
Secondary outcome
Secondary outcomes are change in dietary intake (including macro- and
micronutrients), malnutrition prevalence, physical performance, mobility
limitations, muscle strength, body weight and body composition, frailty status,
quality of life, and health care costs.
Background summary
With the European population growing older, the challenge is to keep an
increasing number of seniors across all European countries healthy and active.
Low protein intake is associated with accelerated loss of lean mass, and an
increased risk of functional impairments in old age. The long term effect of
increasing protein intake to 1.2 g/kg body weight/d on physical functioning in
community-dwelling older adults with habitual low protein intake has hardly
been studied.
Study objective
In this RCT with the duration of 6 months we will examine the longterm (cost)
effectiveness of increasing protein intake to 1.2 g/kg body weight/d on
physical functioning in community-dwelling older adults with a habitual protein
intake < 1.0 g/kg body weight/d. Additionally, we will examine the combined
effect of increasing protein intake to 1.2 g/kg body weight/d and consuming
protein in close proximity with usual physical activity on physical functioning.
Three sub-studies will be conducted, of which the main objectives are to:
1. Examine the effect of persuasive technology on adherence to increasing
protein intake to 1.2 g/kg body weight/d, and to the combination of increasing
protein intake to 1.2 g/kg body weight/d and consuming protein in close
proximity with regular physical activity;
2. Examine the effect of increasing protein intake to 1.2 g/kg body weight/d on
faecal microbiota composition;
3. Examine the effects of increasing protein intake to 1.2 g/kg body weight/d
on food-stimuli related central nervous system (CNS) satiety and reward
responses, measured by functional magnetic resonance imaging (fMRI).
Study design
Randomized controlled trial with the duration of 6 months in two study sites:
Amsterdam, the Netherlands and Helsinki, Finland.
Intervention
This RCT consists of three groups; two intervention groups and one control
group. Intervention group 1 (N=44 at each study site) will receive personalized
dietary advice aimed at increasing protein intake to 1.2 g/kg body weight/d
without changing daily energy intake, by regular foods and by provided
protein-enriched food products. Intervention group 2 (N=44 at each study site)
receives personalized dietary advice similar to group 1 and also receives
personalized advice to consume protein rich foods in close proximity of usual
physical activity. All groups receive a standard brochure of the Netherlands or
Finnish Nutrition Centre with general information about healthy eating habits.
The control group (N=44 at each at each study site) receives no further
intervention.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness:
- Participants in both intervention groups will receive personalized advice
from a registered dietician to increase their protein intake to 1.2 g/kg body
weight/d. In this advice, food preferences and usual food intake are taken into
account. All advice will be energy-neutral to prevent increases or decreases in
body weight. Participants will be requested to adhere to this advice for six
months.
- Participants in intervention group 2 will receive personalized advice from a
registered dietician to increase their protein intake to 1.2 g/kg body weight/d
as well as advice regarding the consumption of protein rich food products in
close proximity of usual physical activity. Participants will be asked to not
change their usual physical activity pattern, but only adjust the timing of the
consumption of protein rich food and physical activity.
- Participants in both intervention groups will receive protein-enriched food
products for free. The contents of the provided protein-enriched food products
will be similar to that available in over-the-counter products, thereby
presenting no health risks to the participants.
- Participants in the control group will receive a standard brochure of the
Netherlands Nutrition Centre with general information about healthy eating
habits and a present.
- All participants will be invited to different lectures on topics that are not
related to food intake.
- Measurements will take place at baseline, mid-study (3 months) and follow-up
(6 months) at the university. This will involve 1.5 hour assessments.
- Physical activity will be measured seven days at baseline, mid-study and
follow-up by means of an accelerometer.
- Food intake will be measured three days at baseline, mid-study and follow-up
by means of dietary recalls supported by food diaries.
- Participants from the intervention groups will have an extra appointment at
the university where they will receive a personalized high-protein diet advice
and protein-enriched food products at study baseline and at mid-study.
- During the study, we will call all participants frequently to ask for any
experienced difficulties with the intervention and provide additional
(nutritional) advice if needed. Participants can contact us by mail or
telephone at any time during the study.
- In the persuasive technology sub-study conducted in a Dutch sub-sample of
participants of the intervention groups (n=24 per intervention group),
participants will receive a food storage box that can measure which protein
rich food products are taken out and a small-size screen (tablet) that provides
reminders and nudges. We will test if there are differences in adherence to the
interventions between participants who took part in this sub-study and
participants who did not.
- In the microbiota sub-study (as many subjects as possible) conducted in a
Dutch sub-sample of participants from the control group and intervention group
1 (increasing protein intake to 1.2 g/kg body weight/d), tongue swabs and
faecal samples will be collected at baseline and follow-up to determine the
effect of a long term high-protein dietary intervention on faecal and oral
microbiota. Participants will receive a ¤20,- VVV-gift card for participating
in this part of the study.
- In the fMRI sub-study conducted in a sub-sample of the Dutch participants
that also participate in the microbiota sub-study (control group and
intervention group 1) (n=25), blood samples will be drawn and participants will
take part in a functional magnetic resonance imaging (fMRI) measurement at
baseline and follow-up to determine the effects increasing protein intake to to
1.2 g/kg body weight/d on food-stimuli related central nervous system (CNS)
satiety and reward responses. Participants will receive an addition of a ¤80,-
VVV-gift card for participating in this part of the study.
De Boelelaan 1085
Amsterdam 1081 HV
NL
De Boelelaan 1085
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
- Age * 65 years;
- Community-dwelling;
- Lower protein intake defined as both a probability score above a certain cutoff on the protein screener (www.proteinscreener.nl) as well as based on actual protein intake assessed by 24-hour recalls. The protein screener was developed and validated using an extended FFQ among Dutch older adults. The cutoff will be chosen based on results of different studies in which we compare the probability scores of the protein screener with protein intake as measured with food diaries and/or dietary recalls. We will then choose the probability score that is most closely associated with a protein intake < 1.0 g/kg body weight/day. This probably score reflects older adults with a higher probability on a protein intake < 1.0 g/kg body weight/d than a general sample of older adults;
- Able to eat independently;
- Willing to eat our provided protein-enriched food products and change food habits;
- Able to speak, write and read the Dutch language;
- Able to walk 400 meter, with or without the help of a walking cane (self-reported).
Exclusion criteria
- Bedridden or wheelchair bound;
- Individuals who do not go outside;
- Individuals with bad hearing (who cannot hear without a hearing aid);
- Diagnosed with diabetes mellitus type I;
- Diagnosed with diabetes mellitus type 2 and starting with insulin;
- Diagnosed with severe kidney disease;
- Diagnosed with Parkinson*s disease;
- Current treatment of cancer (with the exception of basal cell carcinoma);
- BMI < 18.5 kg/m2 (self-reported, and assessed at study baseline);
- Overweight, defined as BMI > 32.0 kg/m2 (self-reported, and assessed at study baseline);
- Vegan;
- Allergies to certain food products (such as peanuts, gluten);
- Alcohol abuse past 6 months (AUDIT-C * 2);
- Diagnosed with an eating disorder (self-reported);
- Current participation to supervised behavioral or lifestyle intervention that intervenes with PROMISS intervention;
- Planning to move out of the study area in the next 6 months;
- Actively trying to lose or gain weight;
- Not able to complete the 400 meter walk test (self-reported, and assessed at study baseline).
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| Other | ClinicalTrials.gov [not yet assigned] - Release Date: July 2nd, 2018 |
| CCMO | NL65484.029.18 |