NCT05740462

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 23, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

May 4, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

July 26, 2024

Status Verified

July 1, 2024

Enrollment Period

2.1 years

First QC Date

February 13, 2023

Last Update Submit

July 25, 2024

Conditions

Iron Deficiency (Without Anemia)B12 Deficiency Vitamin

Keywords

HydroponicDietary appSalad greensIron ferritinVitamin B12vegan recipes

Outcome Measures

Primary Outcomes (2)

  • Change in serum ferritin after the dietary app intervention

    Comparison of serum ferritin at baseline and after the intervention

    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

    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

    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

    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

    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

    Week: 0 and 17

  • Change in holo-transcobalamin (Holo-TC) after the hydroponic unit (biofortification) intervention

    Week: 0 and 17

  • +2 more secondary outcomes

Study Arms (4)

Dietary app 1

EXPERIMENTAL

Dietary app recommends high iron or iron-focused recipes

Behavioral: Recipes consumptionBehavioral: Hydroponic unit

Dietary app 2

SHAM COMPARATOR

Dietary app recommends standard iron recipes

Behavioral: Recipes consumptionBehavioral: 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

Behavioral: Recipes consumptionBehavioral: Hydroponic unit

Hydroponic unit 2

NO INTERVENTION

No hydroponic unit be given to participants and will be randomised to dietary app 1 or 2

Interventions

Recipes consumptionBEHAVIORAL

Participants will eat two recipes a day for 17 weeks

Dietary app 1Dietary app 2Hydroponic unit 1
Hydroponic unitBEHAVIORAL

Participants will grow vitamin B12 biofortified plants for 17 weeks and consume (10 grams) of plant material for 11 weeks.

Dietary app 1Dietary app 2Hydroponic unit 1

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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 \[WHO uses the following cut-offs for context: below 15 µg/L indicates iron deficiency, 16-40 µg/L indicates borderline deficiency, and 41 - 150 µg/L is normal\].
  • 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.

You may not qualify if:

  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quadram Institute Bioscience

Norwich, NR4 7UQ, United Kingdom

Location

MeSH Terms

Conditions

Iron DeficienciesVitamin B 12 Deficiency

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesVitamin B DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition Disorders

Study Officials

  • Paul A Kroon, PhD

    Quadram Institute Bioscience

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2023

First Posted

February 23, 2023

Study Start

May 4, 2023

Primary Completion

June 1, 2025

Study Completion

September 1, 2025

Last Updated

July 26, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)