The Impact of Faba Bean Rich Bread on Iron Status, Postprandial Lipaemia and Satiety
NCT Number: NCT06466746
Acronym: RtP
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anemia, Iron Deficiency|Cardiometabolic Disease|Low Iron Stores
Interventions: OTHER: Raising the Pulse faba bean-enriched bread|OTHER: Conventional White Bread
Sponsor: University of Reading
Collaborators: King's College London|University of Leeds
Sex: ALL
Age: ADULT
Enrollment: 16
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-06
Completion Date: 2025-09
Locations: Hugh Sinclair Unit of Human Nutrition, Department of Food and Nutritional Sciences, University of Reading, Reading, Berkshire, RG6 6AP, United Kingdom

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.

Primary Outcome Measures: 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), Day 0 (baseline), day 30 and day 60
Secondary Outcome Measures: 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., 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., 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., 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., 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., 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., 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., Day 0 (baseline), day 30 and day 60|Fasting insulin concentration, Serum insulin will be measured using an enzyme-lined immunosorbent assay., 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., 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., 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., 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., 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., 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., 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., 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, 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, Day 0 (baseline)|Body weight, Body weight will be measured using a Tanita scale., Day 0 (baseline), day 30 and day 60|Body fat percentage, Body fat percentage will be measured using a Tanita scale by bioelectrical impedance., 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., 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)., 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., Day 0 (baseline), day 30 and day 60|Clinic blood pressure, Systolic blood pressure, diastolic blood pressure and pulse pressure, 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., 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., 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., 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, 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, 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.