Meals to Improve Absorption of Iron Supplements

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

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.

Study Overview

• Status: Completed
• Conditions: Iron-deficiency; Iron Deficiency Anemia; Iron Deficiency Anemia Treatment
• Intervention / Treatment: Other: Iron supplement with a lunch meal containing beef; Other: Iron supplement with a lunch meal containing plant-based alternative

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2021
• Primary Completion (Actual): November 1, 2024
• Study Completion (Actual): November 1, 2024

Study Registration Dates

• First Submitted: March 3, 2021
• First Submitted That Met QC Criteria: March 9, 2021
• First Posted (Actual): March 11, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Metabolic Diseases; Hematologic Diseases; Iron Metabolism Disorders; Anemia, Hypochromic; Malnutrition; Iron Deficiencies; Anemia; Anemia, Iron-Deficiency; Deficiency Diseases; Physiological Effects of Drugs; Trace Elements; Micronutrients; Iron
• Other Study ID Numbers: PBRC 2022-036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No