ObesityNCT06104800
Effect of Weight Loss on Hepcidin Levels and Iron Status in Subjects With Obesity.
A study testing Calorie-restricted diet with red meat and Calorie-restricted diet without red meat in people with Obesity and Iron Deficiency Anemia, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Iron Deficiency Anemia
- What is being tested?
- Calorie-restricted diet with red meat and Calorie-restricted diet without red meat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteMexico
- Study dates
- 8 Jan 2024to 24 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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).
Who cannot join
- 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.
Show all 23Show fewer
- Pregnancy.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
México
About this study
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.
Read the detailed description
The study will consist of two phases: Phase 1, which will be cross-sectional, and Phase 2, which will involve a randomized controlled clinical trial.
Phase 1: Cross-Sectional Study A cross-sectional study will be conducted to compare hepcidin levels, iron status and inflammatory markers in people living with and without obesity. Upon obtaining signed consent, participants will undergo a medical history assessment, anthropometric measurements (weight, height, waist circumference), body composition analysis (% body fat, % skeletal muscle mass, % fat-free mass), and blood samples will be collected to determine serum hepcidin levels, iron status, inflammatory markers (C-reactive protein, interleukin-6, lipopolysaccharides), and oxidative stress markers (MDA).
Additional blood samples will be taken for biochemical tests (glucose, lipid profile, creatinine, urea, liver function tests), insulin, leptin, adiponectin, and, optionally, DNA isolation for polymorphisms determination and those associated with iron metabolism and obesity. Participants will also complete a food frequency questionnaire (SNUT).
Phase 2: Open randomized controlled clinical trial This phase will be conducted to assess the impact of weight loss on hepcidin levels, iron status, and inflammatory markers in individuals living with obesity. Participants recruited for this phase will be selected from those identified in the first phase who exhibit iron deficiency (serum iron < 50 mcg/dL).
Participants will be randomly assigned to one of two dietary intervention groups, both of which will undergo a 60-day follow-up period with a calorie-restricted diet, reducing caloric intake by less than 25% of the resting energy expenditure determined by indirect calorimetry. The intervention groups will be as follows:
- 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 with macronutrient distribution: 1.5 g/kg of ideal body weight in protein (excluding red meat), 50% carbohydrates, and 25-30% fats.
Additionally, all participants will receive ferrous sulfate 200mg every 48 hours for three months to correct iron-deficiency anemia.
During the initial and final visits, participants will undergo a 24-hour dietary recall, complete a physical activity questionnaire, and fill out a quality-of-life questionnaire. Additionally, anthropometric measurements and body composition analysis will be conducted. Blood samples will be collected to determine various biochemical parameters in the blood, including lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides), liver function tests, glucose, insulin, creatinine, urea, oxidative stress markers, inflammatory markers (C-reactive protein and lipopolysaccharides), and iron status markers. Furthermore, stool samples will be collected to analyze the composition of the intestinal microbiota and metabolomics.
To assess treatment adherence, participants will be provided with a food logs to record their daily food consumption during the initial visit. The participants will also receive a pantry containing protein-rich foods every week to facilitate the nutritional intervention. Also, 2 phone calls will be made each week to evaluate adherence to treatment. The adherence will be determined with the % of adherence to the dietary treatment as obtained in the analysis of the food logs.
- Conditions
- Obesity, Iron Deficiency Anemia
- Being tested
- Calorie-restricted diet with red meat, Calorie-restricted diet without red meat
- Medical subject headings
- Obesity, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Red meat diet | Experimental | 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. Receives: Other: Calorie-restricted diet with red meat |
| Red meat free diet | Active comparator | 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 Receives: Other: Calorie-restricted diet without red meat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum iron concentration in mcg/dL
Change in serum iron concentration between different nutritional interventions in subjects with obesity and iron deficiency
Measured: Baseline to 2 months of intervention
Serum hepcidin concentration in mcg/dL
Change in serum hepcidin concentration between different nutritional interventions in subjects with obesity and iron deficiency
Measured: Baseline to 2 months of intervention
Secondary outcomes (23)
Serum ferritin concentration in ng/mL
Change in serum ferritin concentration between different nutritional interventions in subjects with obesity and iron deficiency
Measured: Baseline to 2 months of intervention
Serum iron binding capacity concentration in mcg/dL
Change in serum iron binding capacity concentration between different nutritional interventions in subjects with obesity and iron deficiency
Measured: Baseline to 2 months of intervention
Blood reticulocytes percentage
Change in blood reticulocytes percentage between different nutritional interventions in subjects with obesity and iron deficiency
Measured: Baseline to 2 months of intervention
Serum soluble transferrin receptor concentration in mg/L.
Change in serum soluble transferrin receptor concentration between different nutritional interventions in subjects with obesity and iron deficiency
Measured: Baseline to 2 months of intervention
Blood haemoglobin concentration in g/dL
Change in blood haemoglobin concentration between different nutritional interventions in subjects with obesity and iron deficiency
Measured: Baseline to 2 months of intervention
Serum C-reactive protein concentration in g/dL
Change in C-reactive protein concentration between different nutritional interventions in subjects with obesity and iron deficiency
Measured: Baseline to 2 months of intervention
Serum leptin concentration in ng/mL
Change in leptin concentration in the serum determined by ELISA kit between different nutritional interventions in subjects with obesity and iron deficiency
Measured: Baseline to 2 months of intervention
Serum interleukin 6 concentration in pg/mL
Change in interleukin-6 concentration determined by ELISA kit between different nutritional interventions in subjects with obesity and iron deficiency
Measured: Baseline to 2 months of intervention
Serum lipopolysaccharides concentration in ng/mL
Change in lipopolysaccharides concentration between different nutritional interventions in subjects with obesity and iron deficiency
Measured: Baseline to 2 months of intervention
Plasma malondialdehyde concentration in nmol/mL
Change in malondialdehyde concentration by spectrophotometry between different nutritional interventions in subjects with obesity and iron deficiency
Measured: Baseline to 2 months of intervention
Plasma trolox equivalents concentration in umols/mL
Change in trolox equivalents concentration between different nutritional interventions in subjects with obesity and iron deficiency
Measured: Baseline to 2 months of intervention
Changes in faecal microbiota composition
The change in faecal microbiota composition shall be measured by 16 ribosome sequencing at baseline and at 2 months. The relative change of each bacterial taxon shall be calculated on the basis of the abundance of the given bacteria at baseline to 2 months between different nutritional interventions in subjects with obesity and iron deficiency
Measured: Baseline to 2 months of intervention
Serum total cholesterol concentration in mg/dL
Change in total cholesterol concentration determined by autoanalyzer between different nutritional interventions in subjects with obesity and iron deficiency
Measured: Baseline to 2 months of intervention
Serum LDL cholesterol concentration in mg/dL
Change in LDL-cholesterol concentration determined by autoanalyzer between different nutritional interventions in subjects with obesity and iron deficiency
Measured: Baseline to 2 months of intervention
Serum triglycerides concentration in mg/dL
Change in triglycerides concentration determined by autoanalyzer between different nutritional interventions in subjects with obesity and iron deficiency
Measured: Baseline to 2 months of intervention
Serum aspartate aminotransferase concentration in IU/mL
Change in aspartate aminotransferase concentration determined by autoanalyzer between different nutritional interventions in subjects with obesity and iron deficiency
Measured: Baseline to 2 months of intervention
Serum alanine aminotransferase concentration in IU/mL
Change in alanine aminotransferase concentration determined by autoanalyzer between different nutritional interventions in subjects with obesity and iron deficiency
Measured: Baseline to 2 months of intervention
Serum glucose concentration in mg/dL
Change in serum glucose concentration determined by autoanalyzer between different nutritional interventions in subjects with obesity and iron deficiency
Measured: Baseline to 2 months of intervention
Body weight in kilograms
Change in body weight between different nutritional interventions in subjects with obesity and iron deficiency
Measured: Baseline to 2 months of intervention
Fat mass percentage
Change in fat mass percentage determined by multifrequency electrical bioimpedance between different nutritional interventions in subjects with obesity and iron deficiency
Measured: Baseline to 2 months of intervention
Waist circumference in centimeters
Change in waist circumference between different nutritional interventions in subjects with obesity and iron deficiency
Measured: Baseline to 2 months of intervention
Lean mass percentage
Change in fat mass percentage determined by multifrequency electrical bioimpedance between different nutritional interventions in subjects with obesity and iron deficiency
Measured: Baseline to 2 months of intervention
Skeletal muscle mass percentage
Change in fat mass percentage determined by multifrequency electrical bioimpedance between different nutritional interventions in subjects with obesity and iron deficiency
Measured: Baseline to 2 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start8 Jan 2024
- Primary completion30 Apr 2024
- Study completion24 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The groups will receive the treatment simultaneously.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martha Guevara Cruz, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Investigators
- Martha Guevara-Cruz, MD, PhD, Principal investigator, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104800
- Sponsor's protocol ID
- FNU-4686-23-24-1
- Status last verified
- Apr 2026
- First submitted
- 18 Oct 2023
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou Z, Zhang H, Chen K, Liu C. Iron status and obesity-related traits: A two-sample bidirectional Mendelian randomization study. Front Endocrinol (Lausanne). 2023 Feb 14;14:985338. doi: 10.3389/fendo.2023.985338. eCollection 2023.
PubMed 36864839Yanoff LB, Menzie CM, Denkinger B, Sebring NG, McHugh T, Remaley AT, Yanovski JA. Inflammation and iron deficiency in the hypoferremia of obesity. Int J Obes (Lond). 2007 Sep;31(9):1412-9. doi: 10.1038/sj.ijo.0803625. Epub 2007 Apr 17.
PubMed 17438557Becker C, Schumann K. Iron-homeostasis and obesity. J Trace Elem Med Biol. 2015 Apr;30:194. doi: 10.1016/j.jtemb.2014.06.009. Epub 2014 Jun 27. No abstract available.
PubMed 25023846Coimbra S, Catarino C, Santos-Silva A. The role of adipocytes in the modulation of iron metabolism in obesity. Obes Rev. 2013 Oct;14(10):771-9. doi: 10.1111/obr.12057. Epub 2013 Jul 11.
PubMed 23841713Collins JF, Wessling-Resnick M, Knutson MD. Hepcidin regulation of iron transport. J Nutr. 2008 Nov;138(11):2284-8. doi: 10.3945/jn.108.096347.
PubMed 18936232Anderson GJ, Frazer DM. Current understanding of iron homeostasis. Am J Clin Nutr. 2017 Dec;106(Suppl 6):1559S-1566S. doi: 10.3945/ajcn.117.155804. Epub 2017 Oct 25.
PubMed 29070551Ross AC. Impact of chronic and acute inflammation on extra- and intracellular iron homeostasis. Am J Clin Nutr. 2017 Dec;106(Suppl 6):1581S-1587S. doi: 10.3945/ajcn.117.155838. Epub 2017 Oct 25.
PubMed 29070546Joffin N, Gliniak CM, Funcke JB, Paschoal VA, Crewe C, Chen S, Gordillo R, Kusminski CM, Oh DY, Geldenhuys WJ, Scherer PE. Adipose tissue macrophages exert systemic metabolic control by manipulating local iron concentrations. Nat Metab. 2022 Nov;4(11):1474-1494. doi: 10.1038/s42255-022-00664-z. Epub 2022 Nov 3.
PubMed 36329217Gabrielsen JS, Gao Y, Simcox JA, Huang J, Thorup D, Jones D, Cooksey RC, Gabrielsen D, Adams TD, Hunt SC, Hopkins PN, Cefalu WT, McClain DA. Adipocyte iron regulates adiponectin and insulin sensitivity. J Clin Invest. 2012 Oct;122(10):3529-40. doi: 10.1172/JCI44421. Epub 2012 Sep 10.
PubMed 22996660Moreto F, de Oliveira EP, Manda RM, Burini RC. The higher plasma malondialdehyde concentrations are determined by metabolic syndrome-related glucolipotoxicity. Oxid Med Cell Longev. 2014;2014:505368. doi: 10.1155/2014/505368. Epub 2014 Jun 24.
PubMed 25089170Nikonorov AA, Skalnaya MG, Tinkov AA, Skalny AV. Mutual interaction between iron homeostasis and obesity pathogenesis. J Trace Elem Med Biol. 2015 Apr;30:207-14. doi: 10.1016/j.jtemb.2014.05.005. Epub 2014 May 24.
PubMed 24916791Teng IC, Tseng SH, Aulia B, Shih CK, Bai CH, Chang JS. Can diet-induced weight loss improve iron homoeostasis in patients with obesity: A systematic review and meta-analysis. Obes Rev. 2020 Dec;21(12):e13080. doi: 10.1111/obr.13080. Epub 2020 Jul 16.
PubMed 32677171Abbaspour N, Hurrell R, Kelishadi R. Review on iron and its importance for human health. J Res Med Sci. 2014 Feb;19(2):164-74.
PubMed 24778671Dev S, Babitt JL. Overview of iron metabolism in health and disease. Hemodial Int. 2017 Jun;21 Suppl 1(Suppl 1):S6-S20. doi: 10.1111/hdi.12542. Epub 2017 Mar 15.
PubMed 28296010Zhang C, Rawal S. Dietary iron intake, iron status, and gestational diabetes. Am J Clin Nutr. 2017 Dec;106(Suppl 6):1672S-1680S. doi: 10.3945/ajcn.117.156034. Epub 2017 Oct 25.
PubMed 29070554
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Weight Loss on Hepcidin Levels and Iron Status in Subjects With Obesity.
- ClinicalTrials.gov ID
- NCT06104800
- Acronym / sponsor ID
- FNU-4686-23-24-1
- Conditions
- Obesity, Iron Deficiency Anemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 24 Jan 2025 (actual)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will consist of two phases: Phase 1, which will be cross-sectional, and Phase 2, which will involve a randomized controlled clinical trial.
Phase 1: Cross-Sectional Study A cross-sectional study will be conducted to compare hepcidin levels, iron status and inflammatory markers in people living with and without obesity. Upon obtaining signed consent, participants will undergo a medical history assessment, anthropometric measurements (weight, height, waist circumference), body composition analysis (% body fat, % skeletal muscle mass, % fat-free mass), and blood samples will be collected to determine serum hepcidin levels, iron status, inflammatory markers (C-reactive protein, interleukin-6, lipopolysaccharides), and oxidative stress markers (MDA).
Additional blood samples will be taken for biochemical tests (glucose, lipid profile, creatinine, urea, liver function tests), insulin, leptin, adiponectin, and, optionally, DNA isolation for polymorphisms determination and those associated with iron metabolism and obesity. Participants will also complete a food frequency questionnaire (SNUT).
Phase 2: Open randomized controlled clinical trial This phase will be conducted to assess the impact of weight loss on hepcidin levels, iron status, and inflammatory markers in individuals living with obesity. Participants recruited for this phase will be selected from those identified in the first phase who exhibit iron deficiency (serum iron < 50 mcg/dL).
Participants will be randomly assigned to one of two dietary intervention groups, both of which will undergo a 60-day follow-up period with a calorie-restricted diet, reducing caloric intake by less than 25% of the resting energy expenditure determined by indirect calorimetry. The intervention groups will be as follows:
- 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 with macronutrient distribution: 1.5 g/kg of ideal body weight in protein (excluding red meat), 50% carbohydrates, and 25-30% fats.
Additionally, all participants will receive ferrous sulfate 200mg every 48 hours for three months to correct iron-deficiency anemia.
During the initial and final visits, participants will undergo a 24-hour dietary recall, complete a physical activity questionnaire, and fill out a quality-of-life questionnaire. Additionally, anthropometric measurements and body composition analysis will be conducted. Blood samples will be collected to determine various biochemical parameters in the blood, including lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides), liver function tests, glucose, insulin, creatinine, urea, oxidative stress markers, inflammatory markers (C-reactive protein and lipopolysaccharides), and iron status markers. Furthermore, stool samples will be collected to analyze the composition of the intestinal microbiota and metabolomics.
To assess treatment adherence, participants will be provided with a food logs to record their daily food consumption during the initial visit. The participants will also receive a pantry containing protein-rich foods every week to facilitate the nutritional intervention. Also, 2 phone calls will be made each week to evaluate adherence to treatment. The adherence will be determined with the % of adherence to the dietary treatment as obtained in the analysis of the food logs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The groups will receive the treatment simultaneously.
| Arm | Type | Receives |
|---|---|---|
| Red meat diet | Experimental | Other: Calorie-restricted diet with red meatCalorie-restricted diet with macronutrient distribution: 1.5 g/kg of ideal body weight in protein (including red meat), 50% carbohydrates, and 25-30% fats. |
| Red meat free diet | Active comparator | Other: Calorie-restricted diet without red meatCalorie-restricted diet with macronutrient distribution: 1.5 g/kg of ideal body weight in protein (excluding red meat), 50% carbohydrates, and 25-30% fats |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calorie-restricted diet with red meatCalorie-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 | Red meat diet |
| Calorie-restricted diet without red meatCalorie-restricted diet with macronutrient distribution: 1.5 g/kg of ideal body weight in protein (excluding red meat), 50% carbohydrates, and 25-30% fats | Other | Red meat free diet |
Primary outcome
Serum iron concentration in mcg/dL
Time frame: Baseline to 2 months of intervention
Change in serum iron concentration between different nutritional interventions in subjects with obesity and iron deficiency
Serum hepcidin concentration in mcg/dL
Time frame: Baseline to 2 months of intervention
Change in serum hepcidin concentration between different nutritional interventions in subjects with obesity and iron deficiency
23 secondary outcomes
Serum ferritin concentration in ng/mL
Time frame: Baseline to 2 months of intervention
Serum iron binding capacity concentration in mcg/dL
Time frame: Baseline to 2 months of intervention
Blood reticulocytes percentage
Time frame: Baseline to 2 months of intervention
Serum soluble transferrin receptor concentration in mg/L.
Time frame: Baseline to 2 months of intervention
Blood haemoglobin concentration in g/dL
Time frame: Baseline to 2 months of intervention
Serum C-reactive protein concentration in g/dL
Time frame: Baseline to 2 months of intervention
Serum leptin concentration in ng/mL
Time frame: Baseline to 2 months of intervention
Serum interleukin 6 concentration in pg/mL
Time frame: Baseline to 2 months of intervention
Serum lipopolysaccharides concentration in ng/mL
Time frame: Baseline to 2 months of intervention
Plasma malondialdehyde concentration in nmol/mL
Time frame: Baseline to 2 months of intervention
Plasma trolox equivalents concentration in umols/mL
Time frame: Baseline to 2 months of intervention
Changes in faecal microbiota composition
Time frame: Baseline to 2 months of intervention
Serum total cholesterol concentration in mg/dL
Time frame: Baseline to 2 months of intervention
Serum LDL cholesterol concentration in mg/dL
Time frame: Baseline to 2 months of intervention
Serum triglycerides concentration in mg/dL
Time frame: Baseline to 2 months of intervention
Serum aspartate aminotransferase concentration in IU/mL
Time frame: Baseline to 2 months of intervention
Serum alanine aminotransferase concentration in IU/mL
Time frame: Baseline to 2 months of intervention
Serum glucose concentration in mg/dL
Time frame: Baseline to 2 months of intervention
Body weight in kilograms
Time frame: Baseline to 2 months of intervention
Fat mass percentage
Time frame: Baseline to 2 months of intervention
Waist circumference in centimeters
Time frame: Baseline to 2 months of intervention
Lean mass percentage
Time frame: Baseline to 2 months of intervention
Skeletal muscle mass percentage
Time frame: Baseline to 2 months of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Background: PubMed 36864839Zhou Z, Zhang H, Chen K, Liu C. Iron status and obesity-related traits: A two-sample bidirectional Mendelian randomization study. Front Endocrinol (Lausanne). 2023 Feb 14;14:985338. doi: 10.3389/fendo.2023.985338. eCollection 2023.
- Background: PubMed 17438557Yanoff LB, Menzie CM, Denkinger B, Sebring NG, McHugh T, Remaley AT, Yanovski JA. Inflammation and iron deficiency in the hypoferremia of obesity. Int J Obes (Lond). 2007 Sep;31(9):1412-9. doi: 10.1038/sj.ijo.0803625. Epub 2007 Apr 17.
- Background: PubMed 25023846Becker C, Schumann K. Iron-homeostasis and obesity. J Trace Elem Med Biol. 2015 Apr;30:194. doi: 10.1016/j.jtemb.2014.06.009. Epub 2014 Jun 27. No abstract available.
- Background: PubMed 23841713Coimbra S, Catarino C, Santos-Silva A. The role of adipocytes in the modulation of iron metabolism in obesity. Obes Rev. 2013 Oct;14(10):771-9. doi: 10.1111/obr.12057. Epub 2013 Jul 11.
- Background: PubMed 18936232Collins JF, Wessling-Resnick M, Knutson MD. Hepcidin regulation of iron transport. J Nutr. 2008 Nov;138(11):2284-8. doi: 10.3945/jn.108.096347.
- Background: PubMed 29070551Anderson GJ, Frazer DM. Current understanding of iron homeostasis. Am J Clin Nutr. 2017 Dec;106(Suppl 6):1559S-1566S. doi: 10.3945/ajcn.117.155804. Epub 2017 Oct 25.
- Background: PubMed 29070546Ross AC. Impact of chronic and acute inflammation on extra- and intracellular iron homeostasis. Am J Clin Nutr. 2017 Dec;106(Suppl 6):1581S-1587S. doi: 10.3945/ajcn.117.155838. Epub 2017 Oct 25.
- Background: PubMed 36329217Joffin N, Gliniak CM, Funcke JB, Paschoal VA, Crewe C, Chen S, Gordillo R, Kusminski CM, Oh DY, Geldenhuys WJ, Scherer PE. Adipose tissue macrophages exert systemic metabolic control by manipulating local iron concentrations. Nat Metab. 2022 Nov;4(11):1474-1494. doi: 10.1038/s42255-022-00664-z. Epub 2022 Nov 3.
- Background: PubMed 22996660Gabrielsen JS, Gao Y, Simcox JA, Huang J, Thorup D, Jones D, Cooksey RC, Gabrielsen D, Adams TD, Hunt SC, Hopkins PN, Cefalu WT, McClain DA. Adipocyte iron regulates adiponectin and insulin sensitivity. J Clin Invest. 2012 Oct;122(10):3529-40. doi: 10.1172/JCI44421. Epub 2012 Sep 10.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha Guevara-Cruz, MD, PhD principal investigator
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calorie-restricted diet with red meat and Calorie-restricted diet without red meat in people with Obesity and Iron Deficiency Anemia, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum iron concentration in mcg/dL (time frame: Baseline to 2 months of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06104800, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.