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NCT Number: NCT04793906

Meals to Improve Absorption of Iron Supplements

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.

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Key information

Conditions

Iron-deficiency Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Deficiency Anemia Iron Deficiency Anemia Treatment Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iron supplement with a lunch meal containing beef

Other

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

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.

Primary outcomes

  1. Iron status

    Time frame: Change from day 0 and day 56

    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.

Secondary outcomes

  1. Profile of Mood States (POMS)

    Time frame: Change from day 0 and day 56

    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.

  2. Appetite

    Time frame: Change from day 0 and day 56

    Subjective appetite and satiety will be assessed before and after the lunch meal using visual analog scales.

  3. Weight

    Time frame: Change from day 0 and day 56

    Changes in body weight during the intervention will be compared between groups.

  4. Body composition

    Time frame: Change from day 0 and day 56

    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.

  5. Blood pressure

    Time frame: Change from day 0 and day 56

    Changes in blood pressure during the intervention will be compared between groups.

  6. Metabolic biomarkers

    Time frame: Change from day 0 and day 56

    Changes in blood lipids, glucose, and insulin during the intervention will be compared between groups.

  7. Plasma zinc

    Time frame: Change from day 0 and day 56

    Changes in the plasma zinc during the intervention will be compared between groups.

  8. Plasma vitamin B-12

    Time frame: Change from day 0 and day 56

    Changes in the plasma vitamin B-12 during the intervention will be compared between groups.

  9. Plasma choline

    Time frame: Change from day 0 and day 56

    Changes in the plasma choline during the intervention will be compared between groups.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 11, 2021
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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