- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05740462
Hydroponic Fortification and Dietary App Effect on Nutrients Level (Harvest)
Hydroponic Fortification and Dietary App Effect on Vitamin B12 and Iron (Fe) Status - The Harvest Study, A Randomised Double-blinded Study
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Norwich, United Kingdom, NR4 7UQ
- Quadram Institute Bioscience
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 <40 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].
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Dietary app 2
Dietary app recommends standard iron recipes
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Participants will eat two recipes a day for 17 weeks
Participants will grow vitamin B12 biofortified plants for 17 weeks and consume (10 grams) of plant material for 11 weeks.
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Experimental: Dietary app 1
Dietary app recommends high iron or iron-focused recipes
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Participants will eat two recipes a day for 17 weeks
Participants will grow vitamin B12 biofortified plants for 17 weeks and consume (10 grams) of plant material for 11 weeks.
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Experimental: Hydroponic unit 1
Growing vitamin B12 biofortified plants in a hydroponic unit and will be randomised to dietary app 1 or 2
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Participants will eat two recipes a day for 17 weeks
Participants will grow vitamin B12 biofortified plants for 17 weeks and consume (10 grams) of plant material for 11 weeks.
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No Intervention: Hydroponic unit 2
No hydroponic unit be given to participants and will be randomised to dietary app 1 or 2
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in serum ferritin after the dietary app intervention
Time Frame: Week: 0, 6/7 and 17
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Comparison of serum ferritin at baseline and after the intervention
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Week: 0, 6/7 and 17
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Change of serum B12 after the hydroponic unit intervention
Time Frame: Week: 6/7 and 17
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Comparison of serum B12 at baseline and after the intervention
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Week: 6/7 and 17
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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comparison of hsCRP at baseline and after dietary app intervention
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Week: 0 to 6/7, 6/7 to 17, and 0 to 17
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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
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comparison of FBC in venous blood sample at baseline and after dietary app intervention
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Week: 0 to 6/7, 6/7 to 17, and 0 to 17
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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
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comparison of sTfR in venous blood sample at baseline and after dietary app intervention
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Week: 0 to 6/7, 6/7 to 17, and 0 to 17
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Change in alpha 1 acid glycoprotein (AGP) with dietary app (high or standard iron) recipe intervention
Time Frame: Week: 0 and 17
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comparison of AGP in venous blood sample at baseline and after dietary app intervention
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Week: 0 and 17
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Change in holo-transcobalamin (Holo-TC) after the hydroponic unit (biofortification) intervention
Time Frame: Week: 0 and 17
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Measurement of holo-TC in venous blood sample at baseline and after the hydroponic unit intervention
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Week: 0 and 17
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Change in methylmalonic acid (MMA) after the hydroponic unit (biofortification) intervention
Time Frame: Week: 0 and 17
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Measurement of MMA in venous blood sample at baseline and after the hydroponic unit intervention
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Week: 0 and 17
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Change in total plasma homocysteine (tHcy) after the hydroponic unit (biofortification) intervention
Time Frame: Week: 0 and 17
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Measurement of tHcy in venous blood sample at baseline and after the hydroponic unit intervention
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Week: 0 and 17
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Paul A Kroon, PhD, Quadram Institute Bioscience
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- The Harvest Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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