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Malnutrition clinical trials

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NCT ID: NCT05417672 Recruiting - Lung Cancer Clinical Trials

Assessment of Relationship Between Preoperative Nutritional Status and Perioperative/Postoperative Conditions in Patients With Lung Cancer Scheduled for Lobectomy

Start date: September 29, 2021
Phase:
Study type: Observational

Malnutrition is common in patients with lung cancer. In patients with malnutrition risk, the risk of complications is high both in the perioperative, early and late postoperative periods. Malnutrition is an independent risk factor for length of hospital stay and cost in these patients. Patients with lung cancer may have many morbidities in postoperative period, especially problems with wound healing. Therefore, assessment of the nutritional status of patients with lung cancer should begin at the diagnosis stage.

NCT ID: NCT05416697 Recruiting - Malnutrition Clinical Trials

Effectiveness of Cannabinoids on Appetite in Scleroderma

Start date: November 9, 2022
Phase: Phase 3
Study type: Interventional

The cannabinoid has benefits in many aspects but the evidence of the effect of cannabinoids in humans with SSc is limited. We, therefore, would like to investigate the efficacy of cannabinoids on the appetite, sleep efficiency, quality of life, pain, and critical cytokine level in SSc compared with placebo in SSc patients and the adverse events associated with cannabinoids in those patients.

NCT ID: NCT05389098 Recruiting - Undernutrition Clinical Trials

Finger Food, Pleasure at Your Fingertips: Randomized Pilot Study, Open-label and Parallel Groups

PLAID
Start date: August 3, 2023
Phase: N/A
Study type: Interventional

Food is available in easy-to-grip bites that allow residents in care settings to use their fingers for food. This new way of eating can help limit weight loss, increase food intake, gain independence and improve the enjoyment of eating for residents.

NCT ID: NCT05361148 Recruiting - Diabetes Clinical Trials

Long-term Health After Severe Acute Malnutrition in Children and Adults: the Role of the Pancreas

SAMPA
Start date: October 12, 2021
Phase:
Study type: Observational

Whilst there is an increasing prevalence of overweight and obesity worldwide, malnutrition remains common. In addition, malnutrition, overweight, and infections often interact. The consequences of malnutrition after birth are little studied. Severe acute malnutrition in childhood remains common in Africa and Asia and many adult patients with tuberculosis or HIV, diseases which are common in Africa and Asia, may become malnourished. We are interested in diabetes, which in Africa and Asia affects people at younger age and lower weight than in Europe. There is evidence that severe postnatal malnutrition increases the risk of later diabetes but the evidence is piecemeal and there is little information as to the mechanisms involved. It is thus difficult to determine what treatments or preventative strategies are appropriate. We wish to focus on the pancreas which is a key organ in digestion and metabolic processes, especially in relation to diabetes. We will investigate pancreas size, microscopic structure, hormone and digestive enzyme production, and the body's response to these hormones among groups of people in Tanzania, Zambia, India and the Philippines. These groups have participated in the research team's previous studies of malnutrition and were malnourished before birth, as children, or as adults. They now live in places with a wide range of access to foods high in fat and sugar which could affect their risk of diabetes. We will compare their pancreas function to that of never-malnourished controls at each site. We will use advanced statistical methods to understand the links between early malnutrition and later diabetes, taking into account the factors often associated with diabetes such as age, current overweight and infection. Even if we find no important link between early malnutrition and later diabetes, the research will lead to improved understanding of the long-term consequences of malnutrition and the presentation and underlying metabolism of diabetes in Africa and Asia. Thus, the project will lead to improved health care for both malnourished and diabetic people.

NCT ID: NCT05343611 Recruiting - Dementia Clinical Trials

Chocolate and Physical Exercise to Reduce Malnutrition in Pre-dementia Aged People

Choko-AGE
Start date: May 1, 2022
Phase: N/A
Study type: Interventional

We hypothesize that the antioxidant and cytoprotective functions of vitamin E combined with the cortisol-lowering effect of chocolate polyphenols and physical activity may help prevent the age-dependent decline of mitochondrial function and nutrient metabolism in skeletal muscle, key underpinning events in protein-energy malnutrition (PEM) and muscle wasting in the elderly. To test this hypothesis, a vitamin E functionalized dark chocolate rich in polyphenols will be developed with the collaboration of Nestlè Company, and its effects will be investigated combined with physical activity in a 6-month randomized case-control trial on pre-dementia elderly patients, a well-defined population of subjects at risk of undernutrition and frailty. Subjects stabilized on a protein-rich diet (0.9-1.0 g protein/Kg ideal body weight/day) and physical exercise program (High Intensity Interval Training specifically developed for these subjects), will be randomized in 3 groups (n = 34 each): controls (Group A) will maintain the baseline diet and cases will receive either 30 g/day of dark chocolate containing 500 mg total polyphenols (corresponding to 60 mg epicatechin) and 100 mg vitamin E (as RRR-alpha-tocopherol) (Group B) or the high polyphenol chocolate without additional vitamin E (Group C). Diet will be isocaloric and with the same intake of polyphenols and vitamin E in the 3 groups. Muscle mass will be the primary endpoint and other clinical endpoints will include neurocognitive status and previously identified biomolecular indices of frailty in pre-dementia patients. Muscle biopsies will be collected to assess myocyte contraction and mitochondrial metabolism. Laboratory endpoints will include the nutritional compliance to the proposed intervention (blood polyphenols and vitamin E status and metabolism), 24-h salivary cortisol, steroid hormones and IGF-1, and molecular indices of inflammation, oxidant stress, cell death and autophagy. These parameters will be investigated in muscle and blood cells by state-of-the-art omics techniques. Molecular and nutritional findings will also be confirmed in vitro using skeletal myotubes, blood leukocytes and neural cell lines. Clinical and laboratory results will be processed by a dedicated bioinformatics platform (developed with the external collaboration of the omics company Molecular Horizon Srl) to interpret the molecular response to the nutritional intervention and to personalize its application.

NCT ID: NCT05311436 Recruiting - Health Behavior Clinical Trials

Nutri-CAP: Nutrition for Children, Adolescent Girls, and Pregnant Women in Slums of Dhaka City

Start date: July 1, 2022
Phase: N/A
Study type: Interventional

The objective of the research project is to establish an evidence-based sustainable nutrition service delivery platform for optimizing pregnancy weight gain, increasing dietary diversity of adolescent girls, and ensuring proper physical growth of under 2 children. Hypothesis 1. Pregnant Women: Intensive nutrition and WASH counseling, iron-folate, calcium supplementation during pregnancy, can improve gestational weight gain and improve hemoglobin status in pregnant women in a slum of Dhaka city 2. Adolescent girl: Iron and zinc supplementation and nutrition counseling on dietary diversity could improve nutritional status and dietary diversity score in adolescent girls of slums in Dhaka 3. Children <2 years: Counselling on IYCF, growth monitoring, and promotion, ensuring six-monthly vitamin A supplementation, counseling on WASH, treatment of acute malnutrition, and daily 1 egg supplementation for 3 months for severely stunted children can improve the nutritional status of children 4. Counselling to improve Water, Sanitation and Hygiene (WASH) practice: WASH intervention can improve EED biomarkers

NCT ID: NCT05309759 Recruiting - Undernutrition Clinical Trials

Impact of Undernutrition Definitions on Its Prevalence in Hospitalized Patients

PROTEIN
Start date: February 10, 2022
Phase:
Study type: Observational

In France, the prevalence of undernutrition among hospitalized patients varies from 30 to 50%. Undernutrition is strongly associated with a decrease in the patient's functional capacities and an increase in morbidity and mortality and in healthcare costs. In 2019, the Global Leadership Initiative on Malnutrition (GLIM) and the Haute Autorité de Santé (HAS) are each publishing updated diagnostic criteria for undernutrition in adults aged <70 years. Aetiological and phenotypic criteria are retained: reduced food intake, inflammatory state, weight loss, BMI and reduced muscle mass. Reduced muscle mass has become a major diagnostic criterion and various measurement tools are suggested, such as bioelectrical impedancemetry, grip strength measurement or magnetic resonance imaging. Collaboration between dieticians, physiotherapists, nurses, care assistants and doctors makes it possible to respond to the need to screen for undernutrition according to these new definitions, which involve a multidisciplinary assessment. These two definitions are very similar but differ on the time period of weight loss, on the BMI cut-off values and on the thresholds for muscle mass loss. The GLIM definition may be less selective than the HAS definition. The investigators hypothesise that the prevalence of undernutrition in a population of adult patients hospitalised in diabetology-obesity, pneumology, oncology and gastro-nutrition, aged < 70 years, is different according to the diagnostic criteria recommended by the HAS or by the GLIM, and may be associated with a different patient morbi-mortality. In addition, the choice of the method of assessment of muscle function could impact this prevalence. The main objective of this study is to compare the prevalence of global undernutrition based on the diagnostic criteria recommended by the HAS with that based on the diagnostic criteria recommended by the GLIM, in patients hospitalised in diabetes-obesity, pneumology, oncology and gastro-nutrition units. The secondary objectives will be, in patients hospitalized in diabetes-obesity, pneumology, oncology and gastro-nutrition units: - To compare the prevalence of severe undernutrition between the HAS and GLIM groups; - To compare the morbi-mortality of undernutrition between the HAS and GLIM groups on : - Length of hospital stay ; - Mortality rate; - Autonomy at discharge. - To evaluate the impact of the choice of the muscle function assessment tool on the prevalence of undernutrition in the HAS and GLIM groups. This is a prospective, monocenter, observationnal and cohort study. Patients hospitalised in acute and rehabilitation care for diabetes-obesity, pneumology, oncology and gastro-nutrition purpose. Univariate comparisons will use the usual statistical tests after verification of the distribution of the variables (Chi2 or Fisher's test, t-test, anova or their non-parametric equivalents Wilcoxon and Kruskal-Wallis tests). The variables will be compared between the two groups by the appropriate tests according to the type of variables (quantitative or qualitative) and their distribution. The results of this study will make it possible to verify whether the GLIM definition increases the prevalence of undernutrition compared to that of the HAS. The use of one or other of the definitions could thus have an impact on the medical and paramedical management of undernutrition. On the other hand, muscle function benefits from different assessment tools, which could lead to a different estimate of the reduction in muscle mass and therefore a different prevalence of undernutrition. The results of our study will help to evaluate this and guide professionals in the choice of tools for assessing muscle function.

NCT ID: NCT05308862 Recruiting - Malnutrition Clinical Trials

PROSENIOR. Prevention of Pressure Ulcers, Malnutrition, Poor Oral Health and Falls Among Older Persons Receiving Municipal Health Care and Are Registered in the Quality Registry Senior Alert

Start date: January 19, 2022
Phase: N/A
Study type: Interventional

Inclusion criteria for study I and II is nurse aides, registered nurses and managers working in nursing homes who register in Senior Alert. To develop an intervention aiming to reduce the risk of pressure ulcers, malnutrition, poor oral health and falls among older persons in nursing homes, workshops will be conducted in collaboration with nurse aides, registered nurses and managers (study I). Cluster randomization is going to take place via a computerized program prior to the workshops meaning that only those nurse aides, registered nurses and managers working in nursing homes allocated to the intervention group are going to develop an intervention together with the research group and then test it (study II). The remaining nurse aides, registered nurses and managers working in nursing homes in the control group continue with regular care.

NCT ID: NCT05306925 Recruiting - Surgery Clinical Trials

An Exploratory Study of Arginine Supplementation and the Postoperative Immune REsponse

ASPIRE
Start date: April 14, 2022
Phase: N/A
Study type: Interventional

ASPIRE is a nutrition study focusing on the effect of arginine supplementation on immune function in postoperative infants. The investigators will explore the effect of current intravenous feeding (parenteral nutrition (PN)) formulations and oral arginine supplementation on blood arginine levels and the genes that are involved in body nutrition and fighting infection in babies who have had major bowel surgery or been diagnosed with necrotising enterocolitis. The investigators will undertake an exploratory physiological study across two sites under which are part of a single neonatal partnership. 48 infants will be recruited; 24 preterm infants and 24 term/near term infants. 16 of these infants (8 preterm and 8 term/near term) will be supplemented with arginine in both oral and parenteral form, 16 infants will receive arginine supplementation in oral form alone and 16 infants will receive standard nutrition with no arginine supplement. The investigators will record nutritional intake and routine biochemical testing data (which includes amino acid levels) collected over the first 30 days post surgery or post NEC diagnosis. The investigators will take blood for analysis at prespecified intervals for RNA sequencing, ammonia and metabolomics. RNA sequencing findings will allow the investigators to describe the effect of arginine on gene activity in postoperative infants The investigators hypothesise that arginine supplementation will result in changes in gene expression that are consistent with changes in T-cell function and associated inflammatory pathways.

NCT ID: NCT05299112 Recruiting - Clinical trials for Nutritional Deficiency

An Exploratory Study of Increased Preterm Arginine INTake (PAINT18)

PAINT18
Start date: December 7, 2021
Phase: N/A
Study type: Interventional

PAINT18 is a nutrition study focusing on the effect of arginine supplementation on immune function in preterm infants. The investigators will explore the effect of current intravenous feeding (parenteral nutrition (PN) formulations on blood arginine levels and the genes that are involved in body nutrition and fighting infection in premature babies. The investigators will also investigate the effect of supplementing arginine on these genes. The investigators will undertake a single centre exploratory physiological study in 24 very premature infants receiving PN. 16 of these infants will be supplemented with arginine. The investigators will record nutritional intake and routine biochemical testing data (which includes amino acid levels) collected over the first 30 days of life. The investigators will take blood for analysis at prespecified intervals for RNA sequencing, ammonia and IGF-1 levels. RNA sequencing findings will allow the investigators to describe the effect of arginine on gene activity in preterm infants The investigators hypothesise that arginine supplementation will result in changes in gene expression that are consistent with changes in T-cell function and associated inflammatory pathways.