Malnutrition (Calorie)

11

Review clinical trials related to Malnutrition (Calorie). Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Nutritional Status in Adults With Diabetic Foot Ulcers

This feasibility and pilot study has two aims. The primary aim is to assess the feasibility of collecting clinical, nutritional, and functional data among adults with diabetic foot ulcers (DFUs) who are treated at an outpatient wound clinic. Specifically, the study will evaluate recruitment and inclusion rates, the relevance and clinical utility of selected variables, and assess the completeness and reliability of data collection. The secondary aim is to provide a preliminary characterisation of nutritional status, dietary intake, body composition, muscle strength, mobility, and wound-related quality of life, to inform the design and methodology of a future full-scale national study. DFUs are associated with delayed healing, recurrent infections, reduced quality of life, and increased risk of hospitalization and amputation. These conditions are frequently accompanied by systemic inflammation, impaired circulation, and metabolic disturbances, which may increase nutritional requirements and negatively affect wound healing. Despite nutrition being recognized as a modifiable factor of ulcer healing, the nutritional status of individuals with DFUs remains insufficiently characterised, and evidence regarding clinically relevant nutritional deficiencies in this population is limited. Participants will undergo assessment of height, weight, body composition, handgrip strength, and a 24-hour dietary recall interview during an outpatient clinic visit. Nutritional screening questionnaires and patient-reported measures of appetite, nutritional impact symptoms, mobility, and quality of life will be collected through telephone interviews within one week of the clinical visit. Eligible participants are adults (\>18 years) who are referred to the outpatient wound clinic with a hard-to-heal foot ulcer. Participants must be able to communicate in Danish or English.

Participants needed: 30
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Hvidovre University HospitalUpdated: Jun 2, 2026
Eligibility criteria

Age ≥ 18 years [+4]

Above ankle amputation of the contralateral leg [+4]

Status: Not yet recruiting

Optimizing Patient Treatment With EPA-enriched Nutrition, a Randomised Control Trial

Malnutrition is a common and serious issue for people living with cancer. Many cancer patients experience weight loss, muscle weakness, and poor quality of life due to malnutrition. This can also reduce the success of cancer treatments, increase hospital visits, and add emotional distress for both patients and their loved ones. Treating malnutrition through good nutritional care is increasingly recognised as an important part of cancer treatment. Leading experts recommend that all cancer patients be checked for signs of malnutrition and given personalised nutrition plans when necessary. While dietary counselling and oral nutritional supplements (ONS) are often used to help patients, there is still a need for better evidence to show how well these interventions work. A key factor contributing to malnutrition in cancer patients is inflammation. Omega-3 fatty acids, (like those found in oily fish) are known for their anti-inflammatory properties. Some studies suggest that omega-3s may help cancer patients by reducing inflammation, keeping muscles strong, improving appetite, and enhancing overall well-being. The OPT-EPA study will investigate whether a nutritional drink, called Fortimel Forticare Sensations (FFS), can improve nutritional status in patients with lung or colorectal cancer who are at risk of malnutrition. This drink is enriched with omega-3 fatty acids (Eicosapentanoic acid (EPA) and Docosahexaenoic acid (DHA)) and provides a high amount of protein and calories in a small volume, making it easier to consume, especially for patients with taste changes. In this study, participants will be divided into two groups. The experimental group will receive dietary counselling and standard care along with FFS, the omega-3-enriched nutritional drink, while the other (control) group will receive dietary counselling and standard care, with supplements provided only if clinically necessary. Researchers will evaluate the impact on patients' nutritional status, body weight, muscle, inflammation levels, and quality of life. Through the OPT-EPA study, researchers hope to gain clearer insights into whether omega-3-containing supplements can provide meaningful benefits for cancer patients. Ultimately, this could help improve the quality of care and outcomes for people facing cancer-related malnutrition.

Participants needed: 118
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University of EdinburghUpdated: May 4, 2026
Eligibility criteria

Participants with stage III-IV lung and/or colorectal cancer undergoing systemic... [+5]

Participants with a recent history of tumour resection (within 12 months) [+6]

Status: Not yet recruiting

Stunting and Targeting Reduction of Impaired Growth in Kids Effectively

The objective of this prospective, real-world evidence/pragmatic study with a quality improvement program approach is to evaluate the feasibility and effectiveness of a community-engaged nutrition-focused program utilizing nutrition screening, education, supplementation and continuous follow up for children and their families.

Participants needed: 150
Trial details
Age: 1-5Biological sex: AllType: ObservationalSponsor: Abbott NutritionUpdated: Apr 13, 2026Locations: 1
Eligibility criteria

Children aged 1-5 years experiencing stunting or its risk (defined as HAZ ≤ -1 S... [+17]

Status: Recruiting

Goat Milk-Derived Formula vs. Undiluted Goat Milk in Infants Unable to Exclusively Breastfeed: Growth and Biomarker Analysis

The goal of this clinical trial is to learn if Goat Milk-Derived Formula Alternatives (GMDFA) are safe and effective for infants who are unable to be exclusively breastfed. It will also study growth patterns, biological markers, and gut microbiome differences among infants receiving GMDFA, undiluted goat milk, or breast milk. The main questions it aims to answer are: 1. Do infants receiving GMDFA show similar growth patterns to those who are breastfed? 2. Are biological markers of gut health and nutrition (such as calprotectin, lipocalin-2, CRP, and claudin) comparable between the groups? 3. How do feeding types (GMDFA, goat milk, or breast milk) influence the infant gut microbiome composition, metabolic pathways, and lipid profiles? 4. Is GMDFA a safe and nutritionally adequate feeding option for infants unable to be exclusively breastfed? We will compare GMDFA, undiluted goat milk, and breast milk (reference group) to evaluate infant growth, gut health, and metabolic outcomes. Participants will: Be randomly assigned to one of three feeding groups: GMDFA, undiluted goat milk, or breastfed Attend regular follow-up visits for growth measurements and sample collection (blood, stool, and breast milk where applicable) Have feeding practices monitored and recorded through caregiver interviews and feeding logs Additional Analyses: Microbiome analysis: to identify gut bacterial diversity and composition across feeding groups Metagenomic analysis: to explore functional genes and metabolic pathways related to nutrition and gut health Lipidomic analysis: to assess differences in lipid and fatty acid profiles in breast milk, goat milk, and infant samples

Participants needed: 15
Trial details
Age: 8-10Biological sex: AllType: InterventionalSponsor: Aga Khan UniversityUpdated: Mar 30, 2026Locations: 1
Eligibility criteria

• Infants aged = 08 -10 weeks with WAZ better than -1.8. (NIPS & ICF, 2019) Age... [+5]

• Infant birth weight < WAZ -1.8 i.e. weight-for-age based on established growth... [+6]

Status: Recruiting

REMS25: Study on the Use of REMS Technology in Diseases Commonly Associated With Reduced Bone Mineral Density (BMD)

This study evaluates bone mineral density (BMD) in pediatric patients aged 5-18 years with conditions negatively affecting bone health, using REMS (Radiofrequency Echographic Multi Spectrometry), a non-invasive and radiation-free ultrasound technology. Bone health is crucial during childhood, when peak bone mass develops, and reduced BMD is associated with increased fracture risk. DXA is the current reference method but has limitations in children, including radiation exposure and growth-related measurement issues. REMS has been validated in adults and shows promise in pediatrics, despite the lack of reference values. The study is a single-center, national, non-profit interventional study lasting about 12 months. Participants will undergo REMS BMD measurement, clinical history collection, and assessment of anthropometric and pubertal parameters, with prior DXA data collected when available. The primary aim is to describe BMD values measured by REMS in pediatric osteoporosis, with secondary aims including subgroup analyses and comparison with DXA. A sample of 100 patients is planned. Statistical analyses will assess BMD distributions, correlations with clinical variables, and agreement between REMS and DXA using correlation coefficients and Bland-Altman analysis.

Participants needed: 100
Trial details
Age: 5-18Biological sex: AllType: InterventionalSponsor: Meyer Children's Hospital IRCCSUpdated: Feb 17, 2026Locations: 1
Eligibility criteria

Written informed consent from adult patients or parents/legal guardians [+3]

Status: Recruiting

Malnutrition Screening Study

This is a non-interventional, cross-sectional, non-randomized, observational study to screen for the risk of malnutrition and sarcopenia in outpatients aged 18 and over who attend hospital clinics for any reason in Turkey.

Participants needed: 7,500
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Abbott NutritionUpdated: Jan 29, 2026Locations: 1
Eligibility criteria

Participant has voluntarily signed and dated an informed consent form (ICF), app... [+1]

NA

Status: Recruiting

Early Life Malnutrition, Environmental Enteric Dysfunction and Microbiome Trajectories

Malnutrition in women of reproductive age remains a public health concern in Sub-Saharan Africa (SSA). Malnutrition during pregnancy affects foetal growth with a tendency of the exposed infants to also develop it. The interaction of the mother with the infant shapes the seeding and the trajectory of the infant intestinal microbiota which is crucial for development of a healthy immune system Malnutrition has been associated with intestinal inflammation, intestinal leakage and reduced calorie absorption. Early life malnutrition and environmental enteric dysfunction (EED) immunopathology remains poorly described in the context of mother-infant dyads. This is essential as malnutrition, poor water, sanitation and hygiene (WASH), including the presence of infectious diseases limit the developmental potential of the exposed infants in SSA, including Zimbabwe. In addition, maternal stress and poor mental health may also affect standard hygiene practices, including how a mother cares for her baby, potentially aggravating EED and the risk of the infant being malnourished. Primary outcomes 1. Infant malnutrition and recovery. 2. Gut dysfunction (gut inflammation, leaky gut, malabsorption, dysbiosis) 3. Diarrhea episodes, defined as any episode of acute diarrhoea (≥3 passages of loose stool within 24 hours as reported by the mother) occurring before the next study visit. Definition of malnutrition outcomes to be assessed in babies born to malnourished women, is a mid- upper arm circumference (MUAC) \<23cm; * MUAC for age: Malnourished defined as those below -2 standard (SD) of the World Health Organisation (WHO) reference * Weight-for-age: Underweight defined as those below -2SD WHO reference * Weight-for-height: Wasted defined as those below -2SD WHO reference * Height-for-age: Stunted defined as those below -2SD WHO reference * Z-scores (as they are i.e. a continuous variable, taking age of infants into account) * A composite variable, any of malnourished, underweight, wasted or stunted.

Participants needed: 368
Trial details
Age: 18+Biological sex: FemaleType: ObservationalSponsor: University of ZimbabweUpdated: Sep 26, 2025Locations: 1
Eligibility criteria

MUAC ≤23 cm in pregnancy [+11]

Acute or chronic conditions in mothers interfering with the study according to t... [+1]

Status: Not yet recruiting

Nutritional Support With TGF-β2 Food for Special Medical Purposes (TGF-β2 FSMP) in Adult Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT) for the Prevention of Malnutrition: a Prospective, Randomized, Multicenter Study

prospective, randomized, multicenter study to confirm the potential benefits of TGF-β2 enriched FSMP. The primary objective is to evaluate the superiority of supplementing with TGF-β2 FSMP (experimental arm) compared to best supportive treatment (BST) in preventing malnutrition in patients submitted to allo-SCT. The secondary endpoints include the assessment of reduction of incidence of severe acute GVHD at day +100.

Participants needed: 214
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUpdated: Jun 8, 2025
Eligibility criteria

Intact intestinal tract [+3]

Active hematological disease at the beginning of conditioning [+5]

Status: Not yet recruiting

Brief Title: The Role of Nutrition in the Rehabilitation of Patients With Eating Disorders After a Vascular Stroke.

Brief Summary: The main objective of this thesis is to investigate the role of nutrition - specifically the administration of protein supplements (single dose and double dose) - in the rehabilitation of stroke patients with low albumin levels in relation to sarcopenia, osteopenia and functional recovery indices. The study will follow a randomized controlled trial design, incorporating clinical observation, analysis of biochemical markers, and assessment of physical and functional parameters. Participants will be randomly assigned to one of the three groups: (1) Group 1, receiving no protein supplementation (control group), (2) Group 2, receiving a single dose of protein supplement and (3) Group 3, receiving a double dose of protein supplement. The intervention will last for at least six weeks or until the biochemical markers of albumin normalize and the patient resumes regular oral intake. Biochemical assessment with be conducted through regular nutritional evaluations including measurement of serum albumin, prealbumin, C - reactive protein, creatinine, blood glucose and glycosylated hemoglobin (HbA1c), urea, electrolytes, urine albumin and additional inflammatory markers. Bone density will be assessed using DEXA, MBSR and hip measurements to determine the potential improvements resulting from the intervention. Muscle mass will be evaluated using whole - body DEXA analysis, while muscle strength and mobility will be assessed through grip strength tests and fine gait assessments. Functional recovery will be evaluated usings standardized tools for activities of daily living (Barthel Index), mental state (Geriatric Depression Scale) and quality of life (SF - 36), as well as mobility and walking tests such as the Timed Up and Go Test and 6 - Minute Walk Test. The collected data will be analyzed using appropriate statistical tools, including comparison models (ANOVA, Mann - Whitney U test) and correlation models (Pearson - Spearman). This research is expected to enhance theoretical knowledge regarding the relationship between nutrition, biochemical markers and rehabilitation outcomes in stroke patients with hypoalbuminemia. More specifically, it aims to explore the underlying mechanisms through which nutrition affects recovery - a field that remains unexplored. Additionally, the anticipated finding may contribute to the development of clinical guidelines and therapeutic approaches for the nutritional management of patients with low albumin levels, promoting personalized nutritional strategies that support effective post - stroke rehabilitation.

Participants needed: 100
Trial details
Age: 18-85Biological sex: AllType: InterventionalSponsor: University of IoanninaUpdated: May 8, 2025Locations: 1
Eligibility criteria

Age range: Adults aged 18 to 85 years [+4]

Severe infections or serious cardiopulmonary conditions: Patients with severe in... [+3]

Status: Not yet recruiting

Relative Energy Deficiency in Rowers

This study aims to learn about relative energy deficiency in male and female rowers at the end of the direct sport preparation phase of the annual training cycle. The main questions: \- How will energy intake influence leptin, cortisol levels, mood, gut discomfort, and permeability? The observational study involves male and female rowers from the Polish rowing team. Participants will perform 2000 meter ergometer test and 6000 ergometer test in annual training cycle. Researchers will compare outcomes from both tests.

Participants needed: 30
Trial details
Age: 18-23Biological sex: AllType: ObservationalSponsor: Poznan University of Physical EducationUpdated: Jun 13, 2024Locations: 1
Eligibility criteria

Membership in Polish Rowing Team, [+4]

Probiotics within the last three months, [+4]