Meals to Improve Absorption of Iron Supplements

Iron Deficiency Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04793906
• Other study ID #: PBRC 2022-036
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2021
• Est. completion date: May 2024

Study information

• Verified date: July 2023
• Source: Pennington Biomedical Research Center
• Contact: Stephen Hennigar, PhD
• Phone: 225-763-2612
• Email: stephen.hennigar[@]pbrc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Iron Deficiency Anemia
• Iron Deficiency Anemia Treatment
• Iron-deficiency

Intervention

Other:
• Iron supplement with a lunch meal containing beef
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
Participants will consume a lunch meal containing plant-based alternative with an iron supplement for 8 weeks.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Change from day 0 and day 56
Secondary	Appetite	Subjective appetite and satiety will be assessed before and after the lunch meal using visual analog scales.	Change from day 0 and day 56
Secondary	Weight	Changes in body weight during the intervention will be compared between groups.	Change from day 0 and day 56
Secondary	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.	Change from day 0 and day 56
Secondary	Blood pressure	Changes in blood pressure during the intervention will be compared between groups.	Change from day 0 and day 56
Secondary	Metabolic biomarkers	Changes in blood lipids, glucose, and insulin during the intervention will be compared between groups.	Change from day 0 and day 56
Secondary	Plasma zinc	Changes in the plasma zinc during the intervention will be compared between groups.	Change from day 0 and day 56
Secondary	Plasma vitamin B-12	Changes in the plasma vitamin B-12 during the intervention will be compared between groups.	Change from day 0 and day 56
Secondary	Plasma choline	Changes in the plasma choline during the intervention will be compared between groups.	Change from day 0 and day 56