Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
All Genders
Healthy Volunteers
NCT06466746

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

Led by University of Reading · Updated on 2024-09-19

16

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

U

University of Reading

Lead Sponsor

K

King's College London

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 50Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Non-anaemic males and pre-menopausal females with regular periods
  • Aged 18 to 50 years old
  • BMI between 19 and 30 kg/m2
  • Low iron stores (serum ferritin 13-40 bcg/L for females; 30-90 bcg/L for males)
Not Eligible

You will not qualify if you...

  • Allergies or intolerances to faba beans (favism) or gluten
  • Diagnosed anemia (hemoglobin <115 g/L for females, <130 g/L for males) or haemochromatosis
  • C-reactive protein >3 mg/L
  • Smokers
  • History of alcohol abuse (>14 units/week)
  • Cardiovascular disease, myocardial infarction, or stroke within past 12 months
  • Diabetes (fasting glucose >7.0 mmol/L)
  • Kidney, liver, pancreas, intestinal disease, gastrointestinal disorder, or use of drugs affecting gastrointestinal function
  • Pregnancy, planning pregnancy within 6 months, or breastfeeding
  • Peri- or post-menopausal women or women with irregular periods
  • Planning weight loss regimen or lost >3 kg in last 6 months
  • Participation in another intervention study
  • Hypertension (blood pressure >140/90 mmHg), cancer, taking statins, or inflammation
  • Taking vitamin or mineral supplements
  • Donated blood in last 3 months
  • Other medical history or lifestyle factors preventing participation, such as having a pacemaker

AI-Screening

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Trial Site Locations

Total: 1 location

1

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

Reading, Berkshire, United Kingdom, RG6 6AP

Actively Recruiting

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Research Team

J

Julie A Lovegrove, BSc PhD

CONTACT

K

Kim G Jackson, BSc PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

PREVENTION

Number of Arms

2

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