Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
All Genders
Healthy Volunteers
ID06466746

The Impact of Faba Bean Rich Bread on Iron Status, Postprandial Lipaemia and Satiety in Adults with Low Iron Stores

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

16

Participants Needed

1

Research Sites

13 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

Researchers are studying how bread enriched with pulses, specifically faba bean flour, affects iron absorption and markers related to heart disease and type 2 diabetes in healthy adults aged 18 to 50 years with low iron stores. The study aims to compare this pulse-enriched bread to conventional white bread to understand its impact on iron bioavailability, blood fats, blood sugar, and feelings of fullness. This randomized controlled cross-over study includes both males and females with normal hemoglobin but low serum ferritin levels. Participants will consume two types of bread during two study periods: bread made with 40% faba bean flour and conventional white bread made from 100% wheat flour. Each period involves a 7-hour study visit followed by two consecutive 2-hour visits. Meals include a breakfast containing the test bread, margarine, chocolate spread, orange juice, and water with a stable iron isotope to track iron absorption, plus an unrestricted lunch six hours later. After 28 days, participants switch to the other bread type and repeat the visits, with a final blood sample taken 60 days after the initial visit. During the study, participants will provide blood samples to measure iron status, blood fats, glucose, insulin, and hormones related to appetite. They will complete appetite rating scales and record their dietary intake before and during the study. Researchers will assess iron absorption by measuring iron isotope enrichment in blood hemoglobin, monitor post-meal blood sugar and fat levels, and evaluate feelings of fullness. The total participation spans about 60 days, including multiple visits for blood collection and appetite assessments.

CONDITIONS

Brief 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
  • Body mass index between 19 and 30 kg/m2
  • Low iron stores with serum ferritin 13-40 g/L for females and 30-90 g/L for males
Not Eligible

You will not qualify if you...

  • Food allergies or intolerances to faba beans (favism) or gluten
  • Diagnosed anemia or haemochromatosis
  • Elevated C-reactive protein over 3 mg/L
  • Current smoker
  • History of alcohol abuse over 14 units per week
  • Cardiovascular disease or history of heart attack or stroke in past 12 months
  • Diabetes with fasting glucose over 7.0 mmol/L
  • Disease or medication affecting gastrointestinal function
  • Pregnancy, planning pregnancy within 6 months, or breastfeeding
  • Peri- or post-menopausal women or irregular menstrual periods
  • Recently lost more than 3 kg in last 6 months or on weight-reducing diets
  • Participation in another intervention study
  • Hypertension over 140/90 mmHg, cancer, or taking statins
  • Taking vitamin or mineral supplements
  • Donated blood within last 3 months
  • Any other medical or lifestyle conditions preventing participation in dietary intervention and metabolic study such as having a pacemaker

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 2 months

Participants consume either faba bean-enriched bread or conventional white bread during two separate 7-hour study visits with follow-up visits to assess iron absorption, blood markers, and feelings of fullness.

7 study visits: 2 long 7-hour visits on Days 0 and 30 and 5 shorter visits on Days 1, 2, 31, 32, and 60

Follow-up

Duration - Day 60 (final visit after treatment completion)

Participants return for a final fasting blood sample to measure iron bioavailability and other health markers.

1 visit (in-person)

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

K

Kim G Jackson, BSc PhD

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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