Ignite Creation Date:
2024-07-17 @ 10:53 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06466746
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-06-04
Brief Title:
The Impact of Faba Bean Rich Bread on Iron Status Postprandial Lipaemia and Satiety
Sponsor:
University of Reading
Organization:
University of Reading
Study Overview
Official Title:
The Impact of Faba Bean Rich Bread on Iron Status Postprandial Lipaemia and Satiety in Adults with Low Iron Stores
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RtP
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 80gday 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
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 eg 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None