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| Name | Class |
|---|---|
| Norfolk and Norwich University Hospitals NHS Foundation Trust | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary app 1 | Experimental | Dietary app recommends high iron or iron-focused recipes |
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| Dietary app 2 | Sham Comparator | Dietary app recommends standard iron recipes |
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| Hydroponic unit 1 | Experimental | Growing vitamin B12 biofortified plants in a hydroponic unit and will be randomised to dietary app 1 or 2 |
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| Hydroponic unit 2 | No Intervention | No hydroponic unit be given to participants and will be randomised to dietary app 1 or 2 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recipes consumption | Behavioral | Participants will eat two recipes a day for 17 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul A Kroon, PhD | Quadram Institute Bioscience | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quadram Institute Bioscience | Norwich | NR4 7UQ | United Kingdom |
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| ID | Term |
|---|---|
| D000090463 | Iron Deficiencies |
| D014806 | Vitamin B 12 Deficiency |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014804 | Vitamin B Deficiency |
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| Hydroponic unit | Behavioral | Participants will grow vitamin B12 biofortified plants for 17 weeks and consume (10 grams) of plant material for 11 weeks. |
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comparison of FBC in venous blood sample at baseline and after dietary app 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 | comparison of sTfR in venous blood sample at baseline and after dietary app 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 | comparison of AGP in venous blood sample at baseline and after dietary app intervention | 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 | 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 | 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 | Week: 0 and 17 |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |