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Report for D011502: Protein-Energy Malnutrition NIH

(Synonyms: Protein-Energy Malnutrition)

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)


Name (Synonyms) Correlation
drug766 Dietary advice and advice on timing Wiki 1.00
drug765 Dietary advice Wiki 1.00

Correlated MeSH Terms (1)


Name (Synonyms) Correlation
D044342 Malnutrition NIH 0.58

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0004395 Malnutrition HPO 0.58

There is one clinical trial.

Clinical Trials


1 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.

NCT03712306 Protein-Energy Malnutrition Physical Disability Other: Dietary advice Other: Dietary advice and advice on timing
MeSH:Malnutrition Protein-Energy Malnutrition
HPO:Malnutrition

Primary Outcomes

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 months

Secondary Outcomes

Description: 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 months

Description: BMI<22 kg/m2 and unintentional weight loss >5% over 6 months

Measure: Malnutrition incidence

Time: 6 months

Description: 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 months

Description: 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 months

Description: Hand grip strength measured by a hand held dynamometer

Measure: 6-month change in hand grip strength

Time: 6 months

Description: Upper leg strength measured by a measurement chair

Measure: 6-month change in leg strength

Time: 6 months

Description: 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 months

Description: Body height (cm) will be measured to the nearest 0.1 cm using a stadiometer.

Measure: Body height

Time: baseline

Description: 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 months

Description: 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 months

Description: 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: Frailty assessed by the Fried Frailty Index

Time: 6 months

Description: 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 months

Description: 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 months

Other Outcomes

Description: 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 months

Description: 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 months

Description: 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 months


HPO Nodes