Protein-Energy MalnutritionNCT03712306
The (Cost)Effectiveness of Increasing Protein Intake on Physical Funtioning in Older Adults
A study testing Dietary advice and Dietary advice and advice on timing in people with Protein-Energy Malnutrition and Physical Disability, run by VU University of Amsterdam at 2 sites in 2 countries.
Trial summary
In this RCT with the duration of 6 months among 264 community-dwelling older adults (65+ years) with habitual low protein intake, the investigators will examine the long term (cost) effectiveness of increasing daily protein intake to at least 1.2 gram/kg of adjusted body weight on physical functioning in older adults… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Protein-Energy Malnutrition, Physical Disability
- What is being tested?
- Dietary advice and Dietary advice and advice on timing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 11 Oct 2018to 14 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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 the investigators compare the probability scores of the protein screener with protein intake as measured with food diaries and/or dietary recalls. The investigators will then choose the probability score that is most closely associated with a protein intake < 1.0 g/kg adjusted body weight/day. This probably score reflects older adults with a higher probability on a protein intake < 1.0 g/kg adjusted body weight/d than a general sample of older adults;
Who cannot join
- Inability or unwillingness to provide informed consent
- Not able to eat independently;
- Not able to speak, write and read the Dutch language;
- Current participation to supervised behavioral or lifestyle intervention that intervenes with PROMISS intervention;
- Not able the visit the research site in the following next 6 months;
- Bedridden or wheelchair bound;
Show all 22Show fewer
- Individuals who do not go outside;
- Diagnosed with severe kidney disease;
- Diagnosed with Parkinson's disease;
- Diagnosed with diabetes mellitus type I;
- Diagnosed with diabetes mellitus type 2 and starting with insulin;
- Current treatment of cancer (with the exception of basal cell carcinoma);
- Vegan diet;
- Severe allergies to certain food products (such as peanuts, gluten);
- Diagnosed with an eating disorder (self-reported);
- Purposefully lost/gained > 3 kg in the past three months
- Heart problems in the past three months (heart attack, angioplasty, heart surgery, stroke or other serious heart disease)
- Not able to complete the 400 meter walk test within 15 minutes (self-reported, and assessed at study baseline).
- Alcohol abuse past 6 months (AUDIT-C ≥ 2);
- Low cognitive status, defined as the mini-mental state examination (MMSE) score ≤ 20
- 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);
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Netherlands1 site
Vrije Universiteit Amsterdam
Amsterdam, North Holland, 1081 HV
About this study
Official title: The (Cost) Effectiveness of Increasing Daily Protein Intake to 1.2 Gram Per Kilo Body Weight on Physical Functioning in Community-dwelling Older Adults With a Habitual Daily Protein Intake < 1.0 Gram Per Kilo Body Weight
In this RCT with the duration of 6 months among 264 community-dwelling older adults (65+ years) with habitual low protein intake, the investigators will examine the long term (cost) effectiveness of increasing daily protein intake to at least 1.2 gram/kg of adjusted body weight on physical functioning in older adults with low protein intake.
Read the detailed description
In this RCT with the duration of 6 months the investigators will examine the long term (cost) effectiveness of increasing protein intake to at least 1.2 g/kg adjusted body weight/d on physical functioning in older adults with habitual low protein intake. Additionally, the investigators will examine the combined effect of increasing protein intake to at least 1.2 g/kg adjusted body weight/d and consuming protein in close proximity with regular physical activity on physical functioning in older adults with habitual low protein intake.
Three sub-studies will be conducted, of which the main objectives are to:
- Examine the effect of persuasive technology on adherence to consumption of protein rich food products in order to increase protein intake to at least 1.2 g/kg adjusted body weight/d, and to the combination of increasing protein intake to at least 1.2 g/kg adjusted body weight/d and consuming protein in close proximity with regular physical activity.
- Examine the effect of increasing protein intake to at least 1.2 g/kg adjusted body weight/d on faecal and oral microbiota composition in older adults with a habitual low protein intake.
- Examine the effects of increasing protein intake to at least 1.2 g/kg adjusted body weight/d on food-stimuli related central nervous system satiety and reward responses involved in the regulation of food intake, measured by functional magnetic resonance imaging in older adults with a habitual low protein intake. Study design: Randomized controlled trial with the duration of 6 months in two study sites: Amsterdam, the Netherlands and Helsinki, Finland. Stratification by gender and habitual protein intake (low protein (>=0.9 g/kg BW/day - <1.0 g/kg BW/day), very low protein (<0.9 g/kg BW/day)). Study population: A total of 264 community-dwelling older adults aged ≥ 65 years with an habitual low protein intake (n=132 at each study site). 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 at least 1.2 g/kg adjusted 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. Main study parameters/endpoints: The primary outcome of this study is change in walk time on the 400 meter walk test. 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. Statistical analyses: The collected data at the two study sites will be pooled together. As a result of randomization at study baseline, we assume that groups are equal regarding demographical and socio-economic variables. If this is not the case, we will adjust for differences between groups at baseline. We will adjust for study site (the Netherlands, Finland) and baseline outcome values. We will present unadjusted and adjusted results. The main analyses will be based on intention-to-treat principles, but per-protocol analyses will also be conducted as a sensitivity analysis. Multiple Imputation (MI) using multivariate Imputation by Chained Equations (MICE) will be used to impute missing cost and effect data. For this, the missing values need to be missing at random. The (cost) effectiveness of two intervention groups will be examined against the control group on the primary outcome walk time on the 400 meter walk test. We will compare outcomes between the respective intervention groups and control group separately to determine whether the two interventions are effective (group 1 versus control group; group 2 versus control group). We will perform mixed model regression analyses adjusting for confounding variables at baseline and study site as cluster variable. We will not correct for multiple testing but look at the clinical relevance of the outcome. In addition, we will perform sensitivity analyses leaving out the participants who took part in the persuasive technology sub-study. ** Update June 2020 ** Deviation of the protocol Due to the worldwide spread of Covid-19, the original protocol of the PROMISS prevention trial has been changed for those participants who were still active in the study during the spread (March 16th - June 1st). In consultation with both Medical Ethical boards from Finland and the Netherlands, and PROMISS' ethical advisor, the following changes were applied: March 2020 * Starting from March 16 2020, the final follow-up measurement of 80 participants (out of 276) was postponed until further notice.
- Participants were informed that they would be invited for the final follow-up measurement when the country-specific governmental regulations allowed it.
- Participants were requested to stick to their habitual diet (control group) or their intervention diet (both intervention groups). April 2020 * Final measurements were resumed (through interview by phone) except for the physical measurements.
- Dietary intake was assessed in the week prior to the phone call measurement.
- Self-reported body weight was added to the questionnaire.
- The physical follow-up measurement was still postponed until further notice. May 2020
- Data collection was continued by means of questionnaires during the phone call measurement in both Finland and the Netherlands. June 2020
- Starting from the beginning of June, the physical measurements at the clinic site were also resumed in both Finland and the Netherlands. Those with no health complaints potentially caused by the coronavirus were allowed to visit the clinic site.
- The data collection will finish by July 31, 2020. We will perform sensitivity analyses excluding those participants who were still active in the study during the spread and thus had their physical follow-up measurement +/- 8 months after the baseline assessment (instead of 6 months).
- Conditions
- Protein-Energy Malnutrition, Physical Disability
- Being tested
- Dietary advice, Dietary advice and advice on timing
- Medical subject headings
- Protein-Energy Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary adviceOther
Dietary advice to increase protein intake to at least 1.2 g/kg adjusted body weight/d
Dietary advice and advice on timingOther
Dietary advice to increase protein intake to at least 1.2 g/kg adjusted body weight/d plus advice on consuming protein in close proximity of usual physical activity
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | No intervention. Participants will only receive a brochure on general healthy eating habits. |
| Dietary advice | Experimental | Personalized nutritional advice from a registered dietician or nutritionist aimed at increasing protein intake to at least 1.2 g/kg adjusted body weight/d, through intake of regular protein rich food products and provided protein-enriched food products. Receives: Other: Dietary advice |
| Dietary advice and advice on timing | Experimental | Personalized nutritional advice from a registered dietician or nutritionist aimed at increasing protein intake to at least 1.2 g/kg adjusted body weight/d, through intake of regular protein rich food products and provided protein-enriched food products, as well as advice regarding the consumption of protein rich food products in close proximity of usual physical activity. Receives: Other: Dietary advice and advice on timing |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month change in walk time on a 400 meter walk test
Change in walk time on a 400 meter walk test
Measured: 6 months
Secondary outcomes (15)
6-months change in Physical performance assessed by the Short Physical Performance Battery (SPPB)
SPPB consists of three tests: repeated chair stands test, 4 meter walk test, and tandem stand test. The total score ranges from 0-12. A higher score indicates better physical functioning.
Measured: 6 months
6-month change in hand grip strength
Hand grip strength measured by a hand held dynamometer
Measured: 6 months
6-month change in leg strength
Upper leg strength measured by a measurement chair
Measured: 6 months
6-month change in body composition
Body composition (fat-free mass, skeletal muscle mass and fat mass) will be assessed from bioelectrical impedance using body resistance, reactance, impedance and phase angle. In the Dutch sample only, fat-free mass and fat mass will be directly measured by using densitometry (BODPOD).
Measured: 6 months
3, and 6-moths self-reported mobility limitations (questionnaire)
Mobility limitations will be assessed by means of a questionnaire; "Because of your health, how much difficulty do you have walking 400 meter?" and "Because of your health, how much difficulty do you have climbing one flight of stairs?" Participants responded using a five level Likert scale: 'No difficulty', 'a little difficulty', 'some difficulty', 'a lot of difficulty', and 'unable to do the activity'.
Measured: 3 and 6 months
3, and 6-moths self perceived quality of life
Quality of life measured using the EuroQol-5D instrument. The EuroQol 5D consists of five questions on a Likert scale (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Answer categories range from (1) 'no problems' to (5) 'unable to'. An additional thermometer for experienced health is scored on a Visual Analogue scale (VAS), ranging from 0-100. The exact point where the line crosses the VAS is the VAS score. The scores are converted to an index value, which facilitates the calculation of quality-adjusted life years (QALYs) that is used to calculate the cost-effectiveness of the study.
Measured: 3 and 6 months
Incident frailty assessed by the Fried Frailty Index
Frailty will be determined using the 5 criteria of the Fried Frailty Index:
- Self-reported unintentional weight loss: >4 kg in past 6 months.
- Self-reported exhaustion. Based on two self-reported questions from the Center for Epidemiologic Studies Depression scale on exhaustion in the past week at baseline and follow-up: "I felt that everything I did was an effort" and "I could not get going". Scores ranges from 1 'not at all' to 4 'most of the time'. A score of 3 or 4 on either question indicates exhaustion.
- Weakness: grip strength in the lowest 20% of the study population, adjusted for gender and BMI.
- Slow walking speed: walk time on the 400 meter walk test in the slowest 20% of the study population, adjusted for gender and height.
- Low physical activity: Kilocalories expended/wk based on accelerometer data in the lowest quintile of physical activity for each gender.
Outcome:
No components:robust
1 or 2 components:intermediate/prefrail 3 or more components:frail
Measured: 6 months
Incidence of sarcopenia risk
Incidence of sarcopenia risk will be assessed with the SARC-F questionnaire; how much effort do you experience when 1) lifting and carrying a bag of 4.5 kilo, 2) walking across a room, 3) transferring from a chair or bed, 4) climbing a flight of 10 stairs, and 5) how many times have you fallen in the past year. Answering option include no effort (0 points), a bit of effort (1 point) and a lot of effort (2 points), where a score equal to or greater than 4 is predictive of sarcopenia and poor outcomes.
Measured: 3 and 6 months
Incident malnutrition
BMI<22 kg/m2 and unintentional weight loss >5% over 6 months
Measured: 6 months
3, and 6-moths health care costs assessed by questionnaire
To measure health care costs the investigators will use a modified version of the Resource Utilization in Dementia Questionnaire WIMO. This questionnaire contains questions on hospital admissions, prescribed medicine use, care from health professionals, and use of other health care services in the past three months. These are the domains that the investigators might expect changes in due to the intervention.
Measured: 3 and 6 months
3, and 6-month change in body weight
Body weight (kg) will be measured to the nearest 0,1 kg using a calibrated scale.
Measured: 3 and 6 months
Body height
Body height (cm) will be measured to the nearest 0.1 cm using a stadiometer.
Measured: baseline
3, and 6-month change in body mass index (BMI)
Based on measured weight (measured at baseline and after 6 months) and height (measured at baseline) BMI will be calculated as body weight (kg) divided by height (m) squared.
Measured: 3 and 6 months
Dietary intake assesed by three 24-hour recalls
A 24-hour recall is a structured interview intended to capture detailed information about all foods and beverages consumed by the participant in the past 24 hours. Changes in dietary intake (based on data of the 24-hour recalls) enables to investigate compliance; i.e. higher protein intake indicates higher compliance.
Measured: 3 and 6 months
Physical activity
Physical activity will be objectively assessed by means of an accelerometer (Axivity, AX3) during 7 subsequent days after each clinic visit.
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start11 Oct 2018
- Primary completion31 Jul 2020
- Study completion14 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Protein-Energy MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized intro one of the three study groups. Stratification by gender and habitual protein intake (low protein (\>=0.9 g/kg aBW/day - \<1.0 g/kg aBW/day), very low protein (\<0.9 g/kg aBW/day)), since we expect a different intervention effect for participants with a very low baseline habitual protein intake (\< 0.9 g/kg aBW/d) compared to participants with a low baseline habitual protein intake (≥ 0.9 g/kg aBW/d), and because of potential differences in how women and men respond to the intervention. In case couples participate, we will make sure they will be allocated to the same intervention group. This will ensure no interference between intervention groups. We will randomly select whether the randomization for the intervention group is based on the men or the women.
- Masking
- None (open label)
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- VU University of Amsterdam
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki, Amsterdam UMC, location VUmc
- Responsible party
- Principal investigator, Ilse Reinders, VU University of Amsterdam
- Investigators
- Marjolein Visser, Prof., PhD, Study chair, VU University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712306
- Sponsor's protocol ID
- 678732
- Status last verified
- Sep 2020
- First submitted
- 2 Jul 2018
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Grasso AC, Olthof MR, Reinders I, Wijnhoven HAH, Visser M, Brouwer IA. Effect of personalized dietary advice to increase protein intake on food consumption and the environmental impact of the diet in community-dwelling older adults: results from the PROMISS trial. Eur J Nutr. 2022 Dec;61(8):4015-4026. doi: 10.1007/s00394-022-02896-x. Epub 2022 Jul 5.
PubMed 35788775Reinders I, Visser M, Jyvakorpi SK, Niskanen RT, Bosmans JE, Jornada Ben A, Brouwer IA, Kuijper LD, Olthof MR, Pitkala KH, Vijlbrief R, Suominen MH, Wijnhoven HAH. The cost effectiveness of personalized dietary advice to increase protein intake in older adults with lower habitual protein intake: a randomized controlled trial. Eur J Nutr. 2022 Feb;61(1):505-520. doi: 10.1007/s00394-021-02675-0. Epub 2021 Oct 5.
PubMed 34609621Reinders I, Wijnhoven HAH, Jyvakorpi SK, Suominen MH, Niskanen R, Bosmans JE, Brouwer IA, Fluitman KS, Klein MCA, Kuijper LD, van der Lubbe LM, Olthof MR, Pitkala KH, Vijlbrief R, Visser M. Effectiveness and cost-effectiveness of personalised dietary advice aiming at increasing protein intake on physical functioning in community-dwelling older adults with lower habitual protein intake: rationale and design of the PROMISS randomised controlled trial. BMJ Open. 2020 Nov 20;10(11):e040637. doi: 10.1136/bmjopen-2020-040637.
PubMed 33444206
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The (Cost) Effectiveness of Increasing Daily Protein Intake to 1.2 Gram Per Kilo Body Weight on Physical Functioning in Community-dwelling Older Adults With a Habitual Daily Protein Intake < 1.0 Gram Per Kilo Body Weight
- ClinicalTrials.gov ID
- NCT03712306
- Acronym / sponsor ID
- 678732
- Conditions
- Protein-Energy Malnutrition, Physical Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- VU University of AmsterdamUniversity, hospital or other
- Collaborators
- University of Helsinki, Amsterdam UMC, location VUmc
- Study start
- 11 Oct 2018 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 14 Aug 2020 (actual)
- First posted
- 19 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this RCT with the duration of 6 months among 264 community-dwelling older adults (65+ years) with habitual low protein intake, the investigators will examine the long term (cost) effectiveness of increasing daily protein intake to at least 1.2 gram/kg of adjusted body weight on physical functioning in older adults with low protein intake.
Detailed description
In this RCT with the duration of 6 months the investigators will examine the long term (cost) effectiveness of increasing protein intake to at least 1.2 g/kg adjusted body weight/d on physical functioning in older adults with habitual low protein intake. Additionally, the investigators will examine the combined effect of increasing protein intake to at least 1.2 g/kg adjusted body weight/d and consuming protein in close proximity with regular physical activity on physical functioning in older adults with habitual low protein intake.
Three sub-studies will be conducted, of which the main objectives are to:
- Examine the effect of persuasive technology on adherence to consumption of protein rich food products in order to increase protein intake to at least 1.2 g/kg adjusted body weight/d, and to the combination of increasing protein intake to at least 1.2 g/kg adjusted body weight/d and consuming protein in close proximity with regular physical activity.
- Examine the effect of increasing protein intake to at least 1.2 g/kg adjusted body weight/d on faecal and oral microbiota composition in older adults with a habitual low protein intake.
- Examine the effects of increasing protein intake to at least 1.2 g/kg adjusted body weight/d on food-stimuli related central nervous system satiety and reward responses involved in the regulation of food intake, measured by functional magnetic resonance imaging in older adults with a habitual low protein intake. Study design: Randomized controlled trial with the duration of 6 months in two study sites: Amsterdam, the Netherlands and Helsinki, Finland. Stratification by gender and habitual protein intake (low protein (>=0.9 g/kg BW/day - <1.0 g/kg BW/day), very low protein (<0.9 g/kg BW/day)). Study population: A total of 264 community-dwelling older adults aged ≥ 65 years with an habitual low protein intake (n=132 at each study site). 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 at least 1.2 g/kg adjusted 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. Main study parameters/endpoints: The primary outcome of this study is change in walk time on the 400 meter walk test. 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. Statistical analyses: The collected data at the two study sites will be pooled together. As a result of randomization at study baseline, we assume that groups are equal regarding demographical and socio-economic variables. If this is not the case, we will adjust for differences between groups at baseline. We will adjust for study site (the Netherlands, Finland) and baseline outcome values. We will present unadjusted and adjusted results. The main analyses will be based on intention-to-treat principles, but per-protocol analyses will also be conducted as a sensitivity analysis. Multiple Imputation (MI) using multivariate Imputation by Chained Equations (MICE) will be used to impute missing cost and effect data. For this, the missing values need to be missing at random. The (cost) effectiveness of two intervention groups will be examined against the control group on the primary outcome walk time on the 400 meter walk test. We will compare outcomes between the respective intervention groups and control group separately to determine whether the two interventions are effective (group 1 versus control group; group 2 versus control group). We will perform mixed model regression analyses adjusting for confounding variables at baseline and study site as cluster variable. We will not correct for multiple testing but look at the clinical relevance of the outcome. In addition, we will perform sensitivity analyses leaving out the participants who took part in the persuasive technology sub-study. ** Update June 2020 ** Deviation of the protocol Due to the worldwide spread of Covid-19, the original protocol of the PROMISS prevention trial has been changed for those participants who were still active in the study during the spread (March 16th - June 1st). In consultation with both Medical Ethical boards from Finland and the Netherlands, and PROMISS' ethical advisor, the following changes were applied: March 2020 * Starting from March 16 2020, the final follow-up measurement of 80 participants (out of 276) was postponed until further notice.
- Participants were informed that they would be invited for the final follow-up measurement when the country-specific governmental regulations allowed it.
- Participants were requested to stick to their habitual diet (control group) or their intervention diet (both intervention groups). April 2020 * Final measurements were resumed (through interview by phone) except for the physical measurements.
- Dietary intake was assessed in the week prior to the phone call measurement.
- Self-reported body weight was added to the questionnaire.
- The physical follow-up measurement was still postponed until further notice. May 2020
- Data collection was continued by means of questionnaires during the phone call measurement in both Finland and the Netherlands. June 2020
- Starting from the beginning of June, the physical measurements at the clinic site were also resumed in both Finland and the Netherlands. Those with no health complaints potentially caused by the coronavirus were allowed to visit the clinic site.
- The data collection will finish by July 31, 2020. We will perform sensitivity analyses excluding those participants who were still active in the study during the spread and thus had their physical follow-up measurement +/- 8 months after the baseline assessment (instead of 6 months).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomized intro one of the three study groups. Stratification by gender and habitual protein intake (low protein (>=0.9 g/kg aBW/day - <1.0 g/kg aBW/day), very low protein (<0.9 g/kg aBW/day)), since we expect a different intervention effect for participants with a very low baseline habitual protein intake (< 0.9 g/kg aBW/d) compared to participants with a low baseline habitual protein intake (≥ 0.9 g/kg aBW/d), and because of potential differences in how women and men respond to the intervention. In case couples participate, we will make sure they will be allocated to the same intervention group. This will ensure no interference between intervention groups. We will randomly select whether the randomization for the intervention group is based on the men or the women.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –No intervention. Participants will only receive a brochure on general healthy eating habits. |
| Dietary advice | Experimental | Other: Dietary advicePersonalized nutritional advice from a registered dietician or nutritionist aimed at increasing protein intake to at least 1.2 g/kg adjusted body weight/d, through intake of regular protein rich food products and provided protein-enriched food products. |
| Dietary advice and advice on timing | Experimental | Other: Dietary advice and advice on timingPersonalized nutritional advice from a registered dietician or nutritionist aimed at increasing protein intake to at least 1.2 g/kg adjusted body weight/d, through intake of regular protein rich food products and provided protein-enriched food products, as well as advice regarding the consumption of protein rich food products in close proximity of usual physical activity. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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 the investigators compare the probability scores of the protein screener with protein intake as measured with food diaries and/or dietary recalls. The investigators will then choose the probability score that is most closely associated with a protein intake < 1.0 g/kg adjusted body weight/day. This probably score reflects older adults with a higher probability on a protein intake < 1.0 g/kg adjusted body weight/d than a general sample of older adults;
Key exclusion criteria (22 listed)
- Inability or unwillingness to provide informed consent
- Not able to eat independently;
- Not able to speak, write and read the Dutch language;
- Current participation to supervised behavioral or lifestyle intervention that intervenes with PROMISS intervention;
- Not able the visit the research site in the following next 6 months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary adviceDietary advice to increase protein intake to at least 1.2 g/kg adjusted body weight/d | Other | Dietary advice |
| Dietary advice and advice on timingDietary advice to increase protein intake to at least 1.2 g/kg adjusted body weight/d plus advice on consuming protein in close proximity of usual physical activity | Other | Dietary advice and advice on timing |
Primary outcome
6-month change in walk time on a 400 meter walk test
Time frame: 6 months
Change in walk time on a 400 meter walk test
15 secondary outcomes
6-months change in Physical performance assessed by the Short Physical Performance Battery (SPPB)
Time frame: 6 months
6-month change in hand grip strength
Time frame: 6 months
6-month change in leg strength
Time frame: 6 months
6-month change in body composition
Time frame: 6 months
3, and 6-moths self-reported mobility limitations (questionnaire)
Time frame: 3 and 6 months
3, and 6-moths self perceived quality of life
Time frame: 3 and 6 months
Incident frailty assessed by the Fried Frailty Index
Time frame: 6 months
Incidence of sarcopenia risk
Time frame: 3 and 6 months
Incident malnutrition
Time frame: 6 months
3, and 6-moths health care costs assessed by questionnaire
Time frame: 3 and 6 months
3, and 6-month change in body weight
Time frame: 3 and 6 months
Body height
Time frame: baseline
3, and 6-month change in body mass index (BMI)
Time frame: 3 and 6 months
Dietary intake assesed by three 24-hour recalls
Time frame: 3 and 6 months
Physical activity
Time frame: 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
- Derived from this study: PubMed 35788775Grasso AC, Olthof MR, Reinders I, Wijnhoven HAH, Visser M, Brouwer IA. Effect of personalized dietary advice to increase protein intake on food consumption and the environmental impact of the diet in community-dwelling older adults: results from the PROMISS trial. Eur J Nutr. 2022 Dec;61(8):4015-4026. doi: 10.1007/s00394-022-02896-x. Epub 2022 Jul 5.
- Derived from this study: PubMed 34609621Reinders I, Visser M, Jyvakorpi SK, Niskanen RT, Bosmans JE, Jornada Ben A, Brouwer IA, Kuijper LD, Olthof MR, Pitkala KH, Vijlbrief R, Suominen MH, Wijnhoven HAH. The cost effectiveness of personalized dietary advice to increase protein intake in older adults with lower habitual protein intake: a randomized controlled trial. Eur J Nutr. 2022 Feb;61(1):505-520. doi: 10.1007/s00394-021-02675-0. Epub 2021 Oct 5.
- Derived from this study: PubMed 33444206Reinders I, Wijnhoven HAH, Jyvakorpi SK, Suominen MH, Niskanen R, Bosmans JE, Brouwer IA, Fluitman KS, Klein MCA, Kuijper LD, van der Lubbe LM, Olthof MR, Pitkala KH, Vijlbrief R, Visser M. Effectiveness and cost-effectiveness of personalised dietary advice aiming at increasing protein intake on physical functioning in community-dwelling older adults with lower habitual protein intake: rationale and design of the PROMISS randomised controlled trial. BMJ Open. 2020 Nov 20;10(11):e040637. doi: 10.1136/bmjopen-2020-040637.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marjolein Visser, Prof., PhD study chair
VU University of Amsterdam
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary advice and Dietary advice and advice on timing in people with Protein-Energy Malnutrition and Physical Disability, run by VU University of Amsterdam at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month change in walk time on a 400 meter walk test (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03712306, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2020.