Actively Recruiting

Age: 18Years - 85Years
All Genders
Healthy Volunteers
NCT07486947

Unveiling Malnutrition and Metabolic Changes in Lung Cancer Patients: Setting the Basis for Precision Nutrition Models.

Led by Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares · Updated on 2026-03-23

180

Participants Needed

3

Research Sites

102 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Malnutrition is a major cause of morbidity in a large portion of the population, particularly among people with specific medical conditions-such as lung cancer patients-and vulnerable population groups, such as pregnant women and the elderly. Lung cancer represents one of the most significant health problems in today's society, with an incidence of 1.8 million cases per year (13% of all cancer cases) and an estimated mortality of 1.6 million deaths annually, making it the leading cause of cancer-related death worldwide. The aim of this study is to collect data from different lung cancer patients in order to establish a precision nutrition recommendation model. The model will be capable of comprehensively characterizing the nutritional and metabolic status of individuals with nutritional impairment and, therefore, provide personalized dietary solutions based on the unique characteristics of each individual. To date, the number of personalized nutritional approaches to address malnutrition is relatively small; they have only been applied in very specific cases and generally have not addressed nutritional deficiencies as a whole but rather individual deficiencies. Additionally, these initiatives focused more on stratified nutrition (for groups of individuals) rather than precision nutrition (for individual persons), and in almost no case were factors such as genetics and the microbiome-key components of personalized nutrition-taken into account. This highlights the need to generate precision nutrition models that are capable of addressing the complexity of each individual and providing unique solutions for each nutritional and metabolic state. Despite the interest in these initiatives, no precise dietary personalization that considers the singularities of patients has been carried out to date. The proposed intervention is a prospective study whose main objective is to collect data for the proper and precise characterization of malnutrition status in lung cancer patients and to evaluate the role of major factors related to metabolic health (composition and functionality of genotype and gut microbiota, among others) and the pathogenesis and progression of cancer (tumor characterization, composition and functionality of the lung microbiota, etc.) on the nutritional status, quality of life, and prognosis of these patients. This nutritional study is therefore an exploratory initiative that takes into account several factors contributing to the nutritional and health status of malnourished individuals. The study will be conducted within the framework of the MENTORINNG project (Project ID: 101162297; Title: Addressing malnutrition and metabolic health in non-communicable diseases through precision Nutrition: impact on quality of life and prognosis of lung cancer patients). Under this umbrella, a multidisciplinary consortium has been created and funded under the "HORIZON-EIC-2023-PATHFINDERCHALLENGES-01; Programme: HORIZON; DG/Agency: EISMEA" call, with a budget of €4,031,666.25 for the development of scientific activities. Several international institutions are part of this consortium.

CONDITIONS

Official Title

Unveiling Malnutrition and Metabolic Changes in Lung Cancer Patients: Setting the Basis for Precision Nutrition Models.

Who Can Participate

Age: 18Years - 85Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients of both sexes
  • Aged between 18 and 85 years
  • Diagnosed with lung cancer (non-small cell or small cell)
  • Receiving chemotherapy, immunotherapy, biological therapy, conservative therapy, or no active treatment as per guidelines
  • Volunteers of both sexes
  • Volunteers aged between 18 and 85 years
  • Volunteers free of any oncological disease
Not Eligible

You will not qualify if you...

  • Patients with uncontrolled chronic diseases
  • Patients with acute gastrointestinal diseases
  • Volunteers with uncontrolled chronic diseases
  • Volunteers with acute gastrointestinal diseases
  • Volunteers who have had any type of cancer in their lives
  • Volunteers with diagnosed lung conditions such as chronic lung disease, asthma, pulmonary fibrosis, bronchiectasis, interstitial lung disease, recent pneumonia (within 3-6 months), moderate/severe sleep apnea, or tuberculosis with lasting effects
  • Volunteers with autoimmune diseases like rheumatoid arthritis, lupus, or multiple sclerosis
  • Volunteers with active or chronic infections including HIV, hepatitis B or C, recurrent chronic infections, or tuberculosis

AI-Screening

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Trial Site Locations

Total: 3 locations

1

University Hospital of Parma

Parma, Parma, Italy, 43126

Actively Recruiting

2

IMDEA Nutrition

Madrid, Madrid, Spain, 28034

Actively Recruiting

3

Infanta Sofía University Hospital

San Sebastián de los Reyes, Madrid, Spain, 28702

Actively Recruiting

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Research Team

J

Juan Moreno Rubio

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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