CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 42 enrolled
Drug / intervention
Calorie-restricted diet with red meat +1 moreother
Likely dose
Not stated in record
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Search/NCT06104800
NCT06104800N/ACompleted

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

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran·interventional·Posted Oct 27, 2023·Updated Apr 21, 2026

In Brief

A clinical study evaluating Calorie-restricted diet with red meat and Calorie-restricted diet without red meat for Obesity and Iron Deficiency Anemia. Completed, enrolled 42 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMexico
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedOct 27, 2023
Enrollment StartJan 8, 2024
Primary CompletionApr 30, 2024
Study CompletionJan 24, 2025
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 2.7 years ago

Interventions

Calorie-restricted diet with red meatother

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.

Calorie-restricted diet without red meatother

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