Meals to Improve Absorption of Iron Supplements

Sponsor
Florida State University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04793906
Collaborator
(none)
80
1
2
23.7
3.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Iron supplement with a lunch meal containing beef
  • Other: Iron supplement with a lunch meal containing plant-based alternative
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Meals to Improve Absorption of Iron Supplements and Iron Status in Iron Deficient Women of Reproductive Age: a Randomized, Controlled Trial
Actual Study Start Date :
May 10, 2021
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Iron status [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 Outcome Measures

  1. Profile of Mood States (POMS) [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 [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 [Change from day 0 and day 56]

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

  4. Body composition [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 [Change from day 0 and day 56]

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

  6. Metabolic biomarkers [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 [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 [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 [Change from day 0 and day 56]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Florida State University Tallahassee Florida United States 32306

Sponsors and Collaborators

  • Florida State University

Investigators

  • Principal Investigator: Stephen Hennigar, Ph.D., Florida State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Stephen R. Hennigar, Ph.D., Assistant Professor, Florida State University
ClinicalTrials.gov Identifier:
NCT04793906
Other Study ID Numbers:
  • 2020.1182
First Posted:
Mar 11, 2021
Last Update Posted:
Nov 24, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 24, 2021