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Completed

NCT Number: NCT05526937

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

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Nutraceutical Research Unit

Guelph, Ontario, N1G 2W1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bread

Other

Bread portions of 50 gram available carbohydrates.

Primary outcomes

  1. Postprandial glycemic response

    Time frame: 2 hours

    Capillary blood glucose

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

University of Guelph

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 2, 2022
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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