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Meals to Improve Absorption of Iron Supplements

Primary Purpose

Iron-deficiency, Iron Deficiency Anemia, Iron Deficiency Anemia Treatment

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Iron supplement with a lunch meal containing beef
Iron supplement with a lunch meal containing plant-based alternative
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iron-deficiency

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Pennington Biomedical Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Beef

Plant-based alternative

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Appetite
Subjective appetite and satiety will be assessed before and after the lunch meal using visual analog scales.
Weight
Changes in body weight during the intervention will be compared between groups.
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.
Blood pressure
Changes in blood pressure during the intervention will be compared between groups.
Metabolic biomarkers
Changes in blood lipids, glucose, and insulin during the intervention will be compared between groups.
Plasma zinc
Changes in the plasma zinc during the intervention will be compared between groups.
Plasma vitamin B-12
Changes in the plasma vitamin B-12 during the intervention will be compared between groups.
Plasma choline
Changes in the plasma choline during the intervention will be compared between groups.

Full Information

First Posted
March 3, 2021
Last Updated
July 18, 2023
Sponsor
Pennington Biomedical Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT04793906
Brief Title
Meals to Improve Absorption of Iron Supplements
Official Title
Meals to Improve Absorption of Iron Supplements and Iron Status in Iron Deficient Women of Reproductive Age: a Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2021 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron-deficiency, Iron Deficiency Anemia, Iron Deficiency Anemia Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Beef
Arm Type
Experimental
Arm Title
Plant-based alternative
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Iron supplement with a lunch meal containing beef
Intervention Description
Participants will consume a lunch meal containing beef with an iron supplement for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Iron supplement with a lunch meal containing plant-based alternative
Intervention Description
Participants will consume a lunch meal containing plant-based alternative with an iron supplement for 8 weeks.
Primary Outcome Measure Information:
Title
Iron status
Description
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.
Time Frame
Change from day 0 and day 56
Secondary Outcome Measure Information:
Title
Profile of Mood States (POMS)
Description
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.
Time Frame
Change from day 0 and day 56
Title
Appetite
Description
Subjective appetite and satiety will be assessed before and after the lunch meal using visual analog scales.
Time Frame
Change from day 0 and day 56
Title
Weight
Description
Changes in body weight during the intervention will be compared between groups.
Time Frame
Change from day 0 and day 56
Title
Body composition
Description
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.
Time Frame
Change from day 0 and day 56
Title
Blood pressure
Description
Changes in blood pressure during the intervention will be compared between groups.
Time Frame
Change from day 0 and day 56
Title
Metabolic biomarkers
Description
Changes in blood lipids, glucose, and insulin during the intervention will be compared between groups.
Time Frame
Change from day 0 and day 56
Title
Plasma zinc
Description
Changes in the plasma zinc during the intervention will be compared between groups.
Time Frame
Change from day 0 and day 56
Title
Plasma vitamin B-12
Description
Changes in the plasma vitamin B-12 during the intervention will be compared between groups.
Time Frame
Change from day 0 and day 56
Title
Plasma choline
Description
Changes in the plasma choline during the intervention will be compared between groups.
Time Frame
Change from day 0 and day 56

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Assigned Female at birth; identify as a woman
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen Hennigar, PhD
Phone
225-763-2612
Email
stephen.hennigar@pbrc.edu
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Hennigar, PhD
Phone
225-763-2612
Email
stephen.hennigar@pbrc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Meals to Improve Absorption of Iron Supplements

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