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

NCT ID: NCT05526937

Last Updated: 2023-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-18

Study Completion Date

2023-05-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Blood Sugar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Sprouted wholemeal bread

Group Type EXPERIMENTAL

Bread

Intervention Type OTHER

Bread portions of 50 gram available carbohydrates.

Unsprouted wholemeal bread

Group Type ACTIVE_COMPARATOR

Bread

Intervention Type OTHER

Bread portions of 50 gram available carbohydrates.

White bread

Group Type PLACEBO_COMPARATOR

Bread

Intervention Type OTHER

Bread portions of 50 gram available carbohydrates.

Interventions

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Bread

Bread portions of 50 gram available carbohydrates.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Guelph

OTHER

Sponsor Role lead

Responsible Party

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Amanda Wright, Ph.D.

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Human Nutraceutical Research Unit

Guelph, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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22-06-26

Identifier Type: -

Identifier Source: org_study_id