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Hydroponic Fortification and Dietary App Effect on Nutrients Level (Harvest)

Primary Purpose

Iron Deficiency (Without Anemia), B12 Deficiency Vitamin

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Recipes consumption
Hydroponic unit
Sponsored by
Quadram Institute Bioscience
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Iron Deficiency (Without Anemia) focused on measuring Hydroponic, Dietary app, Salad greens, Iron ferritin, Vitamin B12, vegan recipes

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Quadram Institute Bioscience

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Experimental

No Intervention

Arm Label

Dietary app 1

Dietary app 2

Hydroponic unit 1

Hydroponic unit 2

Arm Description

Dietary app recommends high iron or iron focused recipes

Dietary app recommends standard iron recipes

Growing vitamin B12 biofortified plants in a hydroponic unit

No hydroponic unit given to participants

Outcomes

Primary Outcome Measures

Change in serum ferritin after the dietary app intervention
Comparison of serum ferritin at baseline and after the intervention
Change of serum B12 after the hydroponic unit intervention
Comparison of serum B12 at baseline and after the intervention

Secondary Outcome Measures

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
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
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
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
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
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
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

Full Information

First Posted
February 13, 2023
Last Updated
February 27, 2023
Sponsor
Quadram Institute Bioscience
Collaborators
Norfolk and Norwich University Hospitals NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05740462
Brief Title
Hydroponic Fortification and Dietary App Effect on Nutrients Level (Harvest)
Official Title
Hydroponic Fortification and Dietary App Effect on Vitamin B12 and Iron (Fe) Status - The Harvest Study, A Randomised Double-blinded Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 15, 2023 (Anticipated)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Quadram Institute Bioscience
Collaborators
Norfolk and Norwich University Hospitals NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency (Without Anemia), B12 Deficiency Vitamin
Keywords
Hydroponic, Dietary app, Salad greens, Iron ferritin, Vitamin B12, vegan recipes

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dietary app 1
Arm Type
Experimental
Arm Description
Dietary app recommends high iron or iron focused recipes
Arm Title
Dietary app 2
Arm Type
Sham Comparator
Arm Description
Dietary app recommends standard iron recipes
Arm Title
Hydroponic unit 1
Arm Type
Experimental
Arm Description
Growing vitamin B12 biofortified plants in a hydroponic unit
Arm Title
Hydroponic unit 2
Arm Type
No Intervention
Arm Description
No hydroponic unit given to participants
Intervention Type
Behavioral
Intervention Name(s)
Recipes consumption
Intervention Description
Participants will eat two recipes a day for 17 weeks
Intervention Type
Behavioral
Intervention Name(s)
Hydroponic unit
Intervention Description
Participants will grow vitamin B12 biofortified plants for 17 weeks and consume (10 grams) of plant material for 11 weeks.
Primary Outcome Measure Information:
Title
Change in serum ferritin after the dietary app intervention
Description
Comparison of serum ferritin at baseline and after the intervention
Time Frame
Week: 0, 6/7 and 17
Title
Change of serum B12 after the hydroponic unit intervention
Description
Comparison of serum B12 at baseline and after the intervention
Time Frame
Week: 6/7 and 17
Secondary Outcome Measure Information:
Title
Change in high sensitivity C-reactive protein (hsCRP) with dietary app (high or standard iron) recipe intervention
Description
comparison of hsCRP at baseline and after dietary app intervention
Time Frame
Week: 0 to 6/7, 6/7 to 17, and 0 to 17
Title
Change in full blood count (FBC) with dietary app (high or standard iron) recipe intervention
Description
comparison of FBC in venous blood sample at baseline and after dietary app intervention
Time Frame
Week: 0 to 6/7, 6/7 to 17, and 0 to 17
Title
Change in soluble transferrin receptor (sTfR) with dietary app (high or standard iron) recipe intervention
Description
comparison of sTfR in venous blood sample at baseline and after dietary app intervention
Time Frame
Week: 0 to 6/7, 6/7 to 17, and 0 to 17
Title
Change in alpha 1 acid glycoprotein (AGP) with dietary app (high or standard iron) recipe intervention
Description
comparison of AGP in venous blood sample at baseline and after dietary app intervention
Time Frame
Week: 0 and 17
Title
Change in holo-transcobalamin (Holo-TC) after the hydroponic unit (biofortification) intervention
Description
Measurement of holo-TC in venous blood sample at baseline and after the hydroponic unit intervention
Time Frame
Week: 0 and 17
Title
Change in methylmalonic acid (MMA) after the hydroponic unit (biofortification) intervention
Description
Measurement of MMA in venous blood sample at baseline and after the hydroponic unit intervention
Time Frame
Week: 0 and 17
Title
Change in total plasma homocysteine (tHcy) after the hydroponic unit (biofortification) intervention
Description
Measurement of tHcy in venous blood sample at baseline and after the hydroponic unit intervention
Time Frame
Week: 0 and 17

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul A Kroon, PhD
Organizational Affiliation
Quadram Institute Bioscience
Official's Role
Principal Investigator
Facility Information:
Facility Name
Quadram Institute Bioscience
City
Norwich
ZIP/Postal Code
NR4 7UQ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Hydroponic Fortification and Dietary App Effect on Nutrients Level (Harvest)

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