- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05526937
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
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.
Sponsor
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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