Developed by Shray Alag, The Harker School
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There is one clinical trial.
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.
Description: Change in walk time on a 400 meter walk test
Measure: 6-month change in walk time on a 400 meter walk test Time: 6 monthsDescription: 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.
Measure: 6-months change in Physical performance assessed by the Short Physical Performance Battery (SPPB) Time: 6 monthsDescription: Hand grip strength measured by a hand held dynamometer
Measure: 6-month change in hand grip strength Time: 6 monthsDescription: Upper leg strength measured by a measurement chair
Measure: 6-month change in leg strength Time: 6 monthsDescription: 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).
Measure: 6-month change in body composition Time: 6 monthsDescription: 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'.
Measure: 3, and 6-moths self-reported mobility limitations (questionnaire) Time: 3 and 6 monthsDescription: 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.
Measure: 3, and 6-moths self perceived quality of life Time: 3 and 6 monthsDescription: 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
Measure: Incident frailty assessed by the Fried Frailty Index Time: 6 monthsDescription: 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.
Measure: Incidence of sarcopenia risk Time: 3 and 6 monthsDescription: BMI<22 kg/m2 and unintentional weight loss >5% over 6 months
Measure: Incident malnutrition Time: 6 monthsDescription: 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.
Measure: 3, and 6-moths health care costs assessed by questionnaire Time: 3 and 6 monthsDescription: Body weight (kg) will be measured to the nearest 0,1 kg using a calibrated scale.
Measure: 3, and 6-month change in body weight Time: 3 and 6 monthsDescription: Body height (cm) will be measured to the nearest 0.1 cm using a stadiometer.
Measure: Body height Time: baselineDescription: 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.
Measure: 3, and 6-month change in body mass index (BMI) Time: 3 and 6 monthsDescription: 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.
Measure: Dietary intake assesed by three 24-hour recalls Time: 3 and 6 monthsDescription: Physical activity will be objectively assessed by means of an accelerometer (Axivity, AX3) during 7 subsequent days after each clinic visit.
Measure: Physical activity Time: 3 and 6 monthsDescription: 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.
Measure: Effectiveness of persuasive technology sub-study on protein intake Time: 6 monthsDescription: The effect of increasing protein intake to at least 1.2 g/kg body weight/d on faecal and oral microbiota composition
Measure: Microbiota sub-study Time: 6 monthsDescription: 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).
Measure: Effect of protein intake on satiety and reward responses measured by functional magnetic resonance imaging Time: 6 monthsAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
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