The Impact of Faba Bean Rich Bread on Iron Status, Postprandial Lipaemia and Satiety

NCT06466746 | Recruiting

• 1 other identifier: UREC 24/02
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia, Iron Deficiency; Cardiometabolic Disease; Low Iron Stores

Keywords

faba bean enriched bread; bioavailability; Enrichment of blood haemoglobin with Iron-57 stable isotope; Postprandial Lipaemia; Satiety; Visual analogue scales; Postprandial glycaemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (28)

• Fasting concentrations of iron status markers

  Day 0 (baseline), day 30 and day 60

• Fasting concentration of C-reactive protein (a marker of inflammation)

  Day 0 (baseline), day 30 and day 60

• Fasting levels of the full blood count parameters

  Day 0 (baseline), day 30 and day 60

• Fasting concentration of total cholesterol, high-density lipoprotein-cholesterol, triacylglycerol and non-esterified fatty acids.

  Day 0 (baseline), day 30 and day 60

• Fasting low-density lipoprotein-cholesterol concentration

  Day 0 (baseline), day 30 and day 60

Study Arms (2)

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.

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.

Other: Conventional White Bread

Interventions

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. An ad-libitum lunch consisting of pasta and a tomato sauce will be provide 6 hours after the breakfast.

Faba bean-enriched bread.

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. An ad-libitum lunch consisting of pasta and a tomato sauce will be provide 6 hours after the breakfast.

Conventional white bread

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Reading: lead
• King's College London: collaborator
• University of Leeds: collaborator

Study Sites (1)

Hugh Sinclair Unit of Human Nutrition, Department of Food and Nutritional Sciences, University of Reading

Reading, Berkshire, RG6 6AP, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 36649740 BACKGROUND

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Abbe Davy, BSc

  University of Reading

  STUDY DIRECTOR

Central Study Contacts

Julie A Lovegrove, BSc PhD

CONTACT

011 44 118 378 6418; j.a.lovegrove@reading.ac.uk

Kim G Jackson, BSc PhD

CONTACT

011 44 118 378 5361; k.g.jackson@reading.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Human Nutrition and Director of the Hugh Sinclair Unit of Human Nutrition

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 20, 2024
• Study Start: September 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Anonymised data will be made available on reasonable request one year after manuscripts have been published.
• Access Criteria: For data sharing and preservation, anonymised IPD will be archived in the University of Reading Research Data Archive. Access will be overseen by the project PI. This information will be maintained under Professor Julie Lovegrove's and Dr Kim Jackson's authority and disposed of appropriately by the PI \[Professor Julie Lovegrove\]. If the PI should leave the University, the Personal Information will be under the authority of the Head of School.

Locations

GB (1)