Dietary Inflammatory Potential in Young Pleople With Obesity
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-24
SponsorInstituto Tecnológico y de Estudios Superiores de Occidente
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Both sexes with no gender exclusion
Age between 18 and 24 years
Body Mass Index (BMI) ≥ 30 kg/m²
Signed informed consent
Disqualifiers
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
Trial 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.
Trial design
Design model
Case-crossover
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
170 Participants
are grouped into 1 trial groupGroup A: Observational, cross-sectional, analytical, and correlational
Trial outcomes
Primary outcomes
1
Dietary Assessment
Dietary intake will be estimated from a validated semiquantitative food frequency questionnaire (FFQ) that represents food consumption for the last 12 months. For each item, regular portion size will be established, and then frequencies of consumption will be available, ranging from "never" to "6 or more times/day". Energy and nutrient intakes will be obtained by multiplying the frequency by the serving size from Mexican food composition.
Time frame
1.5 years2
Dietary Inflammatory Index, DII
For the Dietary Inflammatory index, 45 food parameters related (positively or negatively) to inflammatory markers such as IL beta, IL4, IL6, IL10, TNF alpha, and CRP will be used. The score for each dietary parameter will be multiplied by each participant's intake, resulting in a numerical score ranging from -8 to +8.
Time frame
1.5 years3
Dietary Inflammatory Potential, DIP
The DIP will be obtained by analyzing the Dietary assessment and the Dietary Inflammatory Index intake, which will then be converted to a percentile score of 2 and subtracted by 1. The percentile score will be multiplied by the inflammatory effect score. All food parameters sill be summed to create the score. The score will be in quartiles: Q1, highly anti-inflammatory, Q2, anti-inflammatory, Q3, inflammatory; and Q4, highly inflammatory
Time frame
1.5 yearsSecondary outcomes
1
Inflammatory markers
For the determination of IL6, IL1 beta, IL10, and MCP-1 markers, a blood sample will be collected and then analyzed using the high-sensitivity ProQuantum™ technique. The assay workflow with one antibody incubation step prior to placing the plate in qPCR to determine levels of protein in picogram per milliliter, pg/mL.
Time frame
1.5 years2
C-reactive protein (CRP)
Determination of C-reactive protein levels will be determined by measuring the protein in a blood sample by visual agglutination. The results will be reported as positive or negative.
Time frame
1.5 years3
Intestinal microbiota
Analyses of intestinal microbiota will be performed by Rasmus sequencing on Illumina's MiSeq equipment. High-quality sequences will be classified into operational taxonomic units (OTUs) using the RDP database platform (Ribosomal Database Project) for the 16S rDNA gene with a bootstrap cutoff of 80%. Only OTUs representing more than 0.1% of the total sequences in each sample will be considered in subsequent statistical analyses.
Time frame
1.5 years4
Height
Height (mt) will be recorded. The technique extension requires the subject to stand with the feet apart at a 45° angle and the heels together, the posterior aspect of the buttocks, and the upper back resting on the stadiometer. The head should be in the Frankfort plane. The subject is asked to take a deep breath and hold it; the scorer places the square, triangular piece firmly over the vertex, squeezing the hair as tightly as possible. The measurement will be taken at the end of a deep breath.
Time frame
1.5 yearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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