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

Recruiting now · Not applicable

Conditions studied: Anemia, Iron Deficiency, Cardiometabolic Disease, Low Iron Stores

In brief

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.

Key facts

Study ID: NCT06466746
Run by: University of Reading
People needed: 16
Starts: 2024-09-01
Expected to finish: 2025-09-01
Last updated by the study team: 2024-09-19

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

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
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)

Where it is running

Hugh Sinclair Unit of Human Nutrition, Department of Food and Nutritional Sciences, University of Reading — Reading, Berkshire, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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