Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05740462
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-01-16
First Post:
2023-02-13
Brief Title:
Hydroponic Fortification and Dietary App Effect on Nutrients Level Harvest
Sponsor:
Quadram Institute Bioscience
Organization:
Quadram Institute Bioscience
Study Overview
Official Title:
Hydroponic Fortification and Dietary App Effect on Vitamin B12 and Iron Fe Status - The Harvest Study A Randomised Double-blinded Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 87 mgday for men over 18 and women over 50 148 mgday 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 15 µgday therefore it is crucial that vegans and vegetarians take B12 supplements if they dont 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
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 15 µgday therefore it is crucial that vegans and vegetarians take B12 supplements if they dont 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None