Physical Disability Clinical Trial
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
NCT number | NCT03712306 |
Other study ID # | 678732 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 11, 2018 |
Est. completion date | August 14, 2020 |
Verified date | September 2020 |
Source | VU University of Amsterdam |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 276 |
Est. completion date | August 14, 2020 |
Est. primary completion date | July 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years and older |
Eligibility |
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 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; Exclusion criteria: - 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; - 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); |
Country | Name | City | State |
---|---|---|---|
Finland | University of Helsinki | Helsinki | |
Netherlands | Vrije Universiteit Amsterdam | Amsterdam | Noord Holland |
Lead Sponsor | Collaborator |
---|---|
VU University of Amsterdam | University of Helsinki, VU University Medical Center |
Finland, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Effectiveness of persuasive technology sub-study on protein intake | Examine the effect of persuasive technology on adherence to increasing protein intake. A subsample of the Dutch 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. The investigators 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. | 6 months | |
Other | Microbiota sub-study | The effect of increasing protein intake to at least 1.2 g/kg body weight/d on faecal and oral microbiota composition | 6 months | |
Other | Effect of protein intake on satiety and reward responses measured by functional magnetic resonance imaging | To examine the effects of increasing protein intake on food-stimuli related central nervous system satiety and reward responses involved in the regulation of food intake, measured by functional magnetic resonance imaging. BOLD fMRI will be used to measure neuronal activity in CNS satiety and reward circuits (including striatum, amygdala, orbitofrontal cortex, insula) in response to visual food stimuli (pictures of food items) and to the actual consumption of food (chocolate milk). |
6 months | |
Primary | 6-month change in walk time on a 400 meter walk test | Change in walk time on a 400 meter walk test | 6 months | |
Secondary | 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. | 6 months | |
Secondary | 6-month change in hand grip strength | Hand grip strength measured by a hand held dynamometer | 6 months | |
Secondary | 6-month change in leg strength | Upper leg strength measured by a measurement chair | 6 months | |
Secondary | 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). | 6 months | |
Secondary | 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'. | 3 and 6 months | |
Secondary | 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. | 3 and 6 months | |
Secondary | 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 |
6 months | |
Secondary | 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. | 3 and 6 months | |
Secondary | Incident malnutrition | BMI<22 kg/m2 and unintentional weight loss >5% over 6 months | 6 months | |
Secondary | 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. | 3 and 6 months | |
Secondary | 3, and 6-month change in body weight | Body weight (kg) will be measured to the nearest 0,1 kg using a calibrated scale. | 3 and 6 months | |
Secondary | Body height | Body height (cm) will be measured to the nearest 0.1 cm using a stadiometer. | baseline | |
Secondary | 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. | 3 and 6 months | |
Secondary | 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. | 3 and 6 months | |
Secondary | Physical activity | Physical activity will be objectively assessed by means of an accelerometer (Axivity, AX3) during 7 subsequent days after each clinic visit. | 3 and 6 months |
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