Blood Glucose Response to Test Foods Containing Brewer's Spent Grain

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversidad Católica del Uruguay

About this trial

The objective of this project is to determine the impact of incorporating brewers' spent grain into cookie formulations on postprandial blood glucose absorption levels following consumption. The methodology for assessing blood glucose response to cookies formulated with brewers' spent grain is described as follows.

A total of 20 participants will be recruited from the Universidad Católica del Uruguay. Volunteers will be recruited through institutional email dissemination, with Dr. María Belén Gutiérrez serving as the research contact.

Eligible participants will be healthy adults without diagnosed diseases and not taking regular medication. Inclusion criteria will be: men and women aged 18 to 75 years and a body mass index (BMI) between 18.5 and 30 kg/m². Exclusion criteria will include: pregnancy, diabetes, special dietary regimens, recent surgeries, and hypersensitivity or allergy to any of the components of the tested foods.

A physical assessment will be performed for each participant, including waist and hip circumferences, body weight, and height. Each participant will be assigned a volunteer identification code, and the data analyst will be blinded to the identity of the participants. Volunteers may withdraw from the study at any time without any consequences.

Participants will be studied on four separate occasions (one session per week). On two occasions they will receive 30 g of a commercial María cookie, and on the other two occasions 30 g of a reduced-sugar cookie containing 17% extruded brewers' spent grain. During the study period, participants will be asked to maintain their usual lifestyle.

Participants will attend the University Clinic in the morning after an 8-10 hour overnight fast. After a fasting blood sample is obtained, the corresponding treatment will be provided, and participants will have 15 minutes to consume it. Capillary blood samples will be collected at 15, 30, 45, 60, 90, and 120 minutes after the start of treatment consumption.

Blood sampling will be performed via capillary puncture using a commercially available glucometer, with disposable lancets used for each measurement and safely discarded after each sample. Sample collection will be carried out by trained personnel from the Department of Health and Well-being of the Universidad Católica del Uruguay.

During the testing period, participants will be allowed to drink up to 250 mL of water and must remain seated. For each participant and each treatment day, a data collection sheet will be used to record all measurements. After each experimental session, participants will receive a breakfast voucher.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Body mass index (BMI) between 18.5 and 30 kg/m².

Disqualifiers

Pregnancy

Diabetes

Recent surgerys

Food allergies

Trial design

Design model

Crossover

Treatments tested in this trial

  • Food Intervention

    Other intervention

    The participant eats 30g of assigned biscuit

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Biscuit with BSGExperimental treatment 1 intervention
Group B: Control biscuitActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Postrpandial Blood Glucose

Blood glucose is measured by capillarity.

Time frame
From baseline to 120 minutes post-consumption

Secondary outcomes

Other outcomes

1

Weight measures

Weight

Time frame
Day 1
2

Height

Volunteers height

Time frame
Day 1
3

Waist circunference

Volunteers' waist circunference

Time frame
Day 1

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