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Completed

NCT Number: NCT03224806

Effect of Fiber Composite-enriched Breads on Glycemic Responses

Health organizations recommend fiber-rich and whole-grain foods for healthy diets due to their physiological beneficial effects on human health. But, little information is available between these 2 food categories, i.e. fiber added to foods versus fiber naturally present in foods. The present study investigated the effect of enriching white wheat flour with wheat bran at 2 levels (15 and 30%) to produce 15% fiber-rich bread (15FRB) and 30% fiber-rich bread (30FRB) and compared them with white bread (WB) and whole-grain bread (WGB) in terms of bread quality, palatability, satiety, and glycemic response. Ten healthy subjects were studied on 4 separate days with each subject testing all 4 types of bread. On each test day subjects came to the test center after an overnight fast. After 2 fasting finger-prick blood samples, they ate a portion of one of the breads containing 50g available carbohydrate and had further blood samples at intervals over 2 hours. They also rated their feelings of satiety fasting and at intervals over 2 hours.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Glycemic Index Laboratories, Inc.

Toronto, Ontario, M5C 2X3, Canada

About this study

Health organizations recommend fiber-rich and whole-grain foods for healthy diets due to their physiological beneficial effects on human health. But, little information is available between these 2 food categories, i.e. fiber added to foods versus fiber naturally present in foods. The present study investigated the effect of enriching white wheat flour with wheat bran at 2 levels (15 and 30%) to produce 15% fiber-rich bread (15FRB) and 30% fiber-rich bread (30FRB) and compared them with white bread (WB) and whole-grain bread (WGB) in terms of bread quality, palatability, satiety, and glycemic response. Ten healthy subjects were studied on 4 separate days with each subject testing all 4 types of bread. On each test day subjects came to the test center after an overnight fast. After 2 fasting finger-prick blood samples 5 minutes apart, they ate a portion of one of the breads containing 50g available carbohydrate and had further blood samples at 15, 30, 45, 60,90 and 120 min after starting to eat. After each blood sample also rated their feelings of satiety on a 7-point scale from extremely hungry to extremely full.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Good health

Exclusion criteria

  • Known history of AIDS, hepatitis, diabetes or a heart condition
  • Use of drugs which would increase risk to the subject or affect the results in the opinion of the medical director
  • Any condition which would increase risk to the subject or affect the results in the opinion of the medical director
  • Individuals who cannot or will not comply with experimental procedures or do not follow safety guidelines.

Treatment and study plan

Wholegrain bread

Other

156.8g wholegrain bread

White Bread

Other

122.6g white bread

15% fiber-rich bread

Other

139.2g bread made with 15% added wheat bran

30% fiber-rich bread

Other

166.5g bread made with 30% added wheat bran

Primary outcomes

  1. Glucose AUC

    Time frame: 2 hours

    Incremental area under the glucose response curve ignoring area below fasting glucose

Secondary outcomes

  1. Satiety AUC

    Time frame: 2 hours

    Incremental area under the satiety response curve

  2. Hydrolysis index

    Time frame: 2 hours

    Incremental area under the hydrolysis curve (amount of glucose released during in-vitro digestion of the breads) expressed as a percentage of that for white bread.

Sponsors and collaborators

Lead sponsor

Glycemic Index Laboratories, Inc

Industry

Collaborators

  • Guelph Research and Development Centre, Agriculture and Agri-Food Canada
  • University of Guelph

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 21, 2017
Registry last updated
Jul 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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