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

Blood Sugar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05526937
• Other study ID #: 22-06-26
• Status: Completed
• Phase: N/A
• Start date: October 18, 2022
• Est. completion date: May 15, 2023

Study information

• Verified date: December 2023
• Source: University of Guelph
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 15, 2023
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Sugar

Intervention

Other:
• Bread
Bread portions of 50 gram available carbohydrates.

Locations

Country	Name	City	State
Canada	Human Nutraceutical Research Unit	Guelph	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Guelph

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial glycemic response	Capillary blood glucose	2 hours
Secondary	Postprandial satiety response	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