Anemia, Iron DeficiencyRtPNCT06466746
The Impact of Faba Bean Rich Bread on Iron Status, Postprandial Lipaemia and Satiety
A study testing Raising the Pulse faba bean-enriched bread and Conventional White Bread in people with Anemia, Iron Deficiency and Cardiometabolic Disease, run by University of Reading at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Anemia, Iron Deficiency, Cardiometabolic Disease, Low Iron Stores
- What is being tested?
- Raising the Pulse faba bean-enriched bread and Conventional White Bread
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2024to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 join
- 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
Show all 16Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Hugh Sinclair Unit of Human Nutrition, Department of Food and Nutritional Sciences, University of Reading
Reading, Berkshire, RG6 6AP
Julie Lovegrove, Professor, 0044(0)1183786418, j.a.lovegrove@reading.ac.uk
Kim Jackson, PhD, 0044(0)118378 ext. 5361, k.g.jackson@reading.ac.uk
About this study
Official title: The Impact of Faba Bean Rich Bread on Iron Status, Postprandial Lipaemia and Satiety in Adults with Low Iron Stores
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.
Read more
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.
Read the detailed description
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.
- Being tested
- Raising the Pulse faba bean-enriched bread, Conventional White Bread
- Keywords
- faba bean enriched bread, bioavailability, Enrichment of blood haemoglobin with Iron-57 stable isotope, Postprandial Lipaemia, Satiety, Visual analogue scales, Postprandial glycaemia
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raising the Pulse faba bean-enriched breadOther
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. An ad-libitum lunch consisting of pasta and a tomato sauce will be provide 6 hours after the breakfast.
Conventional White BreadOther
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. An ad-libitum lunch consisting of pasta and a tomato sauce will be provide 6 hours after the breakfast.
| Study group | Role | What they receive |
|---|---|---|
| Faba bean-enriched bread. | Active comparator | 100 g of bread prepared using 40% faba bean flour and 60% wheat flour will be provided in the breakfast test meal. Receives: Other: Raising the Pulse faba bean-enriched bread |
| Conventional white bread | Placebo comparator | 100 g of white bread prepared using 100% wheat flour will be provided in the breakfast test meal. Receives: Other: Conventional White Bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the enrichment of whole blood haemoglobin with iron-57 stable isotope 30 days after consuming the faba bean-enriched bread and conventional bread.
The measurement of iron-57 in whole blood is a validated method for determining the absorption of iron from the bread given in the test meals (also known as bioavailability)
Measured: Day 0 (baseline), day 30 and day 60
Secondary outcomes (28)
Fasting concentrations of iron status markers
Serum ferritin (a measure of the level of iron stored by the body) and soluble transferrin receptor (a measure of functional iron status) will be measured by immunoassay.
Measured: Day 0 (baseline), day 30 and day 60
Fasting concentration of C-reactive protein (a marker of inflammation)
Inflammation, which is characterised by the acute-phase response to infection, can directly affect the concentrations of most iron status markers. C-reactive protein will be measured in the fasting blood sample collected at each study visit to aid the interpretation of the data for the iron status markers.
Measured: Day 0 (baseline), day 30 and day 60
Fasting levels of the full blood count parameters
The level of white blood cells, red blood cells, platelets, haematocrit and haemoglobin in the whole blood sample will be measured using a haematology analyser.
Measured: Day 0 (baseline), day 30 and day 60
Fasting concentration of total cholesterol, high-density lipoprotein-cholesterol, triacylglycerol and non-esterified fatty acids.
Serum lipids will be measured directly using a clinical chemistry analyser.
Measured: Day 0 (baseline), day 30 and day 60
Fasting low-density lipoprotein-cholesterol concentration
The low-density lipoprotein-cholesterol concentration will be calculated from the total cholesterol, high-density lipoprotein-cholesterol and triacylglycerol concentrations using the Friedewald formula.
Measured: Day 0 (baseline), day 30 and day 60
Postprandial concentrations of lipids after consuming the faba bean-enriched bread and control bread.
Serum triacylglycerol and non-esterified fatty acids will be measured in the postprandial blood samples collected for 360 minutes after each acute test meal.
Measured: Acute study on Days 0 and 30, blood taken prior to eating the test meal (0 minutes) and then at 15, 30, 45, 60, 90, 120, 180, 240, 300 and 360 minutes post meal ingestion.
Fasting glucose concentration
Serum glucose will be measured using a clinical chemistry analyser.
Measured: Day 0 (baseline), day 30 and day 60
Fasting insulin concentration
Serum insulin will be measured using an enzyme-lined immunosorbent assay.
Measured: Day 0 (baseline), day 30 and day 60
Fasting estimate of insulin resistance
HOMA-IR (Homeostasis model assessment estimated insulin resistance) will be calculated using the glucose and insulin data.
Measured: Day 0 (baseline), day 30 and day 60
Fasting estimate of insulin sensitivity
QUICKI (Quantitative Insulin Sensitivity Check Index) will be calculated using the glucose and insulin data.
Measured: Day 0 (baseline), day 30 and day 60
Postprandial glucose concentrations after consuming the faba bean-enriched bread and control bread.
Serum glucose will be measured in the postprandial blood samples collected for 360 minutes after each acute test meal.
Measured: Acute study on Days 0 and 30, blood taken prior to eating the test meal (0 minutes) and then at 15, 30, 45, 60, 90, 120, 180, 240, 300 and 360 minutes post meal ingestion
Postprandial insulin concentrations after consuming the faba bean-enriched bread and control bread.
Serum insulin will be measured in the postprandial blood samples collected for 360 minutes after each acute test meal.
Measured: Acute study on Days 0 and 30, blood taken prior to eating the test meal (0 minutes) and then at 15, 30, 45, 60, 90, 120, 180, 240, 300 and 360 minutes post meal ingestion
Fasting and postprandial concentrations of gut hormones
C-peptide, PYY, GIP and GLP-1 will be measured using a Luminex multiplex assay.
Measured: Acute study on Days 0 and 30, blood taken before meal ingestion at 0 minutes and then at 15, 30, 45, 60, 90, 120, 180, 240, 300 and 360 minutes post meal ingestion
Fasting apolipoprotein B concentration
Serum apolipoprotein B will be measured using a clinical chemistry analyser.
Measured: Day 0 (baseline), day 30 and day 60
Postprandial apolipoprotein B concentrations after consuming the faba bean-enriched bread and control bread.
Serum apolipoprotein B concentrations will be measured using a clinical chemistry analyser.
Measured: Acute study on Days 0 and 30, blood taken prior to eating the test meal (0 minutes) and then at 60, 120, 180, 240, 300 and 360 minutes post meal ingestion.
Fasting and postprandial concentrations of amino acids
Individual amino acids
Measured: Acute study on Days 0 and 30, blood taken before eating the test meal (0 minutes) and then at 15, 30, 45, 60, 90, 120, 180, 240, 300 and 360 minutes post meal ingestion
Height
Height will be measured to the nearest cm using a stadiometer
Measured: Day 0 (baseline)
Body weight
Body weight will be measured using a Tanita scale.
Measured: Day 0 (baseline), day 30 and day 60
Body fat percentage
Body fat percentage will be measured using a Tanita scale by bioelectrical impedance.
Measured: Day 0 (baseline), day 30 and day 60
Body fat mass and lean mass
Body fat mass and lean mass will be measured using a Tanita scale by bioelectrical impedance.
Measured: Day 0 (baseline), day 30 and day 60
Body mass index calculation
Body mass index will be calculated using the body weight (kg) and height data (m).
Measured: Day 0 (baseline), day 30 and day 60
Waist and hip circumferences
A non-stretch tape measure will be used to measure the waist and hip circumferences in cm.
Measured: Day 0 (baseline), day 30 and day 60
Clinic blood pressure
Systolic blood pressure, diastolic blood pressure and pulse pressure
Measured: Day 0 (baseline), day 30 and day 60
Postprandial feelings of satiety_7 hour study visit (long day)
100 mm visual analogue scale. This scale is well validated for measuring appetite and satiety. Each rating score is out of 100.
Measured: Acute study on Days 0 and 30, prior to eating the test meal (0 minutes) and then at 15, 30, 60, 120, 240 and 360 minutes post meal ingestion
Postprandial feelings of satiety_2 hour study visit (short day)
100 mm visual analogue scale. This scale is well validated for measuring appetite and satiety. Each rating score is out of 100.
Measured: Days 1, 2, 31 and 32 prior to eating the test meal (0 minutes) and then at 15, 30, 60 and 120 minutes post meal ingestion.
Habitual dietary intake of the study participants
Record of food and drink intake prior to each study visit.
Measured: Day 0 (baseline), day 30 and day 60
Fasting blood samples stored for future ethically approved research related to the project aims and objectives.
Spare whole blood and plasma/serum samples will be collected and biobanked for future research
Measured: Day 0 (baseline), day 30 and day 60
Postprandial blood samples stored for future ethically approved research related to the study aims and objectives.
Spare plasma/serum samples will be biobanked for future research
Measured: Acute study on Days 0 and 30, blood taken prior to eating the test meal (0 minutes) and then at 15, 30, 45, 60, 90, 120, 180, 240, 300 and 360 minutes post meal ingestion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study startSep 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anemia, Iron DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, University of Leeds
- Responsible party
- Principal investigator, Julie Lovegrove, University of Reading
- Investigators
- Abbe Davy, BSc, Study director, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466746
- Sponsor's protocol ID
- UREC 24/02
- Acronym
- RtP
- Status last verified
- Sep 2024
- First submitted
- 4 Jun 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All anonymised IPD that underlie results in a publication and analytic code for the statistical analysis.
Publications
Lovegrove JA, O'Sullivan DM, Tosi P, Millan E, Todman LC, Bishop J, Chatzifragkou A, Clegg ME, Hammond J, Jackson KG, Jones PJ, Lignou S, Macready AL, McMeel Y, Parker J, Rodriguez-Garcia J, Sharp P, Shaw LJ, Smith LG, Tebbit M. 'Raising the Pulse': The environmental, nutritional and health benefits of pulse-enhanced foods. Nutr Bull. 2023 Mar;48(1):134-143. doi: 10.1111/nbu.12601. Epub 2023 Jan 17.
PubMed 36649740
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Faba Bean Rich Bread on Iron Status, Postprandial Lipaemia and Satiety in Adults with Low Iron Stores
- ClinicalTrials.gov ID
- NCT06466746
- Acronym / sponsor ID
- RtP / UREC 24/02
- Keywords
- faba bean enriched bread, bioavailability, Enrichment of blood haemoglobin with Iron-57 stable isotope, Postprandial Lipaemia, Satiety, Visual analogue scales, Postprandial glycaemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- King's College London, University of Leeds
- Study start
- Sep 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 20 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Faba bean-enriched bread. | Active comparator | Other: Raising the Pulse faba bean-enriched bread100 g of bread prepared using 40% faba bean flour and 60% wheat flour will be provided in the breakfast test meal. |
| Conventional white bread | Placebo comparator | Other: Conventional White Bread100 g of white bread prepared using 100% wheat flour will be provided in the breakfast test meal. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Raising the Pulse faba bean-enriched bread100 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. An ad-libitum lunch consisting of pasta and a tomato sauce will be provide 6 hours after the breakfast. | Other | Faba bean-enriched bread. |
| Conventional White Bread100 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. An ad-libitum lunch consisting of pasta and a tomato sauce will be provide 6 hours after the breakfast. | Other | Conventional white bread |
Primary outcome
Change from baseline in the enrichment of whole blood haemoglobin with iron-57 stable isotope 30 days after consuming the faba bean-enriched bread and conventional bread.
Time frame: Day 0 (baseline), day 30 and day 60
The measurement of iron-57 in whole blood is a validated method for determining the absorption of iron from the bread given in the test meals (also known as bioavailability)
28 secondary outcomes
Fasting concentrations of iron status markers
Time frame: Day 0 (baseline), day 30 and day 60
Fasting concentration of C-reactive protein (a marker of inflammation)
Time frame: Day 0 (baseline), day 30 and day 60
Fasting levels of the full blood count parameters
Time frame: Day 0 (baseline), day 30 and day 60
Fasting concentration of total cholesterol, high-density lipoprotein-cholesterol, triacylglycerol and non-esterified fatty acids.
Time frame: Day 0 (baseline), day 30 and day 60
Fasting low-density lipoprotein-cholesterol concentration
Time frame: Day 0 (baseline), day 30 and day 60
Postprandial concentrations of lipids after consuming the faba bean-enriched bread and control bread.
Time frame: Acute study on Days 0 and 30, blood taken prior to eating the test meal (0 minutes) and then at 15, 30, 45, 60, 90, 120, 180, 240, 300 and 360 minutes post meal ingestion.
Fasting glucose concentration
Time frame: Day 0 (baseline), day 30 and day 60
Fasting insulin concentration
Time frame: Day 0 (baseline), day 30 and day 60
Fasting estimate of insulin resistance
Time frame: Day 0 (baseline), day 30 and day 60
Fasting estimate of insulin sensitivity
Time frame: Day 0 (baseline), day 30 and day 60
Postprandial glucose concentrations after consuming the faba bean-enriched bread and control bread.
Time frame: Acute study on Days 0 and 30, blood taken prior to eating the test meal (0 minutes) and then at 15, 30, 45, 60, 90, 120, 180, 240, 300 and 360 minutes post meal ingestion
Postprandial insulin concentrations after consuming the faba bean-enriched bread and control bread.
Time frame: Acute study on Days 0 and 30, blood taken prior to eating the test meal (0 minutes) and then at 15, 30, 45, 60, 90, 120, 180, 240, 300 and 360 minutes post meal ingestion
Fasting and postprandial concentrations of gut hormones
Time frame: Acute study on Days 0 and 30, blood taken before meal ingestion at 0 minutes and then at 15, 30, 45, 60, 90, 120, 180, 240, 300 and 360 minutes post meal ingestion
Fasting apolipoprotein B concentration
Time frame: Day 0 (baseline), day 30 and day 60
Postprandial apolipoprotein B concentrations after consuming the faba bean-enriched bread and control bread.
Time frame: Acute study on Days 0 and 30, blood taken prior to eating the test meal (0 minutes) and then at 60, 120, 180, 240, 300 and 360 minutes post meal ingestion.
Fasting and postprandial concentrations of amino acids
Time frame: Acute study on Days 0 and 30, blood taken before eating the test meal (0 minutes) and then at 15, 30, 45, 60, 90, 120, 180, 240, 300 and 360 minutes post meal ingestion
Height
Time frame: Day 0 (baseline)
Body weight
Time frame: Day 0 (baseline), day 30 and day 60
Body fat percentage
Time frame: Day 0 (baseline), day 30 and day 60
Body fat mass and lean mass
Time frame: Day 0 (baseline), day 30 and day 60
Body mass index calculation
Time frame: Day 0 (baseline), day 30 and day 60
Waist and hip circumferences
Time frame: Day 0 (baseline), day 30 and day 60
Clinic blood pressure
Time frame: Day 0 (baseline), day 30 and day 60
Postprandial feelings of satiety_7 hour study visit (long day)
Time frame: Acute study on Days 0 and 30, prior to eating the test meal (0 minutes) and then at 15, 30, 60, 120, 240 and 360 minutes post meal ingestion
Postprandial feelings of satiety_2 hour study visit (short day)
Time frame: Days 1, 2, 31 and 32 prior to eating the test meal (0 minutes) and then at 15, 30, 60 and 120 minutes post meal ingestion.
Habitual dietary intake of the study participants
Time frame: Day 0 (baseline), day 30 and day 60
Fasting blood samples stored for future ethically approved research related to the project aims and objectives.
Time frame: Day 0 (baseline), day 30 and day 60
Postprandial blood samples stored for future ethically approved research related to the study aims and objectives.
Time frame: Acute study on Days 0 and 30, blood taken prior to eating the test meal (0 minutes) and then at 15, 30, 45, 60, 90, 120, 180, 240, 300 and 360 minutes post meal ingestion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 36649740Lovegrove JA, O'Sullivan DM, Tosi P, Millan E, Todman LC, Bishop J, Chatzifragkou A, Clegg ME, Hammond J, Jackson KG, Jones PJ, Lignou S, Macready AL, McMeel Y, Parker J, Rodriguez-Garcia J, Sharp P, Shaw LJ, Smith LG, Tebbit M. 'Raising the Pulse': The environmental, nutritional and health benefits of pulse-enhanced foods. Nutr Bull. 2023 Mar;48(1):134-143. doi: 10.1111/nbu.12601. Epub 2023 Jan 17.
- Individual participant dataSharing planned: Yes. All anonymised IPD that underlie results in a publication and analytic code for the statistical analysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abbe Davy, BSc study director
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Raising the Pulse faba bean-enriched bread and Conventional White Bread in people with Anemia, Iron Deficiency and Cardiometabolic Disease, run by University of Reading at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie A Lovegrove, BSc PhD (011 44 118 378 6418, j.a.lovegrove@reading.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the enrichment of whole blood haemoglobin with iron-57 stable isotope 30 days after consuming the faba bean-enriched bread and conventional bread. (time frame: Day 0 (baseline), day 30 and day 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06466746, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.