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Effect of Weight Loss on Hepcidin Levels and Iron Status in Subjects With Obesity.

NCT06104800 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-04-21

No results posted yet for this study

Summary

Obesity and iron deficiency are the nutritional disorders with the highest prevalence worldwide. Different mechanisms have been proposed to explain iron deficiency secondary to obesity. Among the most studied is the deficit in dietary iron intake or the increase in blood volume that increases the need for the metal. However, one of the most plausible mechanisms linking obesity and iron deficiency is low-grade systemic inflammation, through the iron metabolism intermediate known as hepcidin. The investigators objective is to evaluate the effect of weight loss by caloric restriction on hepcidin and serum iron concentration in people living with obesity and iron deficiency. The study will be divided into two phases: Phase 1: A cross-sectional study (cases and controls) to compare hepcidin levels, iron status and inflammatory markers in people living with and without obesity. The second phase consists of an open-label randomized controlled clinical trial. Individuals living with obesity who are iron deficient will be recruited and randomized to one of 2 dietary intervention groups with 60-day follow-up. The intervention groups will be: diet with caloric restriction rich in protein (with red meat) and diet with caloric restriction rich in protein (without red meat). Hepcidin levels, iron status and inflammatory markers will be determined at the beginning and end of the intervention. The nutritional intervention will have the following distribution of macronutrients in the diet: protein 1.5 g/kg of ideal weight, 50% carbohydrates and 25-30% fats.

Conditions

Interventions

OTHER

Calorie-restricted diet with red meat

Calorie-restricted diet with macronutrient distribution: 1.5 g/kg of ideal body weight in protein (including red meat), 50% carbohydrates, and 25-30% fats.

OTHER

Calorie-restricted diet without red meat

Calorie-restricted diet with macronutrient distribution: 1.5 g/kg of ideal body weight in protein (excluding red meat), 50% carbohydrates, and 25-30% fats

Sponsors & Collaborators

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    lead OTHER

Principal Investigators

  • Martha Guevara-Cruz, MD, PhD · Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-08
Primary Completion
2024-04-30
Completion
2025-01-24

Countries

  • Mexico

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06104800 on ClinicalTrials.gov