The Effect of Sprouting of Wheat on Postprandial Glycemic and Satiety Responses of Wheat Bread Products

December 4, 2023 updated by: Amanda Wright, Ph.D., University of Guelph
The objective of this study is to investigate the effect of inclusion of 50% sprouted wheat wholemeal in a bread recipe on the postprandial glycemic and satiety responses, as well as on appetite-related sensations and acceptability of the developed products relative to a product made with a similar unsprouted wheat recipe.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a randomized crossover trial involving three different bread products. At each study visit, capillary blood glucose will be measured at fasting, and then 15, 30, 45, 60, 90, and 120 minutes following the start of ingestion of the study food. Visual analogue scales will be used to assess appetite and fullness sensations at fasting, and then 30, 60, 90 and 120 minutes.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Guelph, Ontario, Canada, N1G 2W1
        • Human Nutraceutical Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy adults
  • Age 18-40 years
  • Normal non-fasting plasma glucose (<7.9 mmol/L but not below 3.3 mmol/L)
  • BMI ranging from 18.5 to 27.9 kg/m2
  • Regular consumer of wheat-based bread products (>1x per week).

Exclusion Criteria:

  • Smoking or regular use of recreational drugs (marijuana, ecstasy, LSD, magic mushrooms etc.)
  • Heavy alcohol use (defined as typically >14 drinks per week or >4 drinks on one occasion)
  • Restrained eater (>16) as defined by the questionnaire at screening (Appendix E: Three Factor Eating Questionnaire, Stunkard et al.,1985)
  • Unusual sleep patterns (Shift-worker, or sleeps 4 hours or less regularly) or irregular breakfast consumption.
  • Recent (i.e. >4 kg in previous 3 months) or intended weight loss or gain
  • Food allergies or any life-threatening allergy (food or otherwise)
  • Gluten intolerance or sensitivity
  • Medications known to affect glucose tolerance (excluding oral contraceptives)
  • Presence of disease or drug(s) which influence digestion and absorption of nutrients; including steroids, protease inhibitors or antipsychotics.
  • Inability to adhere to Study Protocols

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: White bread
Bread portions of 50 gram available carbohydrates.
Experimental: Sprouted wholemeal bread
Bread portions of 50 gram available carbohydrates.
Active Comparator: Unsprouted wholemeal bread
Bread portions of 50 gram available carbohydrates.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postprandial glycemic response
Time Frame: 2 hours
Capillary blood glucose
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postprandial satiety response
Time Frame: 2 hours
Hunger, Fullness, Desire to Eat and Prospective Food Consumption questions using Visual Analogue Scales (100 mm lines). Answers are measured and scored from 0 (not at all) to 100 (extreme).
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2022

Primary Completion (Actual)

March 15, 2023

Study Completion (Actual)

May 15, 2023

Study Registration Dates

First Submitted

August 31, 2022

First Submitted That Met QC Criteria

August 31, 2022

First Posted (Actual)

September 2, 2022

Study Record Updates

Last Update Posted (Estimated)

December 5, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 22-06-26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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