NCT03224806

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2014

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2014

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

10 days

First QC Date

July 19, 2017

Last Update Submit

July 19, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Glucose AUC

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

    2 hours

Secondary Outcomes (2)

  • Satiety AUC

    2 hours

  • Hydrolysis index

    2 hours

Study Arms (4)

Wholegrain bread

OTHER
Other: Wholegrain bread

White bread

OTHER
Other: White bread

15% fiber-rich bread

OTHER
Other: 15% fiber-rich bread

30% fiber-rich bread

OTHER
Other: 30% fiber-rich bread

Interventions

156.8g wholegrain bread

Wholegrain bread

122.6g white bread

White bread

139.2g bread made with 15% added wheat bran

15% fiber-rich bread

166.5g bread made with 30% added wheat bran

30% fiber-rich bread

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Good health

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glycemic Index Laboratories, Inc.

Toronto, Ontario, M5C 2X3, Canada

Location

Study Officials

  • Thomas MS Wolever, MD, PhD

    GI Labs

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2017

First Posted

July 21, 2017

Study Start

June 3, 2014

Primary Completion

June 13, 2014

Study Completion

June 13, 2014

Last Updated

July 21, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations