Meals to Improve Absorption of Iron Supplements

NCT04793906 | Completed

• 1 other identifier: PBRC 2022-036
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Iron-deficiency; Iron Deficiency Anemia; Iron Deficiency Anemia Treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Profile of Mood States (POMS)

  Change from day 0 and day 56

• Appetite

  Change from day 0 and day 56

• Weight

  Change from day 0 and day 56

• Body composition

  Change from day 0 and day 56

• Blood pressure

  Change from day 0 and day 56

Study Arms (2)

Beef

EXPERIMENTAL

Other: Iron supplement with a lunch meal containing beef

Plant-based alternative

EXPERIMENTAL

Other: Iron supplement with a lunch meal containing plant-based alternative

Interventions

Iron supplement with a lunch meal containing beef OTHER

Participants will consume a lunch meal containing beef with an iron supplement for 8 weeks.

Beef

Iron supplement with a lunch meal containing plant-based alternative OTHER

Participants will consume a lunch meal containing plant-based alternative with an iron supplement for 8 weeks.

Plant-based alternative

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Assigned Female at birth; identify as a woman
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (1)

• Hennigar SR, Miller KM, Murphy RD, Braymer A, Mayet CL, Greenway FL, Cheung SN, Weschenfelder C, Berryman CE. Effects of consuming an iron supplement with a meal containing animal or plant-based meat on indicators of iron status and anemia in women of reproductive age with iron deficiency: a randomized, controlled study. Am J Clin Nutr. 2025 Sep;122(3):859-865. doi: 10.1016/j.ajcnut.2025.07.002. Epub 2025 Jul 7.

  PMID: 40633767 DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Iron-Dextran Complex

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 11, 2021
• Study Start: May 10, 2021
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)