Does increasing lean red meat intake impact iron status in physically-active women?
| ISRCTN | ISRCTN43345245 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43345245 |
| Secondary identifying numbers | DCUREC2022_120 |
- Submission date
- 15/05/2023
- Registration date
- 16/05/2023
- Last edited
- 21/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
Female athletes and active adult females participating in high volumes of exercise are at increased risk of compromised iron status due to heightened iron losses through menstruation and exercise-induced mechanisms associated with exercise training. Oral iron supplementation is commonly used in the prevention or/and treatment of iron deficiency but has been criticised because of the side effects such as constipation and increased risk of iron toxicity associated with the use of supplements. The prescription of an iron-rich and/or heme-iron-based diet (from meat) can assist in improving and maintaining iron status in females, and this study is needed to explore this paradigm. Therefore, this project will investigate the effects of the consumption of lean red meat on iron status in iron deficient physically-active females in comparison to a habitual diet or an oral iron supplement.
Who can participate?
Physically-active females aged 18 to 40 who are defined as iron deficient without anaemia
What does the study involve?
Participants will be randomised into one of the three groups for the 12 week intervention: CON - habitual diet with the provision of oral placebo (gelatine capsules) to be consumed on alternate days for 12 weeks; SUPP - habitual diet with the provision of oral iron supplement to be consumed on alternate days for 12 weeks; MEAT - habitual diet with the provision of portions of lean red meat to be consumed for dinner on alternates days for 12 weeks.
What are the possible benefits and risks of participating?
Direct benefits will include each participant receiving information on her iron status, nutrient intakes, and measures of body composition. At the end of the study, each participant will receive a document that includes her results from all four visits, and accurate advice and information on all aspects of diet to do with improving iron status.
Where is the study run from?
Dublin City University (Ireland)
When is the study starting and how long is it expected to run for?
January 2022 to December 2024
Who is funding the study?
Enterprise Ireland
Who is the main contact?
Dr Brendan Egan, brendan.egan@dcu.ie
Contact information
Principal Investigator
School of Health and Human Performance
Glasnevin
D09 X7H5
Ireland
 ORCID ID |
0000-0001-8327-9016 |
|---|---|
| Phone | +353 1 700 8803 |
| brendan.egan@dcu.ie |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Fitness/sport facility, University/medical school/dental school |
| Study type | Quality of life, Treatment, Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Effects of increased consumption of lean red meat on iron status in iron-deficient physically-active females |
| Study acronym | RMIDNA |
| Study hypothesis | Regular intake of lean red meat can improve iron status in iron-deficient non-anaemic physically-active females |
| Ethics approval(s) | Approved 09/03/2023, Dublin City University Research Ethics Committee (DCU Glasnevin Campus, Invent Building, DCU, Glasnevin, Dublin 9; Republic of Ireland; +353 1 7008000; research@dcu.ie), ref: DCUREC/2022/120 |
| Condition | Iron deficiency without anemia |
| Intervention | 48 physically-active iron-deficient non-anaemic female participants (per trial arm: n=16; age 18 to 40 years, currently active for 4 exercise sessions per week lasting more than 30 minutes each at high intensity, or more 60 minutes at moderate intensity, or a combination thereof moderate and high-intensity sessions) will be randomly assigned to either a control group or a 12-week intervention of Control diet (their habitual diet), Supplement (provision of oral iron supplements), and Meat (provision of lean red meat). The participants will be pre-screened (Phase I) for their level of physical activity (IPAQ Questionnaire), and fatigue risk using an online Low Energy Availability in Females Questionnaire (LEAF) and subjective ratings of fatigue (POMS). Those identified at risk then moving forward to blood sample (in the follicular phase of their menstrual cycle on day 3 to day 5 of full flow) for analysis of the various markers of iron status (baseline serum blood sample) and habitual dietary iron intake using a 4-day portion estimate food diary. If fulfilling the inclusion criteria for iron status, participants will be matched for baseline iron status and habitual dietary iron intake before block randomisation into one of the three groups for the 12 week intervention (Phase II, starting on day 6 to 8 from the first day of full flow). •CON: habitual diet with the provision of oral placebo (gelatine capsules) to be consumed on alternate days for 12 weeks. •SUPP: habitual diet with the provision of oral iron supplement providing 325 mg ferrous sulfate (an additional 105 mg of elemental iron) to be consumed on alternate days for 12 weeks. •MEAT: habitual diet with the provision of portions of lean red meat (170 g uncooked = ~ 120 g serving of cooked beef in the form of lean mince (~5% fat), stewing beef, or steaks; ~3 to 5 mg additional iron) to be consumed for dinner (at or after 6 PM) on alternates days for 12 weeks. Participants will be assessed before (0 week), during (4 and 8 weeks) and after (12 weeks) the intervention period specifically for: Iron status from a venous blood sample; Body composition will be measured by bioelectrical spectroscopy (SOZO, Impedimed) and skinfold measurement by callipers; Subjective ratings of fatigue and mood states (POMS); Dietary habits will be assessed by a 4 day portion estimate food diary with analysis by commercial dietary analysis software (Nutritics). The discordance between the daily iron intakes of SUPP and MEAT is intentional and acknowledged but represents a pragmatic approach. SUPP reflects recent sports nutrition guidelines for iron supplementation in female athletes and MEAT reflects the approximate intake from a previous study of meat and iron status in exercising females as well as an average portion described by The Health Service Executive (HSE) of Ireland Food Guidelines. |
| Intervention type | Mixed |
| Primary outcome measure | Iron status: serum iron, serum transferrin receptor, transferrin, transferrin saturation, and ferritin measures from which total iron binding capacity and serum transferrin receptor/log ferritin ratio will be calculated from a venous blood sample at baseline, 4, 8 and after 12 weeks. |
| Secondary outcome measures | 1. Subjective ratings of fatigue: Measured using an online Low Energy Availability in Females Questionnaire (LEAF) and subjective ratings of fatigue and mood state (Profile of Mood States- POMS Questionnaire) at 0, 4, 8 and after 12 weeks; 2. Body composition by bioelectrical spectroscopy (SOZO, Impedimed) and skinfold measurement by callipers at 0, 4, 8 and after 12 weeks; 3. Dietary iron intake will be assessed by a 4-day food diary with analysis by commercial dietary analysis software (Nutritics) at 0, 4, 8 and after 12 weeks; 4. Full blood count including hemoglobin measured in blood samples at 0, 4, 8 and after 12 weeks; 5. Types of the intensity of physical activity and sitting time that people do as part of their daily lives to estimate the total physical activity in MET-min/week and time spent sitting, the International Physical Activity Questionnaire (IPAQ), at 0, 4, 8 and after 12 weeks. 6. Training log recording session duration and session RPE throughout the 12 week period. |
| Overall study start date | 03/01/2022 |
| Overall study end date | 31/12/2024 |
Eligibility
| Participant type(s) | Healthy volunteer, Other |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 40 Years |
| Sex | Female |
| Target number of participants | 48 |
| Total final enrolment | 40 |
| Participant inclusion criteria | Phase I 1. Female; 2. Aged 18 to 40 years; 3. Physically active defined as currently active for not less than 4 exercise sessions per week lasting more than 30 minutes each at high intensity, or more than 60 minutes at moderate intensity, or a combination thereof moderate and high intensity sessions; Phase II 4. Participants fulfilling the inclusion criteria for status as iron deficient without anaemia i.e. a haemoglobin concentration not less than 12.0 g/dL i.e. non-anaemic, and either serum ferritin = or more than 12 and <35μg/L, or transferrin saturation <16%, or both, combined with habitual dietary iron intake of less than the current estimated average requirement (EAR) i.e. <11.4 mg/day, will be eligible to move forward into Phase II. |
| Participant exclusion criteria | 1. Male; 2. Individuals under the age of 18 and over 40 years of age; 3. Individuals with normal iron status (Ferritin >35 μg/L and haemoglobin = or more than 12 g/dL); Individuals with anaemia (haemoglobin <12 g/dL for females); 4. Individuals who present with neuromuscular, chronic, and metabolic diseases and carriers of high-risk blood-borne diseases; 5. Individuals currently on an energy-restricted diet; 6. Individuals currently supplementing with iron or vitamin C supplements; 7. Individuals currently practising a dietary restriction as vegetarian, vegan, ketogenic or Low carbohydrate diet (defined as CHO intake of <130 g/day); 8. Habitual dietary iron intake in accordance to the current estimated average requirement (EAR) i.e. = or more than 11.4 mg/day |
| Recruitment start date | 01/06/2023 |
| Recruitment end date | 31/01/2024 |
Locations
Countries of recruitment
- Ireland
Study participating centre
Glasnevin
D09 X7H5
Ireland
Sponsor information
University/education
School of Health & Human Performance
Glasnevin
Dublin 9
Ireland
| Phone | +353 17008803 |
|---|---|
| rec@dcu.ie | |
| Website | http://www.dcu.ie/ |
"ROR" |
https://ror.org/04a1a1e81 |
Funders
Funder type
Government
Government organisation / National government
- Location
- Ireland
Results and Publications
| Intention to publish date | 31/03/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Results may be disseminated in academic journal publications and presented at scientific conferences, but never as an individual’s identifiable data. At major intervals (e.g when a phase of the project is finished, or a paper is published), participants will be informed via email. Emails will include a lay description of what findings were published and the research team’s interpretation of these findings. Participants may contact the research team should they have interest in the progress of the project, and will be given access to publication manuscripts or research posters/slides upon request. Feedback on the outcome of the pre-screening process (assessment of iron status) will be provided to each individual participant for their own data, as will feedback on the outcomes of the study itself for each individual participant for their own data. |
| IPD sharing plan | The data sets generated during and/or analysed during the current study will be available on request from brendan.egan@dcu.ie |
Editorial Notes
21/10/2024: The following changes were made:
1. The overall end date was changed from 31/10/2024 to 31/12/2024.
2. The intention to publish date was changed from 31/01/2025 to 31/03/2025.
3. The total final enrolment number.
20/05/2024: The following changes were made:
1. The overall end date was changed from 07/05/2024 to 31/10/2024.
2. The intention to publish date was changed from 30/09/2024 to 31/01/2025.
3. The plain English summary was updated to reflect these changes.
23/10/2023: The following changes were made:
1. The recruitment end date was changed from 30/09/2023 to 31/01/2024.
2. The overall end date was changed from 31/12/2023 to 07/05/2024.
3. The intention to publish date was changed from 01/03/2024 to 30/09/2024.
4. The plain English summary was updated to reflect these changes.
16/05/2023: Trial's existence confirmed by Dublin City University
