Covid 19 Research using Clinical Trials (Home Page)
Report for D044342: Malnutrition NIH
(Synonyms: Malnut, Malnutr, Malnutri, Malnutrit, Malnutriti, Malnutrition)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (3)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug311 | Back Side of the Moon Wiki | 0.58 |
| drug766 | Dietary advice and advice on timing Wiki | 0.58 |
| drug765 | Dietary advice Wiki | 0.58 |
There are 3 clinical trials
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
2 Back Side of the Moon Study: What is the Efficiency of Nutritional Therapy (Calories and Nitrogen) in ICU and on the Ward and What is the Metabolic Profile of Patients After ICU? Could Supplemental Nutrition Fill the Gap?
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 monthsSecondary 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 monthsDescription: BMI<22 kg/m2 and unintentional weight loss >5% over 6 months
Measure: Malnutrition incidence 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: 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: 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 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: 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: 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 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: 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 monthsOther 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 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 monthsProspective observational follow-up of Intensive Care Unit (ICU) survivors on the adequacy of nutritional therapy: what is the mean caloric and nitrogen intake and how does their metabolic profile evolve over time? Is supplemental nutrition, in any forms, indicated to fill the caloric and protein gap? Would IV access be a barrier for SPN, and would subcutaneous parenteral nutrition be welcomed by health care practitioners and patients? Are patient centered outcomes (physical function, quality of life, performance in activities of daily living) correlated with nutritional adequacy and metabolic profile? Overall: are ICU survivors well fed after they leave ICU until hospital discharge? What kind of nutrition would possibly be useful to optimize the intake? How do their energy and protein requirements evolve? What is the physical and mental status of ICU survivors and is this correlated with nutritional status?
NCT03724045 Nutritional Deficiency Hospitalism Dietary Supplement: Back Side of the Moon MeSH:Malnutrition
HPO:Malnutrition
Primary Outcomes
Description: Morbidity
Measure: Morbidity Time: 6 months after hospital discharge
Secondary Outcomes
Description: Mortality
Measure: Mortality Time: 6 months after hospital discharge
3 Covid-19 and Prevention of Malnutrition After Confinement by Dentists: Prospective Study Among 100 Adults Received in Dental Consultation at Nice University Hospital and Sent to Their Physician for Assessment and Nutritional Care
Primary Outcomes
Description: Morbidity
Measure: Morbidity Time: 6 months after hospital dischargeSecondary Outcomes
Description: Mortality
Measure: Mortality Time: 6 months after hospital dischargeBackground. The Covid-19 pandemic reached France in January 2020 and the French government decreed the confinement of the population for eight weeks, from March 17 to May 10, 2020. Dental surgeries were closed and only dental emergency services were provided. Dental surgeries reopened on May 11th, with a limited focus on urgent care, by applying new occupational hygiene standards to limit the circulation of SARS-Cov-2 coronavirus. Hypothesis. From May 11th, chronic patients and elderly patients who come to the hospital for dental consultations will have two risks of malnutrition:
NCT04386460 Nutrition Poor Infection Viral Oral Disease MeSH:Malnutrition Virus Diseases
HPO:Malnutrition
Primary Outcomes
Description: Body Mass Index evolution from baseline
Measure: Body Mass Index Time: 1 Month
Description: Body Mass Index evolution from baseline
Measure: Body Mass Index Time: 3 Months
Secondary Outcomes
Description: Usual weight at baseline vs weight before confinement (gk)
Measure: Weight changes during confinement Time: 8 weeks
Description: number and type of nutritional supplements from baseline
Measure: prescription of nutritional supplements and observance Time: 3 months
HPO Nodes
Primary Outcomes
Description: Body Mass Index evolution from baseline
Measure: Body Mass Index Time: 1 MonthDescription: Body Mass Index evolution from baseline
Measure: Body Mass Index Time: 3 MonthsSecondary Outcomes
Description: Usual weight at baseline vs weight before confinement (gk)
Measure: Weight changes during confinement Time: 8 weeksDescription: number and type of nutritional supplements from baseline
Measure: prescription of nutritional supplements and observance Time: 3 months