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

NCT05526937 | Completed

• 1 other identifier: 22-06-26
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Blood Sugar

Outcome Measures

Primary Outcomes (1)

• Postprandial glycemic response

  Capillary blood glucose

  2 hours

Secondary Outcomes (1)

• Postprandial satiety response

  2 hours

Study Arms (3)

Sprouted wholemeal bread

EXPERIMENTAL

Other: Bread

Unsprouted wholemeal bread

ACTIVE COMPARATOR

Other: Bread

White bread

PLACEBO COMPARATOR

Other: Bread

Interventions

Bread OTHER

Bread portions of 50 gram available carbohydrates.

Sprouted wholemeal bread; Unsprouted wholemeal bread; White bread

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Guelph: lead

Study Sites (1)

Human Nutraceutical Research Unit

Guelph, Ontario, N1G 2W1, Canada

Location

MeSH Terms

Interventions

Bread

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: September 2, 2022
• Study Start: October 18, 2022
• Primary Completion: March 15, 2023
• Study Completion: May 15, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)