💬In plain words
What the trial is, and whether it could suit you
Obese people typically have chronic low-grade inflammation. Based on short-term studies, this inflammation could affect the absorption, utilization, storage, and mobilization of iron, and individuals with inflammation might develop iron deficiency (ID) and anemia when inadequacy of iron intake is presented. The double burden of malnutrition is nowadays emerging as a major public health concern in many countries, including Thailand. Understanding the association of chronic inflammation among people with overweight or obesity (OW/OB) with long-term iron absorption and loss is important for developing appropriate policies and programs to promote iron balance and, consequently, optimal iron status and health outcomes. Since previous reports among Thai women showed a high prevalence of OW/OB and anemia, this study will be conducted to determine the long-term iron absorption and loss among OW/
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📋 Eligibility rules (as published)
Inclusion Criteria:
* Normal weight group
1. Aged 40-50 years
2. Normal weight (BMI 18.5-22.9 kg/m²)
3. Hb ≥12.0 g/dL and inflammation-adjusted SFa \<50.0 µg/L
4. CRP \<5.0 mg/L
5. Normal hemoglobin typing
6. Plans to reside in the study area for \>2 years
* Overweight/obese group
1. Aged 40-50 years
2. Overweight or obese \[Body Mass Index (BMI) ≥25.0 kg/m²\] - the BMI cut-off follows the agreement of countries under the Coordinated Research Project (CRP) E43038 "Using the iron isotope dilution technique to assess the influence of inflammation on long-term iron absorption and loss," supported by the IAEA
3. Hemoglobin (Hb) ≥12.0 g/dL and inflammation-adjusted serum ferritin (SFa) \<50.0 µg/L
4. C-reactive protein (CRP) between 5.0-25.0 mg/L
5. Normal hemoglobin typing
6. Plans to reside in the study area for \>2 years
Exclusion Criteria:
* Normal weight group
1. Having serious medical conditions such as cancer, chronic kidney disease, chronic liver disease, or chronic heart failure
2. Having metabolic NCDs (e.g., diabetes, hyperlipidemia, hypertension) requiring hospitalization
3. Pregnant, breastfeeding, or planning pregnancy during the study
4. Chronic infectious disease (e.g., tuberculosis, AIDS)
5. Regular use of anti-inflammatory or other medications (except contraceptives and acne medication)
6. Taking vitamin or mineral supplements during or within two weeks prior to the study
7. Participating in a weight-loss program
8. Known intolerance to iron supplements (e.g., vomiting, diarrhea, abdominal pain, bloating, nausea, or allergic reactions such as rash, breathing difficulty, chest tightness, facial or lip swelling)
9. Blood transfusion, blood donation, or significant blood loss during the study or within 6 months before enrollment
10. Heavy menstrual bleeding (\>80 mL/day, calculated from menstrual record)
* Overweight/obese group
1. Obesity class II (BMI ≥35.0 kg/m²) with high health risk
2. Having serious medical conditions such as cancer, chronic kidney disease, chronic liver disease, or chronic heart failure
3. Having metabolic noncommunicable diseases (e.g., diabetes, hyperlipidemia, hypertension) requiring hospitalization
4. Pregnant, breastfeeding, or planning pregnancy during the study
5. Chronic infectious disease (e.g., tuberculosis, AIDS)
6. Regular use of anti-inflammatory or other medications (except contraceptives and acne medication)
7. Taking vitamin or mineral supplements during or within two weeks prior to the study
8. Participating in a weight-loss program
9. Known intolerance to iron supplements (e.g., vomiting, diarrhea, abdominal pain, bloating, nausea, or allergic reactions such as rash, breathing difficulty, chest tightness, facial or lip swelling)
10. Blood transfusion, blood donation, or significant blood loss during the study or within 6 months before enrollment
11. Heavy menstrual bleeding (\>80 mL/day, calculated from menstrual record)
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