NCT06104800Completed
Effect of Weight Loss on Hepcidin Levels and Iron Status in Subjects With Obesity.
Source: ClinicalTrials.gov · Last updated 21 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 42 (actual)
- First submitted
- 18 Oct 2023
- Start date
- 8 Jan 2024
- Primary completion date
- 30 Apr 2024
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Diseases
- Obesity
- NCT number
- NCT06104800
What you commit to
- Study type: Interventional
- Participants enrolled: 42
- From 8 Jan 2024 to the primary completion date, 30 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any type of diabetes.
- Patients with renal disease diagnosed by a physician.
- Patients with acquired diseases that secondarily produce obesity and diabetes.
- Patients with catabolic diseases such as cancer and acquired immunodeficiency syndrome.
- Patients who have suffered a blood loss of more than 500 ml or recent gastrointestinal tract perforation.
- Allergy or intolerance to any food mentioned in the proposed pantry such as egg, dairy, fish, tuna, chicken, beans, lima beans and/or lentils.
Lab values
- Treatment with any drug treatment:
- 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).
- Treatment with hypoglycemic agents (sulfonylureas, biguanides, incretins) or insulin and antidiabetics.
- Treatment with statins, fibrates or other drugs to control dyslipidemia.
- Use of steroid drugs, chemotherapy, immunosuppressants or radiotherapy.
- Anorectics or drugs that accelerate weight loss.
- Any drug or medication that activates intestinal motility (cisapride, dimethicone, domperidone, metoclopramide, trimebutine).
- Laxatives or antispasmodics 4 weeks prior to the study h) Antibiotic treatment 2 months prior to the study.
- Treatment with any medication that influences inflammation or iron metabolism (proton pump inhibitors, antacids, bisphosphonates, bile acid or calcium sequestrants).
Other
- Patients who have suffered a cardiovascular event.
- Weight loss \> 3 kg in the last 3 months.
- Pregnancy.
- 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.
- Patients who are vegetarians
- Unwillingness to consume any of the foods listed in the proposed pantry.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Coordinator of this site? Confirm its status | México | Mexico | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.