Meals to Improve Absorption of Iron Supplements

Study Overview
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Brief Summary
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One of the targeted objectives of Healthy People 2020 is to reduce iron deficiency among women of reproductive age (WRA). Consuming foods rich in iron and/or oral iron supplementation is typically recommended to improve iron status; however, global rates of iron deficiency remain high. Thus, nutritional strategies to improve/maintain iron status are warranted. Dietary iron is found in two different forms: heme and non-heme iron. Non-heme iron is found in plant-based sources and is commonly used as a supplement and food fortificant. Absorption of non-heme iron is low compared to heme iron, which is found in animal sources, such as beef. Studies have also demonstrated that beef contains an unidentified factor that stimulates the absorption of non-heme iron. The primary objective of the proposed study is to determine the effects of incorporating daily meals containing beef or plant-based alternative with or without an iron supplement on indicators of iron status in iron-deficient WRA.

Official Title
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Meals to Improve Absorption of Iron Supplements and Iron Status in Iron Deficient Women of Reproductive Age: a Randomized, Controlled Trial

Conditions
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Iron-deficiency, Iron Deficiency Anemia, Iron Deficiency Anemia Treatment

Intervention / Treatment
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* Other: Iron supplement with a lunch meal containing beef
* Other: Iron supplement with a lunch meal containing plant-based alternative


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI) falls within the normal weight or overweight range (18.5-29.9 kg/m^2) Low iron stores (serum ferritin <25 μg/L) Willing to refrain from smoking and >2 alcoholic drinks/week for the duration of the study period Willing to refrain from vitamin and mineral supplementation for the duration of the study Exclusion Criteria: Currently smoking or vaping Currently taking a medication that interferes with micronutrient metabolism Unwilling to refrain from vitamin and mineral supplementation for the duration of the study Restrictive diets (i.e., vegan or vegetarian diets) Metabolic or cardiovascular abnormalities (e.g., kidney disease, diabetes, cardiovascular disease, etc.) History of any disease or abnormality of the gastrointestinal tract including, but not limited to, diverticulosis, diverticulitis and inflammatory bowel disease, peptic ulcer disease, Crohn's disease, ulcerative colitis; or previous gastrointestinal surgery Blood donation within 4 months of beginning the study Abnormal blood clotting

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Beef<br> | Other: Iron supplement with a lunch meal containing beef<br>* Participants will consume a lunch meal containing beef with an iron supplement for 8 weeks.<br>|
| Experimental: Plant-based alternative<br> | Other: Iron supplement with a lunch meal containing plant-based alternative<br>* Participants will consume a lunch meal containing plant-based alternative with an iron supplement for 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Iron status | Plasma ferritin, soluble transferrin receptor, transferrin saturation, hemoglobin and hematocrit will be measured to determine iron status. Changes in measures of iron status during the intervention will be compared between groups. | Change from day 0 and day 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Profile of Mood States (POMS) | The POMS questionnaire will be used to assess the overall mood state of the participants. Changes in the POMS during the intervention will be compared between groups. | Change from day 0 and day 56 | 
| Appetite | Subjective appetite and satiety will be assessed before and after the lunch meal using visual analog scales. | Change from day 0 and day 56 | 
| Weight | Changes in body weight during the intervention will be compared between groups. | Change from day 0 and day 56 | 
| Body composition | Body composition (fat mass, fat-free mass, and total body water content) will be determined using single frequency bioimpedance spectroscopy (BIS). Changes in body composition during the intervention will be compared between groups. | Change from day 0 and day 56 | 
| Blood pressure | Changes in blood pressure during the intervention will be compared between groups. | Change from day 0 and day 56 | 
| Metabolic biomarkers | Changes in blood lipids, glucose, and insulin during the intervention will be compared between groups. | Change from day 0 and day 56 | 
| Plasma zinc | Changes in the plasma zinc during the intervention will be compared between groups. | Change from day 0 and day 56 | 
| Plasma vitamin B-12 | Changes in the plasma vitamin B-12 during the intervention will be compared between groups. | Change from day 0 and day 56 | 
| Plasma choline | Changes in the plasma choline during the intervention will be compared between groups. | Change from day 0 and day 56 |