Iron Deficiency (Without Anemia)NCT05740462
Hydroponic Fortification and Dietary App Effect on Nutrients Level (Harvest)
A study testing Recipes consumption and Hydroponic unit in people with Iron Deficiency (Without Anemia) and B12 Deficiency Vitamin, run by Quadram Institute Bioscience at 1 site in United Kingdom.
Trial summary
Veganism and vegetarianism have clear benefits where they have a lower risk of many health issues. However, they also have a higher risk of nutrients and vitamin deficiency such as iron and vitamin B12. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency (Without Anemia), B12 Deficiency Vitamin
- What is being tested?
- Recipes consumption and Hydroponic unit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 May 2023to 1 Sep 2025
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women over 18 years with a regular menstruation cycle (>21 and <40 days).
- Has followed a vegan or vegetarian diet that does not include the consumption of meat or fish for at least 1 year.
- Willing to remain on their background diet for the duration of the study.
- Those who are on a routine regimen of iron and/or vitamin B12 supplements must maintain the same doses 3 month prior to the study and during the duration of the study.
- Non-anaemic, haemoglobin (Hb) concentration ≥120 g/L.
- SF >15 µg/L and <60 µg/L [WHO uses the following cut-offs for context: below 15 µg/L indicates iron deficiency, 16-40 µg/L indicates borderline deficiency, and 41 - 150 µg/L is normal].
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- Body Mass Index (BMI) between 18.5 - 40 kg/m2.
- Live within 40 miles of the Norwich Research Park.
- Willing to consume plants grown in the hydroponic unit (e.g., spinach, rocket, mizuna) if they agreed to have a unit.
- Access to a smartphone or online platform a well as access to the internet.
Who cannot join
- Those who have known allergies to the hydroponically grown salad greens (spinach, rocket, mizuna).
- Flexitarian (consumes meat intermittently) vegetarian.
- Those with menstruation cycle time periods of <21 or >40-days
- BMI at screening visit < 18.5 kg/m2 (underweight) and > 40 kg/m2 (severely obese).
- Those diagnosed with or undergoing treatment for anaemia.
- Currently pregnant, lactating or trying to conceive.
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- High alcohol consumption, consuming more than 2 drinks per day, can elevate the risk for iron overload.
- Current smoker or has only ceased in the last 6 months.
- Diagnosed medical conditions that may impact the study outcomes will be considered on an individual basis.
- Those with an eating disorders, which may impact the study outcome.
- On, or about to start, a diet programme such as the 5:2 programme (5:2 programme is where an individual would eat normally for five days a week, and fast for two days a week by reducing calorie consumption).
- Unable to give written or verbal informed consent.
- Individuals who cannot understand the written instructions/questionnaires.
- Unwilling to give GP contact details.
- Participating in another dietary intervention study or has given blood in another research study during the last 3 months.
- Any person related to or living with any member of the study team.
- Those who are part of the Line Manager/supervisory structure of the Chief Investigator.
- Those who have been asked to self-isolate or have been diagnosed with COVID-19 in the last 14 days. However, participants can be rescreened 7 days after the isolation period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hydroponic Fortification and Dietary App Effect on Vitamin B12 and Iron (Fe) Status - The Harvest Study, A Randomised Double-blinded Study
Veganism and vegetarianism have clear benefits where they have a lower risk of many health issues. However, they also have a higher risk of nutrients and vitamin deficiency such as iron and vitamin B12. Iron can be found in plant-based food but in varying quantities, whereas vitamin B12 is mainly found in red meat, thus vegans and vegetarians can only take this vitamin in supplements such as tablets. In this study, the investigators are testing two interventions, the consumption of recipes with a certain iron amount to increase iron levels, and the consumption of vitamin B12 biofortified plants to increase serum B12 levels in vegan and vegetarian participants.
Read the detailed description
Iron is present in plant and animal-derived foods but the fractional absorption of iron from plant foods (that is the percent of iron absorbed from a consumed quantity) is often low (approx 10%) compared to iron from animal sources 25%-30%. It is therefore more challenging for vegans and vegetarians to achieve the Reference Nutrient Intake (RNI) for iron (8.7 mg/day for men over 18 and women over 50, 14.8 mg/day for women aged 18-50), and they are likely to absorb less of that iron and therefore are more likely to become iron depleted.
Plants do not synthesise vitamin B12 and unless fortified, plant-derived foods and beverages do not contain any vitamin B12. the RNI for vitamin B12 in the UK is 1.5 µg/day, therefore it is crucial that vegans and vegetarians take B12 supplements if they don't consume B12-fortified foods or find other ways of incorporating this vitamin into their diets.
The HARVEST study is a 17-week randomised, controlled, double-blinded, parallel dietary intervention study conducted at the Quadram Institute Clinical Research Facility (QI CRF), Norwich, UK. Investigators are seeking vegan or vegetarian women (18 to 50 years old) to test two interventions, iron-specific recipes and B12 biofortified plants grown in a kitchen garden. There are a total of 4 visits (1 screening visit, 2 2-hours visits and 1 short visit). Investigators will assess blood samples for serum ferritin, serum B12 and other iron and B12 biomarkers. Investigators will ask the participant to complete lifestyle questionnaires regarding their dietary pattern, fatigue level and satisfaction and impression of the study tools.
- Being tested
- Recipes consumption, Hydroponic unit
- Keywords
- Hydroponic, Dietary app, Salad greens, Iron ferritin, Vitamin B12, vegan recipes
- Medical subject headings
- Iron Deficiencies, Vitamin B 12 Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recipes consumptionBehavioural
Participants will eat two recipes a day for 17 weeks
Hydroponic unitBehavioural
Participants will grow vitamin B12 biofortified plants for 17 weeks and consume (10 grams) of plant material for 11 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dietary app 1 | Experimental | Dietary app recommends high iron or iron-focused recipes Receives: Behavioral: Recipes consumption; Behavioral: Hydroponic unit |
| Dietary app 2 | Sham comparator | Dietary app recommends standard iron recipes Receives: Behavioral: Recipes consumption; Behavioral: Hydroponic unit |
| Hydroponic unit 1 | Experimental | Growing vitamin B12 biofortified plants in a hydroponic unit and will be randomised to dietary app 1 or 2 Receives: Behavioral: Recipes consumption; Behavioral: Hydroponic unit |
| Hydroponic unit 2 | No intervention | No hydroponic unit be given to participants and will be randomised to dietary app 1 or 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum ferritin after the dietary app intervention
Comparison of serum ferritin at baseline and after the intervention
Measured: Week: 0, 6/7 and 17
Change of serum B12 after the hydroponic unit intervention
Comparison of serum B12 at baseline and after the intervention
Measured: Week: 6/7 and 17
Secondary outcomes (7)
Change in high sensitivity C-reactive protein (hsCRP) with dietary app (high or standard iron) recipe intervention
comparison of hsCRP at baseline and after dietary app intervention
Measured: Week: 0 to 6/7, 6/7 to 17, and 0 to 17
Change in full blood count (FBC) with dietary app (high or standard iron) recipe intervention
comparison of FBC in venous blood sample at baseline and after dietary app intervention
Measured: Week: 0 to 6/7, 6/7 to 17, and 0 to 17
Change in soluble transferrin receptor (sTfR) with dietary app (high or standard iron) recipe intervention
comparison of sTfR in venous blood sample at baseline and after dietary app intervention
Measured: Week: 0 to 6/7, 6/7 to 17, and 0 to 17
Change in alpha 1 acid glycoprotein (AGP) with dietary app (high or standard iron) recipe intervention
comparison of AGP in venous blood sample at baseline and after dietary app intervention
Measured: Week: 0 and 17
Change in holo-transcobalamin (Holo-TC) after the hydroponic unit (biofortification) intervention
Measurement of holo-TC in venous blood sample at baseline and after the hydroponic unit intervention
Measured: Week: 0 and 17
Change in methylmalonic acid (MMA) after the hydroponic unit (biofortification) intervention
Measurement of MMA in venous blood sample at baseline and after the hydroponic unit intervention
Measured: Week: 0 and 17
Change in total plasma homocysteine (tHcy) after the hydroponic unit (biofortification) intervention
Measurement of tHcy in venous blood sample at baseline and after the hydroponic unit intervention
Measured: Week: 0 and 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start4 May 2023
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency (Without Anemia)Studies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Quadram Institute Bioscience
- Sponsor type
- University, hospital or other
- Collaborators
- Norfolk and Norwich University Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Paul A Kroon, PhD, Principal investigator, Quadram Institute Bioscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05740462
- Sponsor's protocol ID
- The Harvest Study
- Status last verified
- Jul 2024
- First submitted
- 13 Feb 2023
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydroponic Fortification and Dietary App Effect on Vitamin B12 and Iron (Fe) Status - The Harvest Study, A Randomised Double-blinded Study
- ClinicalTrials.gov ID
- NCT05740462
- Acronym / sponsor ID
- The Harvest Study
- Keywords
- Hydroponic, Dietary app, Salad greens, Iron ferritin, Vitamin B12, vegan recipes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Quadram Institute BioscienceUniversity, hospital or other
- Collaborators
- Norfolk and Norwich University Hospitals NHS Foundation Trust
- Study start
- 4 May 2023 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 23 Feb 2023 (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.
Veganism and vegetarianism have clear benefits where they have a lower risk of many health issues. However, they also have a higher risk of nutrients and vitamin deficiency such as iron and vitamin B12. Iron can be found in plant-based food but in varying quantities, whereas vitamin B12 is mainly found in red meat, thus vegans and vegetarians can only take this vitamin in supplements such as tablets. In this study, the investigators are testing two interventions, the consumption of recipes with a certain iron amount to increase iron levels, and the consumption of vitamin B12 biofortified plants to increase serum B12 levels in vegan and vegetarian participants.
Detailed description
Iron is present in plant and animal-derived foods but the fractional absorption of iron from plant foods (that is the percent of iron absorbed from a consumed quantity) is often low (approx 10%) compared to iron from animal sources 25%-30%. It is therefore more challenging for vegans and vegetarians to achieve the Reference Nutrient Intake (RNI) for iron (8.7 mg/day for men over 18 and women over 50, 14.8 mg/day for women aged 18-50), and they are likely to absorb less of that iron and therefore are more likely to become iron depleted.
Plants do not synthesise vitamin B12 and unless fortified, plant-derived foods and beverages do not contain any vitamin B12. the RNI for vitamin B12 in the UK is 1.5 µg/day, therefore it is crucial that vegans and vegetarians take B12 supplements if they don't consume B12-fortified foods or find other ways of incorporating this vitamin into their diets.
The HARVEST study is a 17-week randomised, controlled, double-blinded, parallel dietary intervention study conducted at the Quadram Institute Clinical Research Facility (QI CRF), Norwich, UK. Investigators are seeking vegan or vegetarian women (18 to 50 years old) to test two interventions, iron-specific recipes and B12 biofortified plants grown in a kitchen garden. There are a total of 4 visits (1 screening visit, 2 2-hours visits and 1 short visit). Investigators will assess blood samples for serum ferritin, serum B12 and other iron and B12 biomarkers. Investigators will ask the participant to complete lifestyle questionnaires regarding their dietary pattern, fatigue level and satisfaction and impression of the study tools.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dietary app 1 | Experimental | Behavioral: Recipes consumption, Behavioral: Hydroponic unitDietary app recommends high iron or iron-focused recipes |
| Dietary app 2 | Sham comparator | Behavioral: Recipes consumption, Behavioral: Hydroponic unitDietary app recommends standard iron recipes |
| Hydroponic unit 1 | Experimental | Behavioral: Recipes consumption, Behavioral: Hydroponic unitGrowing vitamin B12 biofortified plants in a hydroponic unit and will be randomised to dietary app 1 or 2 |
| Hydroponic unit 2 | No intervention | –No hydroponic unit be given to participants and will be randomised to dietary app 1 or 2 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Women over 18 years with a regular menstruation cycle (>21 and <40 days).
- Has followed a vegan or vegetarian diet that does not include the consumption of meat or fish for at least 1 year.
- Willing to remain on their background diet for the duration of the study.
- Those who are on a routine regimen of iron and/or vitamin B12 supplements must maintain the same doses 3 month prior to the study and during the duration of the study.
- Non-anaemic, haemoglobin (Hb) concentration ≥120 g/L.
Key exclusion criteria (18 listed)
- Those who have known allergies to the hydroponically grown salad greens (spinach, rocket, mizuna).
- Flexitarian (consumes meat intermittently) vegetarian.
- Those with menstruation cycle time periods of <21 or >40-days
- BMI at screening visit < 18.5 kg/m2 (underweight) and > 40 kg/m2 (severely obese).
- Those diagnosed with or undergoing treatment for anaemia.
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 |
|---|---|---|
| Recipes consumptionParticipants will eat two recipes a day for 17 weeks | Behavioural | Dietary app 1, Dietary app 2, Hydroponic unit 1 |
| Hydroponic unitParticipants will grow vitamin B12 biofortified plants for 17 weeks and consume (10 grams) of plant material for 11 weeks. | Behavioural | Dietary app 1, Dietary app 2, Hydroponic unit 1 |
Primary outcome
Change in serum ferritin after the dietary app intervention
Time frame: Week: 0, 6/7 and 17
Comparison of serum ferritin at baseline and after the intervention
Change of serum B12 after the hydroponic unit intervention
Time frame: Week: 6/7 and 17
Comparison of serum B12 at baseline and after the intervention
7 secondary outcomes
Change in high sensitivity C-reactive protein (hsCRP) with dietary app (high or standard iron) recipe intervention
Time frame: Week: 0 to 6/7, 6/7 to 17, and 0 to 17
Change in full blood count (FBC) with dietary app (high or standard iron) recipe intervention
Time frame: Week: 0 to 6/7, 6/7 to 17, and 0 to 17
Change in soluble transferrin receptor (sTfR) with dietary app (high or standard iron) recipe intervention
Time frame: Week: 0 to 6/7, 6/7 to 17, and 0 to 17
Change in alpha 1 acid glycoprotein (AGP) with dietary app (high or standard iron) recipe intervention
Time frame: Week: 0 and 17
Change in holo-transcobalamin (Holo-TC) after the hydroponic unit (biofortification) intervention
Time frame: Week: 0 and 17
Change in methylmalonic acid (MMA) after the hydroponic unit (biofortification) intervention
Time frame: Week: 0 and 17
Change in total plasma homocysteine (tHcy) after the hydroponic unit (biofortification) intervention
Time frame: Week: 0 and 17
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Paul A Kroon, PhD principal investigator
Quadram Institute Bioscience
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recipes consumption and Hydroponic unit in people with Iron Deficiency (Without Anemia) and B12 Deficiency Vitamin, run by Quadram Institute Bioscience at 1 site in United Kingdom.
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 10 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 26 Jul 2024. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Change in serum ferritin after the dietary app intervention (time frame: Week: 0, 6/7 and 17). 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 26 Jul 2024.