NCT06466746 The Impact of Faba Bean Rich Bread on Iron Status, Postprandial Lipaemia and Satiety
| NCT ID | NCT06466746 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Reading |
| Condition | Anemia, Iron Deficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 16 participants |
| Start Date | 2024-09 |
| Primary Completion | 2025-06 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 16 participants in total. It began in 2024-09 with a primary completion date of 2025-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
High levels of animal proteins (meat) in the diet are linked with a greater risk of developing heart disease and other long-term health conditions. Recently there has been a shift to plant-based diets including plant proteins such as pulses, defined as beans, peas, chickpeas and lentils. Pulses are a nutritious and sustainable form of plant protein which are rich in fibre and iron. Despite this, the UK population does not consume the recommended daily amount of pulses (80g/day equivalent to a large handful). In contrast, bread is commonly consumed but very little is known about how bread enriched with pulses influences the amount of iron that is digested and absorbed by the body as well as risk factors for developing heart disease and type 2 diabetes. The main purpose of this randomised controlled cross-over study is to determine how consuming bread enriched with pulses (in the form of faba bean flour at approximately 40% enrichment) compared with conventional white bread (100% wheat flour) influences the amount of iron absorbed in healthy males and females aged 18-50 years with low iron stores. Secondary aims are determining the effects on blood fats and sugar (glucose) and on feelings of fullness (also known as satiety) after eating the bread enriched in pulses and conventional white bread. Participants will be required: * To attend for seven study visits over a period of 60 days. * Consume a breakfast meal containing either the faba bean-enriched bread or conventional bread over two study periods, each consisting of one 7 hour study visit and two consecutive visits of 2 hours in duration. After 28 days, participants will return for the second study period as above, with a final study visit conducted 28 days later. * Give blood samples during 2 x 7 hour study visits * Complete visual analogue scales to rate appetite after consuming the faba bean-enriched and conventional white bread. * Record dietary intake prior to and during the study period.
Eligibility Criteria
Inclusion Criteria: * Non-anaemic, males and pre-menopausal females (must have regular periods) * Aged 18-50 years old * BMI between 19 - 30 kg/m2 * Low iron stores (serum ferritin between 13-40 µg/L for females and 30-90 µg/L for males) Exclusion Criteria: * Food allergies or intolerances to faba beans (favism) or gluten * Diagnosed with anaemia (haemoglobin \<115 g/L for females or \<130 g/L for males) or haemochromatosis * C-reactive protein (\>3mg/L) * Smokers * A history of alcohol abuse (\> 14 units/ week) * CVD or medical history of MI or stroke in the past 12 months * Diabetes (fasting glucose \>7.0 mmol/L) * Kidney, liver, pancreas or intestinal disease, gastrointestinal disorder or use of drugs likely to alter gastrointestinal function * Pregnancy, planning a pregnancy in the next six months or breastfeeding * Peri- and post-menopausal women or women with irregular periods * Planning on a weight-reducing regimen (lost \>3kg in last 6 months) * Parallel participation in another intervention study * Hypertension (blood pressure \> 140/90 mmHg), cancer, taking medication for hyperlipidaemia (statins), or inflammation * Taking vitamin or mineral supplements * Donated blood in the last 3 months * Any other unusual medical history or diet and lifestyle habits or practices that would preclude volunteers from participating in a dietary intervention and metabolic study (such as a pacemaker)
Contact & Investigator
Abbe Davy, BSc
STUDY DIRECTOR
University of Reading
Frequently Asked Questions
Who can join the NCT06466746 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Anemia, Iron Deficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06466746 currently recruiting?
Yes, NCT06466746 is actively recruiting participants. Contact the research team at j.a.lovegrove@reading.ac.uk for enrollment information.
Where is the NCT06466746 trial being conducted?
This trial is being conducted at Reading, United Kingdom.
Who is sponsoring the NCT06466746 clinical trial?
NCT06466746 is sponsored by University of Reading. The principal investigator is Abbe Davy, BSc at University of Reading. The trial plans to enroll 16 participants.