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NCT06104800

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

Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-01-08

Completion Date

2025-01-24

Last Updated

2026-04-21

Healthy Volunteers

Yes

Conditions

Obesity Iron Deficiency Anemia

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

Inclusion Criteria: Phase 1 * Signing of the informed consent form * Both sexes * Adults over 18 years of age * BMI of 18.5 and under 40 kg/m2 Phase 2 * Both sexes * Adults older than 18 years * People with obesity (BMI of 30 to 40 kg/m2) and serum iron \< 50 micrograms/dL. * Total cholesterol less than 240 mg/dL (with the diet plan 20% decrease). Exclusion Criteria: * Any type of diabetes. * Patients with renal disease diagnosed by a physician. * Patients with acquired diseases that secondarily produce obesity and diabetes. * Patients who have suffered a cardiovascular event. * Weight loss \> 3 kg in the last 3 months. * Patients with catabolic diseases such as cancer and acquired immunodeficiency syndrome. * Pregnancy. * Treatment with any drug treatment: 1. Treatment with antihypertensive drugs (loop or potassium-sparing diuretics, angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin II receptor blockers, alpha blockers, calcium antagonists, beta blockers). 2. Treatment with hypoglycemic agents (sulfonylureas, biguanides, incretins) or insulin and antidiabetics. 3. Treatment with statins, fibrates or other drugs to control dyslipidemia. 4. Use of steroid drugs, chemotherapy, immunosuppressants or radiotherapy. 5. Anorectics or drugs that accelerate weight loss. 6. Any drug or medication that activates intestinal motility (cisapride, dimethicone, domperidone, metoclopramide, trimebutine). 7. Laxatives or antispasmodics 4 weeks prior to the study h) Antibiotic treatment 2 months prior to the study. * Patients who have suffered a blood loss of more than 500 ml or recent gastrointestinal tract perforation. * Patients with a smoking index greater than 21. * Consumption of large amounts of alcohol (14 drinks for women or 21 drinks for men in a normal week). * Consumption of any recreational psychoactive substance. * Treatment with any medication that influences inflammation or iron metabolism (proton pump inhibitors, antacids, bisphosphonates, bile acid or calcium sequestrants). * Patients who are vegetarians * Allergy or intolerance to any food mentioned in the proposed pantry such as egg, dairy, fish, tuna, chicken, beans, lima beans and/or lentils. * Unwillingness to consume any of the foods listed in the proposed pantry.

Locations (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

México, Mexico