Clinical trial NCT06971666: Dietary Inflammatory Potential in Young Pleople With Obesity
Official title: Relationship Between Dietary Inflammatory Potential, Markers of Inflammation, Microbiota and Risk of Anxiety and Depression in Young People With Obesity
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Obesity
Dietary Inflammatory Index (DII)
Keywords: obesity
dietary inflammatory potential
dietary inflammatory index
inflammatory markers
gut microbiota
anxiety
depression
Lead sponsor: Instituto Tecnológico y de Estudios Superiores de Occidente
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals aged 18 to 24 years, diagnosed with obesity based on Body Mass Index (BMI), recruited from the Centro Universitario de Tonalá at the University of Guadalajara and ITESO between August 2024 and June 2025, residing in the Guadalajara Metropolitan Area.

Brief summary: The increase in adipose tissue in the young population is one of the most important and worrying public health problems because it persists in adulthood, constituting a risk factor for chronic degenerative diseases with social, economic, and environmental effects. The etiology of obesity is multifactorial and is associated with a low-intensity chronic inflammation process. Therefore, side effects of the digestive, nervous, endocrine, and immunological levels are closely related. Thus, understanding the impact of dietary components on the immune response and the pathophysiological complications of obesity will strengthen information on nutritional patterns with lower inflammatory implications.

Detailed description: 1. Background

   Obesity has become one of the most critical challenges in public health. It has become a global epidemic due to the exponential growth of obesity over the last 30 years, affecting developed and developing countries with a notable impact on the latter. In Mexico, the combined prevalence of overweight and obesity in adults is 75.2%, of which 36.9% correspond precisely to the prevalence of obesity.

   This pathology has a multifactorial etiology, links lifestyle, environment, and genetics, and is modulated by multiple interactions between psychological, cultural, and physiological factors. The World Health Organization defines obesity as the abnormal or excessive accumulation of adipose tissue, which can harm health. This accumulation of triglycerides in the adipocyte alters the secretion of specific molecules of the immune system, which causes a cascade of inflammation mediated by the secretion of inflammatory molecules.

   Likewise, it is observed that obese subjects present intestinal dysbiosis that leads to intestinal permeability that allows the passage of lipopolysaccharides from Gram-negative bacteria into the bloodstream. There, they are recognized as toxic agents by the immune system, and the secretion of inflammatory cytokines occurs. The immune response derived from increased adipose tissue and intestinal dysbiosis compromises different brain regions involved in regulating behavior, eating patterns, perception of satiety, and being involved in cognition and mood related to physical inactivity and more significant weight gain. The continuous circulation of inflammatory cytokines and their accumulation in organs, including the central nervous system, is a risk factor for altering neurotransmitters and signal transduction that could result in depression.

   In addition to the above, a close relationship has been reported between diet and the regulation of the inflammatory response, so changes in the dietary patterns of the Mexican population could be directly related not only to the excessive accumulation of adipose tissue but also to the persistent inflammatory response in this pathology. The Dietary Inflammatory Potential (DIP) tool has been used to evaluate the inflammation caused by an individual's diet based on their dietary inflammatory index (DII). The DII allows us to associate foods and their nutrients with markers that show pro-inflammatory or anti-inflammatory processes.

   Studies have analyzed the association of DIP with different diseases, such as vascular diseases, cancer, metabolic syndrome, and dysbiosis in patients with constipation. However, in the literature, three publications are identified that analyze DIP in people with obesity, where they consider that subjects with this disease already start from an inflammatory process. These studies evaluate this relationship between 20 and 60 years, which represents an extensive range of the population and implies a series of possible analysis biases inherent to the different age groups included in the sample and their metabolic and immunological particularities. It also stands out that none of these studies have been carried out in Mexico.
2. General objective

   To evaluate the relationship between Dietary Inflammatory Potential, markers of inflammation, microbiota, and risk of anxiety and depression in young people with obesity.
3. Hypothesis

   There is a relationship between Dietary Inflammatory Potential, inflammation markers, microbiota, risk of anxiety, and depression in young people with obesity.
4. Methodology

An original observational, cross-sectional, analytical, and correlational study in young people with obesity diagnosed with Body Mass Index. As part of the techniques and procedures, height and weight will be measured using the ISAK methodology to obtain the body mass index (BMI) and body mass with Dual X-ray Densitometry. Meanwhile, changes in intestinal microbiota and immunological parameters will be determined using the sequencing technique and ProQuantum High-Sensitivity Immunoassays, respectively. Questionnaires for evaluation of alimentary frequency, diet diversity, physical activity, and symptoms of anxiety and depression will be done.

Eligibility criteria: Inclusion Criteria:

* Both sexes with no gender exclusion
* Age between 18 and 24 years
* Body Mass Index (BMI) ≥ 30 kg/m²
* Signed informed consent

Exclusion Criteria:

* Pregnancy or expected pregnancy within the next month
* Women who are breastfeeding
* Diagnosed conditions such as: diabetes mellitus, hypertension, renal or hepatic insufficiency, infectious diseases, inflammatory diseases, or any neoplastic disease
* Conditions with dietary restrictions, such as celiac disease or history of gastric bypass surgery
* Active alcoholism with a daily intake exceeding 50 g/day
* Significant anticipated changes in diet or exercise within 15 days prior to the study's start
* History of drug or medication abuse
* Eating disorders
* Participation in any study involving investigational products within the 3 months prior to the start of the study
* Treatment with anti-inflammatory drugs, antibiotics, and/or antidepressants in the month prior to the study's start
* Consumption of nutraceuticals containing prebiotics, probiotics, or immunomodulators within 15 days prior to the study's start
* Individuals who choose to discontinue participation after the data collection process has started.
* Individuals who do not consent to the collection of any of the required samples (blood, diet, or stool) during the data collection phase.

Primary outcomes:
measure: Dietary Assessment
timeFrame: 1.5 years
measure: Dietary Inflammatory Index, DII
timeFrame: 1.5 years
measure: Dietary Inflammatory Potential, DIP
timeFrame: 1.5 years
Secondary outcomes:
measure: Inflammatory markers
timeFrame: 1.5 years
measure: C-reactive protein (CRP)
timeFrame: 1.5 years
measure: Intestinal microbiota
timeFrame: 1.5 years
measure: Height
timeFrame: 1.5 years
measure: Body weight
timeFrame: 1.5 years
measure: Body Mass Index (BMI)
timeFrame: 1.5 years
measure: Dual-Energy X-Ray Absorptiometry (DXA)
timeFrame: 1.5 years
measure: Bioelectrical Impedance Analysis (BIA)
timeFrame: 1.5 years
measure: Anxiety
timeFrame: 1.5 years
measure: Depression
timeFrame: 1.5 years
measure: Movement behavior
timeFrame: 1.5 years
measure: Food security
timeFrame: 1.5 years
Other outcomes:
Locations:
Study officials:
References:
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