Meals to Improve Absorption of Iron Supplements

Last updated: February 5, 2025
Sponsor: Pennington Biomedical Research Center
Overall Status: Completed

Phase

N/A

Condition

Anemia

Treatment

Iron supplement with a lunch meal containing plant-based alternative

Iron supplement with a lunch meal containing beef

Clinical Study ID

NCT04793906
PBRC 2022-036
  • Ages 18-40
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Body mass index (BMI) falls within the normal weight or overweight range (18.5-29.9kg/m^2)

  • Low iron stores (serum ferritin <25 μg/L)

  • Willing to refrain from smoking and >2 alcoholic drinks/week for the duration of thestudy period

  • Willing to refrain from vitamin and mineral supplementation for the duration of thestudy

Exclusion

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 ofthe 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, butnot limited to, diverticulosis, diverticulitis and inflammatory bowel disease,peptic ulcer disease, Crohn's disease, ulcerative colitis; or previousgastrointestinal surgery

  • Blood donation within 4 months of beginning the study

  • Abnormal blood clotting

Study Design

Total Participants: 59
Treatment Group(s): 2
Primary Treatment: Iron supplement with a lunch meal containing plant-based alternative
Phase:
Study Start date:
May 10, 2021
Estimated Completion Date:
November 01, 2024

Connect with a study center

  • Florida State University

    Tallahassee, Florida 32306
    United States

    Site Not Available

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana 70808
    United States

    Site Not Available

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