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Completed

NCT Number: NCT06005415

Glycemic Response to an Innovative Cookie to Promote Human Health

The aim of this study is to investigate whether using a coarse wheat fraction in wire-cut cookie making induces a lower glycemic response in healthy subjects compared to wheat flour.

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Key information

Conditions

Postprandial Glycemic Responses

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KU Leuven/UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

About this study

This study has a double-blind, randomized, cross-over design. During each of the two study visits, healthy participants will consume a standard portion of cookies. One cookie formulation will present a large amount of coarse wheat fraction, while the other formulation will include only wheat flour and will serve as a control. Blood glucose measurements will be taken postprandially at regular time points. Gastric emptying rate and oral processing behavior will be also object of study.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body mass index (BMI) range 18.5 - 25.0 kg/m2 at screening visit
  • Fasting whole blood glucose values < 6.3 mmol/L
  • Regular diet with 3 meals a day (at least 5 times a week)
  • Absence of health conditions that would prevent fulfillment of study requirements as judged by the Investigators on the basis of medical history
  • Willingness to maintain habitual diet, physical activity pattern, and body weight throughout the trial
  • Willingness to abstain from alcohol consumption and to avoid vigorous physical activity for 24 h prior to study visits
  • Adequate level of understanding spoken and written English
  • Willingness to report lifestyle factors such as level of physical activity and perceived psychological stress
  • Willingness to provide informed consent to participate in the study

Exclusion criteria

  • Failure to meet any one of the inclusion criteria
  • Recent participation in any clinical trial (< 90 days)
  • Pregnant or lactating or wishing to become pregnant in the period of the study
  • Known history of AIDS, hepatitis, diabetes mellitus (Type I and II), cardiovascular disease, any pathology (or recent surgical event) of the gastrointestinal system or any current metabolic or endocrine disease
  • Alcohol consumption of > 14 standard drinks for women and > 21 standard drinks for men per week
  • Currently smoking (have smoked in the last 28 days) or willingness to smoke during the study period
  • Celiac disease or gluten intolerance
  • Use of medications known to influence carbohydrate metabolism, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids the last 4 weeks before the screening visit
  • Use of antibiotics during the last three months
  • Reported slimming or medically prescribed diet
  • Unwillingness or inability to comply with the experimental procedures and to follow the safety guidelines

Treatment and study plan

Wire-cut cookie

Dietary Supplement

Investigation of the impact of wheat particle size on the postprandial glycemic response, gastric emptying and oral processing behavior after consumption of wire-cut cookies.

Primary outcomes

  1. Glucose response

    Time frame: 10, 5 minute before and 10, 20, 30, 45, 60, 75, 90, 120, 150 and 180 minutes after consumption of test meal, both test day 1 and 2

    Incremental area under the curve of blood glucose concentration (mM) after wheat-based wire-cut cookie consumption, measured through blood samples collected via finger-prick before eating (i.e. 10 and 5 minutes before ingestion) and at respective time points after consumption of test meal (i.e. 10, 20, 30, 45, 60, 75, 90, 120, 150 and 180 minutes).

Secondary outcomes

  1. Peak rise of blood glucose

    Time frame: 10, 5 minute before and 10, 20, 30, 45, 60, 75, 90, 120, 150 and 180 minutes after consumption of test meal, both test day 1 and 2

    Difference between the highest postprandial blood glucose concentration and the baseline (expressed in mM), measured through blood samples collected via finger-prick before eating (i.e. 10 and 5 minutes before ingestion) and at respective time points after consumption of test meal (i.e. 10, 20, 30, 45, 60, 75, 90, 120, 150 and 180 minutes).

  2. Gastric emptying rate

    Time frame: 0, 10, 20, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes after consumption of test meal, on test day 1

    Measured through 13C-octanoic acid breath samples collected before eating (i.e. 0 minute) and at respective time points after consumption of test meal (i.e. 10, 20, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes).

  3. Gastric emptying rate

    Time frame: 0, 10, 20, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes after consumption of test meal, on test day 2

    Measured through 13C-octanoic acid breath samples collected before eating (i.e. 0 minute) and at respective time points after consumption of test meal (i.e. 10, 20, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes).

  4. Oral processing behavior (exposure time)

    Time frame: During test meal consumption, up to 10 minutes, on test day 1

    Participants will be video-recorded to analyze oral processing behavior of the test meal. Number of bites, chews, swallows and time in mouth (s) will be annotated to derive total oral exposure time (s).

  5. Oral processing behavior (exposure time)

    Time frame: During test meal consumption, up to 10 minutes, on test day 2

    Participants will be video-recorded to analyze oral processing behavior of the test meal. Number of bites, chews, swallows and time in mouth (s) will be annotated to derive total oral exposure time (s).

  6. Oral processing behavior (average bite size)

    Time frame: During test meal consumption, up to 10 minutes, on test day 1

    Participants will be video-recorded to analyze oral processing behavior of the test meal. Number of bites, chews, swallows and time in mouth (s) will be annotated to derive total average bite size (g per bite).

  7. Oral processing behavior (average bite size)

    Time frame: During test meal consumption, up to 10 minutes, on test day 2

    Participants will be video-recorded to analyze oral processing behavior of the test meal. Number of bites, chews, swallows and time in mouth (s) will be annotated to derive total average bite size (g per bite).

  8. Oral processing behavior (average chews per bite)

    Time frame: During test meal consumption, up to 10 minutes, on test day 1

    Participants will be video-recorded to analyze oral processing behavior of the test meal. Number of bites, chews, swallows and time in mouth (s) will be annotated to derive total average chews per bite.

  9. Oral processing behavior (average chews per bite)

    Time frame: During test meal consumption, up to 10 minutes, on test day 2

    Participants will be video-recorded to analyze oral processing behavior of the test meal. Number of bites, chews, swallows and time in mouth (s) will be annotated to derive total average chews per bite.

  10. Oral processing behavior (eating rate)

    Time frame: During test meal consumption, up to 10 minutes, on test day 1

    Participants will be video-recorded to analyze oral processing behavior of the test meal. Number of bites, chews, swallows and time in mouth (s) will be annotated to derive total eating rate (g per minute).

  11. Oral processing behavior (eating rate)

    Time frame: During test meal consumption, up to 10 minutes, on test day 2

    Participants will be video-recorded to analyze oral processing behavior of the test meal. Number of bites, chews, swallows and time in mouth (s) will be annotated to derive total eating rate (g per minute).

  12. Oral processing behavior (energy intake rate)

    Time frame: During test meal consumption, up to 10 minutes, on test day 1

    Participants will be video-recorded to analyze oral processing behavior of the test meal. Number of bites, chews, swallows and time in mouth (s) will be annotated to derive total energy intake rate (kcal per minute).

  13. Oral processing behavior (energy intake rate)

    Time frame: During test meal consumption, up to 10 minutes, on test day 2

    Participants will be video-recorded to analyze oral processing behavior of the test meal. Number of bites, chews, swallows and time in mouth (s) will be annotated to derive total energy intake rate (kcal per minute).

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Acronym: GRINCH

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 22, 2023
Registry last updated
Nov 29, 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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