HealthyNCT05392816
Non-heme Iron Absorption From Single Meals of Fava Bean Protein, Beef Protein and Cod Protein
A study testing Single meal non-heme iron absorption in people with Healthy and Nutrition, Healthy, run by Chalmers University of Technology at 1 site in Sweden.
Trial summary
The aim of this study is to investigate the non-heme iron absorption from single meals of texturized fava bean protein, which has been suggested as a protein source suitable for replacement of meat, compared to the non-heme iron absorption from beef protein and cod protein meals. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Nutrition, Healthy
- What is being tested?
- Single meal non-heme iron absorption
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 6 Sep 2021to 2 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- Age 18-45
- Is tolerant to intake of fava bean
- Eats fish and meat
- Feels healthy
- Can eat a breakfast consisting of three potato-based patties
Who cannot join
- Other sex than female
- Age <18 and >45
- Has an ongoing infection
- Is vegetarian
- Is pregnant or lactating
- Takes iron supplements
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Chalmers University of Technology, Division of Food Science
Gothenburg, 41296
About this study
Official title: Non-heme Iron Absorption From Single Meals of Fava Bean Protein, Beef Protein and Cod Protein in Healthy Females in Fertile Ages
The aim of this study is to investigate the non-heme iron absorption from single meals of texturized fava bean protein, which has been suggested as a protein source suitable for replacement of meat, compared to the non-heme iron absorption from beef protein and cod protein meals. The study participants are women of fertile ages, which is one of the main groups at risk of developing iron deficiency. Since a dietary shift towards increasingly plant based is being pushed, investigating nutritional effects of such a shift is essential to avoid potential negative effects such as an increase of nutritional deficiencies. The study includes two cross-over single-blinded iron isotope trials in apparent healthy Swedish women of the ages 18-45 years, each of whom served as their own control. Participants will be served matched test meals containing beef and fava bean protein (Study 1), or cod and fava bean protein (Study 2) with radiolabeled non-heme iron 55Fe and 59Fe. Absorption of non-heme iron from test meals will be measured by whole-body counting, and erythrocyte incorporation by liquid scintillation.
- Conditions
- Healthy, Nutrition, Healthy
- Being tested
- Single meal non-heme iron absorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single meal non-heme iron absorptionOther
Two study groups, each designed as cross-over single-blinded iron isotope trials in apparent healthy Swedish women of the ages 18-45 years. Each participant serves as their own control. Meals are tagged with radiolabeled non-heme iron 55Fe and 59Fe.
| Study group | Role | What they receive |
|---|---|---|
| Study group 1. Texturized fava protein meal and beef protein meal | Other | Participants recruited to study group 1 will be served a meal with fava bean protein (B) and beef protein (A), each meal twice which in total brings four meals on four consecutive days as fasting breakfast. Meals are served in the order BBAA Receives: Other: Single meal non-heme iron absorption |
| Study group 2. Texturized fava protein meal and cod protein meal | Other | Participants recruited to study group 1 will be served a meal with fava bean protein (B) and cod protein (A), each meal twice which in total brings four meals on four consecutive days as fasting breakfast. Meals are served in the order BBAA Receives: Other: Single meal non-heme iron absorption |
What is being measured
The primary outcome is the main question the study is designed to answer.
59Fe non-heme iron absorption from cod and beef protein meals
Absorption of 59Fe, which is added to the animal protein meals, will be measured by a whole body counter which enables measurement of absolute value.
Measured: 5 weeks
55Fe non-heme iron absorption from fava bean protein meals.
The absorption quota of 59Fe/55Fe is measured by erythrocyte incorporation, analyzed by liquid scintillation. The absorbance quota, in combination with the absolute value of the whole body counter, will be used to calculate the absorbance of 55Fe which is added to the fava bean meals
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start6 Sep 2021
- Primary completion2 Jun 2022
- Study completion2 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chalmers University of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Göteborg University
- Responsible party
- Principal investigator, Rikard Landberg, Chalmers University of Technology
- Investigators
- Ann-Sofie Sandberg, Professor, Principal investigator, Chalmers University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392816
- Sponsor's protocol ID
- 573-18
- Status last verified
- Jun 2022
- First submitted
- 17 May 2022
- Last updated
- 3 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-heme Iron Absorption From Single Meals of Fava Bean Protein, Beef Protein and Cod Protein in Healthy Females in Fertile Ages
- ClinicalTrials.gov ID
- NCT05392816
- Acronym / sponsor ID
- 573-18
- Conditions
- Healthy, Nutrition, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chalmers University of TechnologyUniversity, hospital or other
- Collaborators
- Göteborg University
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 2 Jun 2022 (actual)
- Study completion
- 2 Jun 2022 (actual)
- First posted
- 26 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the non-heme iron absorption from single meals of texturized fava bean protein, which has been suggested as a protein source suitable for replacement of meat, compared to the non-heme iron absorption from beef protein and cod protein meals. The study participants are women of fertile ages, which is one of the main groups at risk of developing iron deficiency. Since a dietary shift towards increasingly plant based is being pushed, investigating nutritional effects of such a shift is essential to avoid potential negative effects such as an increase of nutritional deficiencies. The study includes two cross-over single-blinded iron isotope trials in apparent healthy Swedish women of the ages 18-45 years, each of whom served as their own control. Participants will be served matched test meals containing beef and fava bean protein (Study 1), or cod and fava bean protein (Study 2) with radiolabeled non-heme iron 55Fe and 59Fe. Absorption of non-heme iron from test meals will be measured by whole-body counting, and erythrocyte incorporation by liquid scintillation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group 1. Texturized fava protein meal and beef protein meal | Other | Other: Single meal non-heme iron absorptionParticipants recruited to study group 1 will be served a meal with fava bean protein (B) and beef protein (A), each meal twice which in total brings four meals on four consecutive days as fasting breakfast. Meals are served in the order BBAA |
| Study group 2. Texturized fava protein meal and cod protein meal | Other | Other: Single meal non-heme iron absorptionParticipants recruited to study group 1 will be served a meal with fava bean protein (B) and cod protein (A), each meal twice which in total brings four meals on four consecutive days as fasting breakfast. Meals are served in the order BBAA |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female
- Age 18-45
- Is tolerant to intake of fava bean
- Eats fish and meat
- Feels healthy
Key exclusion criteria (6 listed)
- Other sex than female
- Age <18 and >45
- Has an ongoing infection
- Is vegetarian
- Is pregnant or lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single meal non-heme iron absorptionTwo study groups, each designed as cross-over single-blinded iron isotope trials in apparent healthy Swedish women of the ages 18-45 years. Each participant serves as their own control. Meals are tagged with radiolabeled non-heme iron 55Fe and 59Fe. | Other | Study group 1. Texturized fava protein meal and beef protein meal, Study group 2. Texturized fava protein meal and cod protein meal |
Primary outcome
59Fe non-heme iron absorption from cod and beef protein meals
Time frame: 5 weeks
Absorption of 59Fe, which is added to the animal protein meals, will be measured by a whole body counter which enables measurement of absolute value.
55Fe non-heme iron absorption from fava bean protein meals.
Time frame: 5 weeks
The absorption quota of 59Fe/55Fe is measured by erythrocyte incorporation, analyzed by liquid scintillation. The absorbance quota, in combination with the absolute value of the whole body counter, will be used to calculate the absorbance of 55Fe which is added to the fava bean meals
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann-Sofie Sandberg, Professor principal investigator
Chalmers University of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single meal non-heme iron absorption in people with Healthy and Nutrition, Healthy, run by Chalmers University of Technology at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
59Fe non-heme iron absorption from cod and beef protein meals (time frame: 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022.