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2025-05-29
2026-06-01
2026-09-01
20
NCT06852014
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
INTERVENTIONAL
Effects of Peptamen 1.6 in Malnourished Patients (or at Risk) With Pancreatic Neoplasia Undergoing Cephalic Pancreaticoduodenectomy (CPD): A Mechanistic Study
Malnutrition is a common challenge in patients with pancreatic cancer undergoing cephalic pancreaticoduodenectomy (CPD), impacting postoperative recovery and overall prognosis. Nutritional support plays a crucial role in optimising metabolic, inflammatory, and digestive outcomes. This randomised, double-blind, crossover clinical trial aims to evaluate the effects of Peptamen 1.6, a hydrolysed whey protein-based enteral formula, compared to Resource HP/HC, a high-protein and high-calorie polymeric formula, in malnourished or at-risk patients with pancreatic cancer undergoing PD. The study comprises both in vivo and in vitro analyses. The in vivo component will assess the impact of Peptamen 1.6 on digestive tolerance, amino acid absorption, nutritional status, metabolic profile, inflammatory markers, and gut microbiota composition. The in vitro component will utilise human intestinal organoid models to explore how enteral nutrition formulations influence intestinal permeability and metabolism, with a focus on microbiota interactions. Primary outcomes include improvements in metabolic status, assessed through serum biomarkers (albumin, immune markers, intestinal permeability, and myosin profile), inflammatory status via peripheral blood mononuclear cells (PBMCs), and microbiota shifts in faecal samples. Additionally, adherence to treatment, digestive tolerance, and changes in body composition will be monitored using bioelectrical impedance, dynamometry, and functional mobility tests. By elucidating the mechanisms through which different enteral nutrition strategies influence clinical, physiological, and molecular parameters, this study aims to enhance personalised nutritional interventions for patients with pancreatic cancer. The findings could contribute to optimising nutritional support strategies, ultimately improving patient outcomes following CPD.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2025-02-13 | N/A | 2025-08-26 |
2025-02-21 | N/A | 2025-09-02 |
2025-02-28 | N/A | 2025-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Crossover
Masking:
Double
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: EXPERIMENTAL GROUP A (Nutritional supplement order A --> B) | DIETARY_SUPPLEMENT: Dietary Supplement: Experimental Treatment with nutritional suplement A + nutritional suplement B
|
| EXPERIMENTAL: EXPERIMENTAL : EXPERIMENTAL GROUP B (Nutritional supplement order B --> A) | DIETARY_SUPPLEMENT: Dietary Supplement: Dietary Supplement: Experimental Treatment with nutritional suplement B + nutritional suplement A
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Adherence to nutritional treatment | Categorized based on the average daily consumption compared to the prescribed volume (200 ml per bottle): * Full content (200 ml/bottle) * 2/3 content (150 ml/bottle) * 1/2 content (100 ml/bottle) * 1/4 content (50 ml/bottle) Patients will self-report their average daily consumption (ml/day). | At weeks 6 and 13 |
| Natural food intake | Patients will report their food intake over the previous week, categorized into quartiles (%) relative to: * Pre-illness consumption * Perceived normal intake for patients without supplementation * ALL -100% * 3/4 - 75% * HALF - 50% * ¼ - 25% * NONE - 0% | At weeks 6 and 13 |
| Tolerance to nutritional treatment | Evaluated based on the frequency of gastrointestinal symptoms (e.g., nausea, vomiting, reflux, abdominal pain, flatulence, satiety, constipation, and stomach heaviness) within two hours of supplement consumption. Symptoms classified as: * Never * Rarely * Sometimes * Frequently * Always Bivariate analysis will classify tolerance as: * Good (no symptoms) * Poor (presence of any gastrointestinal symptoms) | At weeks 6 and 13 |
| Change in aminoacids: Ala, Glu, Asp, Pro, Phe, Leu/Ile, Val, Tyr, Met, Cit, Arg, Gly, and Orn | Aminoacids measured in µmol/L | At baseline and in weeks 6, 7, and 13 |
| Change in IL-6 and TNF-alpha RNA expression | IL-6 and TNF-alpha measured from Peripheral blood mononuclear cell (PBMC) | At baseline and in weeks 6, 7, and 13 |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Doses of pancreatic enzyme replacement therapy | Measured in International Unit per day (IU/day) | Only at baseline |
| Stool characteristics | The number and type of stools will be assessed using the Kings Stool Chart, a standardized tool that classifies stool consistency and form to evaluate digestive function alterations. * Number of bowel movements: A numerical field to record the daily count. * Type of bowel movements: A categorical field with options ranging from 1 to 7, based on the King's Stool Chart. * Variability in type: A binary field (0 = No, 1 = Yes) to indicate whether there is variation. | At baseline and in weeks 6, 7, and 13 |
| Symptoms of anxiety and depression | Measured using the Hospital Anxiety and Depression Scale (HADS), which consists of two subscales: HADS-Anxiety (HADSA) and HADS-Depression (HADSD) Interpretation of scores: * 0-7: Normal. * 8-10: Suggests the presence of mood disorders. * ≥11: Indicates a probable mood disorder. | At baseline and in weeks 6, 7, and 13 |
| Nutritional status | Evaluated using the Subjective Global Assessment (SGA) and Global Leadership Initiative on Malnutrition (GLIM) criteria, both validated tools for classifying malnutrition severity. Patients will be categorized as at risk of malnutrition or having moderate or severe malnutrition based on results. | At baseline and in weeks 6, 7, and 13 |
| Change in Phase angle (PhA) (Vectorial Bioimpedance Analysis (BIVA)) | Phase angle (PhA) measured in degrees (º) | At baseline and in weeks 6, 7, and 13 |
| Change in total body water (TBW) (Vectorial Bioimpedance Analysis (BIVA)) | Total body water (TBW) measured in liters (l) | At baseline and in weeks 6, 7, and 13 |
| Change in extracellular water (ECW) (Vectorial Bioimpedance Analysis (BIVA)) | Extracellular water (ECW) measured in liters (l) | At baseline and in weeks 6, 7, and 13 |
| Change in intracellular water (ICW) (Vectorial Bioimpedance Analysis (BIVA)) | Intracellular water (ICW) measured in liters (l) | At baseline and in weeks 6, 7, and 13 |
| Change in Fat-free mass (FFM) (Vectorial Bioimpedance Analysis (BIVA)) | Fat-free mass (FFM) measured in kilograms (kg) and percentage (%) | At baseline and in weeks 6, 7, and 13 |
| Change in Fat mass (FM) (Vectorial Bioimpedance Analysis (BIVA)) | Fat mass (FM) measured in kilograms (kg) and percentage (%) | At baseline and in weeks 6, 7, and 13 |
| Change in Body cell mass (BCM) (Vectorial Bioimpedance Analysis (BIVA)) | Body cell mass (BCM) measured in kilograms (kg) | At baseline and in weeks 6, 7, and 13 |
| Change in appendicular skeletal muscle mass (ASMM) (Vectorial Bioimpedance Analysis (BIVA)) | Appendicular skeletal muscle mass (ASMM) measured in kilograms (kg) | At baseline and in weeks 6, 7, and 13 |
| Change in skeletal muscle index (SMI) (Vectorial Bioimpedance Analysis (BIVA)) | Skeletal muscle index (SMI) measured in kilogram per square meter (kg/m²) | At baseline and in weeks 6, 7, and 13 |
| Change in hydration (Vectorial Bioimpedance Analysis (BIVA)) | Hydration measured in percentage (%) | At baseline and in weeks 6, 7, and 13 |
| Change in resistance (Vectorial Bioimpedance Analysis (BIVA)) | Resistance measured in ohms (Ω) | At baseline and in weeks 6, 7, and 13 |
| Change in reactance (Vectorial Bioimpedance Analysis (BIVA)) | Reactance measured in ohms (Ω) | At baseline and in weeks 6, 7, and 13 |
| Handgrip dynamometry | * Device: Jamar hydraulic dynamometer * Measurement: Mean and maximum grip strength (kg) from three measurements Used to assess sarcopenia | At baseline and in weeks 6, 7, and 13 |
| Timed Up and Go (TUG) Test | * Measures mobility and physical function * Procedure: Time (seconds) taken for the patient to: 1. Rise from a chair 2. Walk a short distance 3. Return to the chair | At baseline and in weeks 6, 7, and 13 |
| Change in total fat (Abdominal Ultrasound) | Total fat measured in centimeters (cm) | At baseline and in weeks 6, 7, and 13 |
| Change in superficial fat (Abdominal Ultrasound) | Superficial fat measured in centimeters (cm) | At baseline and in weeks 6, 7, and 13 |
| Change in preperitoneal fat (Abdominal Ultrasound) | Preperitoneal fat measured in centimeters (cm) | At baseline and in weeks 6, 7, and 13 |
| Change in muscle Ultrasound - Area | Area measured in square centimeters (cm²) | At baseline and in weeks 6, 7, and 13 |
| Change in muscle Ultrasound - Circumference | Circumference measured in centimeters (cm) | At baseline and in weeks 6, 7, and 13 |
| Change in muscle Ultrasound - X-axis and Y-axis | X-axis and Y-axis measured in centimeters (cm) | At baseline and in weeks 6, 7, and 13 |
| Change in muscle Ultrasound - Adipose tissue of the rectus femoris of the quadriceps | Adipose tissue of the rectus femoris of the quadriceps measured in centimeters (cm) | At baseline and in weeks 6, 7, and 13 |
| Change in Glucose | glucose measured in mg/dl | At baseline and in weeks 6, 7, and 13 |
| Change in Cholesterol | Cholesterol measured in mg/dl | At baseline and in weeks 6, 7, and 13 |
| Change in Triglycerides | Triglycerides measured in mg/dl | At baseline and in weeks 6, 7, and 13 |
| Change in Uric acid | Uric acid measured in mg/dl | At baseline and in weeks 6, 7, and 13 |
| Change in AST | AST measured in units per litre (U/L) | At baseline and in weeks 6, 7, and 13 |
| Change in ALT | ALT measured in units per litre (U/L) | At baseline and in weeks 6, 7, and 13 |
| Change in GGT | GGT measured in units per litre (U/L) | At baseline and in weeks 6, 7, and 13 |
| Change in ALP | ALP measured in units per litre (U/L) | At baseline and in weeks 6, 7, and 13 |
| Change in insulin | Insulin measured in units per mililitre (U/mL) | At baseline and in weeks 6, 7, and 13 |
| Change in albumin | Albumin measured in grams per liter (g/l) | At baseline and in weeks 6, 7, and 13 |
| Change in C-reactive protein (CRP) | C-reactive protein (CRP) measured in milligrams per liter (mg/L) | At baseline and in weeks 6, 7, and 13 |
| Change in Intestinal fatty acid-binding protein (I-FABP) | Intestinal fatty acid-binding protein (I-FABP) measured in picograms per milliliter (pg/mL) | At baseline and in weeks 6, 7, and 13 |
| Change in zonulin | Zonulin measured in micrograms per milliliter (μg/mL) | At baseline and in weeks 6, 7, and 13 |
| Change in musclin | Musclin measured in nanograms per milliliter (ng/mL) | At baseline and in weeks 6, 7, and 13 |
| Change in galectin-3 | Galectin-3 measured in nanograms per milliliter (ng/mL) | At baseline and in weeks 6, 7, and 13 |
| Change in myostatin | Myostatin measured in nanograms per milliliter (ng/mL) | At baseline and in weeks 6, 7, and 13 |
| Change in Total antioxidant capacity (TAC) | Total antioxidant capacity (TAC) measured in nanomoles per microliter (nmol/μL) | At baseline and in weeks 6, 7, and 13 |
| Change in Glutathione peroxidase (GSH-Px) | Glutathione peroxidase (GSH-Px) measured in milliunits per milliliter (mU/mL) | At baseline and in weeks 6, 7, and 13 |
| Change in Superoxide dismutase (SOD) | Superoxide dismutase (SOD) measured in inhibition rate % | At baseline and in weeks 6, 7, and 13 |
| Change in GLP-1 | GLP-1 measured in picograms per milliliter (pg/mL) | At baseline and in weeks 6, 7, and 13 |
| Change in GIP | GIP measured in picograms per milliliter (pg/mL) | At baseline and in weeks 6, 7, and 13 |
| Change in PYY | PYY measured in picograms per milliliter (pg/mL) | At baseline and in weeks 6, 7, and 13 |
| Change in IFN-gamma | IFN-gamma measured in picograms per milliliter (pg/mL) | At baseline and in weeks 6, 7, and 13 |
| Change in IL-2 | IL-2 measured in picograms per milliliter (pg/mL) | At baseline and in weeks 6, 7, and 13 |
| Change in IL-4 | IL-4 measured in picograms per milliliter (pg/mL) | At baseline and in weeks 6, 7, and 13 |
| Change in IL-6 | IL-6 measured in picograms per milliliter (pg/mL) | At baseline and in weeks 6, 7, and 13 |
| Change in IL-10 | IL-10 measured in picograms per milliliter (pg/mL) | At baseline and in weeks 6, 7, and 13 |
| Change in IL-12p70 | IL-12p70 measured in picograms per milliliter (pg/mL) | At baseline and in weeks 6, 7, and 13 |
| Change in IL-17A | IL-17A measured in picograms per milliliter (pg/mL) | At baseline and in weeks 6, 7, and 13 |
| Change in TNF-alpha | TNF-alpha measured in picograms per milliliter (pg/mL) | At baseline and in weeks 6, 7, and 13 |
| Change in stool calprotectin | Calprotectin measured in micrograms per gram (µg/g) | At baseline and in weeks 6, 7, and 13 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Gabriel Olveira Fuster, MD, PhD Phone Number: 951290343 Email: gabrielm.olveira.sspa@juntadeandalucia.es |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
