At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Raising the Pulse faba bean-enriched bread (other), Conventional White Bread (other)
- How long the study runs
- Study runs about 12 months (dates as stated)
- About the drug or intervention
- Raising the Pulse faba bean-enriched bread — other: 100 g of white bread produced using 40% faba bean enriched flour and 60% wheat flour will be provided in the breakfast meal with stork margarine, chocolate spread, a glass of orange juice and a glass of water containing the iron-57 stable isotope. · Conventional White Bread — other: 100 g of white bread produced using 100% wheat flour will be provided in the breakfast meal with stork margarine, chocolate spread, a glass of orange juice and a glass of water containing the iron-57 stable isotope.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 50 Years
- Who
- All
- Number of participants
- 16
- Started
- 2024-09
- Last checked
- 2024-09
Plain English Summary
What is this study?
- • Testing a new treatment for anemia, iron deficiency
- • NA - 16 participants
- • 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
Who can take part?
- • Ages 18 Years to 50 Years
- • Diagnosed with anemia, iron deficiency
Where?
- • Reading - Hugh Sinclair Unit of Human Nutrition, Department of Food and Nutritional Sciences, University of Reading
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
Since higher dietary intakes of animal protein (meat) are linked with heart disease and other long-term health problems, there has been a shift in recent years to consuming more plant-based foods. Legumes (e.g. beans) provide a sustainable and nutritious source of protein and are higher in fibre and micronutrients (such as iron) compared with staple cereals. Higher intakes of pulses lower blood sugar and fat levels, increase feelings of fullness (satiety) and reduce blood pressure. The higher iron content in mature faba beans may also help to reduce iron-deficiency anaemia, the most common diet-related deficiency. However, studies have suggested that the absorption of iron from pulses (known as bioavailability) is lower than from meat due to the presence of compounds in plants that interfere with absorption (anti-nutrients). Processing techniques such as milling of faba beans are considered to lower or even eliminate these compounds. In the Raising the Pulse (RtP) project, flour milled from homegrown faba beans will be used to produce a pulse-enriched loaf which could be adopted in the UK diet and benefit both health and the environment. However, very little is known about how bread enriched with pulses may influence firstly, iron bioavailability and secondly, blood sugar and fat levels which are common risk factors for developing heart disease and diabetes. This randomised controlled cross-over study will aim to recruit 16 healthy, non-anaemic males and females with low iron stores. Aside from the screening visit where participants will be assessed for eligibility and consent for participation gained, this study will involve seven study visits. The first study visit (Day 1) will be approximately 7 hours (420 minutes) in duration and participants will be randomly assigned to consume either the faba bean-enriched bread or the conventional white bread along with a drink containing iron-57, a naturally occurring non-radioactive form of iron found in very low levels in the diet (stable isotope) to measure iron absorption. Blood samples will be collected to measure blood haemoglobin, sugar and fat levels as well as hormones known to impact appetite, and participants will be asked to complete visual analogue scales to rate their appetite. At the visit, an ad-libitum (unrestricted) meal will be provided 6 hours after eating the test breakfast and the amount of food eaten will be used to assess satiety. Participants will then return on days 2 and 3 to consume the same test meal and complete visual analogue scales to rate appetite for 2 hours. At day 30, participants will return for the second 7 hour (420 minute) study visit to consume the other type of bread and return on days 31 and 32 for the shorter study visits. The day 30 fasting blood sample will be used to measure the enrichment of blood haemoglobin with iron-57 to determine the amount of iron absorbed from the test bread given on day 0. On day 60, participants will return to the clinical unit to give a final fasting blood sample to measure iron bioavailability (enrichment of blood haemoglobin with iron-57) from the test bread given on day 30. Dietary intake will also be recorded.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 50 Years
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ regular periods)
What the study is looking for
- ✓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)
Who cannot take part
- ✗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)
See the full criteria
Where Is This Study? (1 UK site)
Hugh Sinclair Unit of Human Nutrition, Department of Food and Nutritional Sciences, University of Reading
Reading RG6 6AP, United Kingdom
How to Get in Touch
Julie A Lovegrove, BSc PhD
Sponsor contactCONTACT
Kim G Jackson, BSc PhD
Sponsor contactCONTACT
