NCT06971666

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Jun 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Jun 2025Jan 2027

First Submitted

Initial submission to the registry

January 20, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 14, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

June 20, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2027

Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

1.4 years

First QC Date

January 20, 2025

Last Update Submit

May 6, 2025

Conditions

Keywords

obesitydietary inflammatory potentialdietary inflammatory indexinflammatory markersgut microbiotaanxietydepression

Outcome Measures

Primary Outcomes (3)

  • 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.

    1.5 years

  • 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.

    1.5 years

  • 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

    1.5 years

Secondary Outcomes (12)

  • Inflammatory markers

    1.5 years

  • C-reactive protein (CRP)

    1.5 years

  • Intestinal microbiota

    1.5 years

  • Height

    1.5 years

  • Body weight

    1.5 years

  • +7 more secondary outcomes

Study Arms (1)

Observational, cross-sectional, analytical, and correlational

An observational, cross-sectional, analytical, and correlational study will be conducted on young individuals with obesity, diagnosed with Body Mass Index (BMI). The study aims to analyze the correlation between Dietary inflammatory potential (DIP), inflammatory markers, intestinal dysbiosis, exercise patterns, and the risk of anxiety and depression

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • Age between 18 and 24 years
  • Body Mass Index (BMI) ≥ 30 kg/m²
  • Signed informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Baltazar-Diaz TA, Gonzalez-Hernandez LA, Aldana-Ledesma JM, Pena-Rodriguez M, Vega-Magana AN, Zepeda-Morales ASM, Lopez-Roa RI, Del Toro-Arreola S, Martinez-Lopez E, Salazar-Montes AM, Bueno-Topete MR. Escherichia/Shigella, SCFAs, and Metabolic Pathways-The Triad That Orchestrates Intestinal Dysbiosis in Patients with Decompensated Alcoholic Cirrhosis from Western Mexico. Microorganisms. 2022 Jun 16;10(6):1231. doi: 10.3390/microorganisms10061231.

    PMID: 35744749BACKGROUND
  • Hadi S, Momenan M, Cheraghpour K, Hafizi N, Pourjavidi N, Malekahmadi M, Foroughi M, Alipour M. Abdominal volume index: a predictive measure in relationship between depression/anxiety and obesity. Afr Health Sci. 2020 Mar;20(1):257-265. doi: 10.4314/ahs.v20i1.31.

    PMID: 33402914BACKGROUND
  • Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

    PMID: 12900694BACKGROUND
  • Corley J, Shivappa N, Hebert JR, Starr JM, Deary IJ. Associations between Dietary Inflammatory Index Scores and Inflammatory Biomarkers among Older Adults in the Lothian Birth Cohort 1936 Study. J Nutr Health Aging. 2019;23(7):628-636. doi: 10.1007/s12603-019-1221-y.

    PMID: 31367727BACKGROUND
  • Cavicchia PP, Steck SE, Hurley TG, Hussey JR, Ma Y, Ockene IS, Hebert JR. A new dietary inflammatory index predicts interval changes in serum high-sensitivity C-reactive protein. J Nutr. 2009 Dec;139(12):2365-72. doi: 10.3945/jn.109.114025. Epub 2009 Oct 28.

    PMID: 19864399BACKGROUND
  • Boutens L, Hooiveld GJ, Dhingra S, Cramer RA, Netea MG, Stienstra R. Unique metabolic activation of adipose tissue macrophages in obesity promotes inflammatory responses. Diabetologia. 2018 Apr;61(4):942-953. doi: 10.1007/s00125-017-4526-6. Epub 2018 Jan 14.

    PMID: 29333574BACKGROUND
  • Amiri S, Behnezhad S. Obesity and anxiety symptoms: a systematic review and meta-analysis. Neuropsychiatr. 2019 Jun;33(2):72-89. doi: 10.1007/s40211-019-0302-9. Epub 2019 Feb 18.

    PMID: 30778841BACKGROUND
  • Almeida-de-Souza J, Santos R, Barros R, Abreu S, Moreira C, Lopes L, Mota J, Moreira P. Dietary inflammatory index and inflammatory biomarkers in adolescents from LabMed physical activity study. Eur J Clin Nutr. 2018 May;72(5):710-719. doi: 10.1038/s41430-017-0013-x. Epub 2017 Dec 26.

    PMID: 29277838BACKGROUND

MeSH Terms

Conditions

ObesityAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersBehavioral SymptomsBehavior

Central Study Contacts

Karla Janetté Nuño, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2025

First Posted

May 14, 2025

Study Start

June 20, 2025

Primary Completion (Estimated)

November 22, 2026

Study Completion (Estimated)

January 7, 2027

Last Updated

May 14, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

This is a project that involves data about patent