Blood Glucose Response to Test Foods Containing Brewer's Spent Grain (BSG-PPG)

Brewer's Spent Grain a Potential Ally for the Prevention of Type II Diabetes: Determination of Blood Glucose Absorption of New Foods

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Glycemic Responses
• Intervention / Treatment: Other: Food Intervention

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Belen Gutierrez, PhD; Phone Number: +59898961870; Email: belen.gutierrez@ucu.edu.uy
• Study Contact Backup: Name: Sonia Cozzano, PhD; Phone Number: +98141561; Email: scozzano@ucu.edu.uy

Study Locations

• Uruguay
  • Montevideo, Uruguay, 11600
    • Universidad Católica del Uruguay
    • Contact: Maria Belen Gutierrez, PhD; Phone Number: +59898961870; Email: belen.gutierrez@ucu.edu.uy
    • Contact: Sonia Cozzano, PhD; Phone Number: +59898141561; Email: scozzano@ucu.edu.uy
    • Principal Investigator: Maria Belen Gutierrez, PhD
    • Sub-Investigator: Sonia Cozzano, PhD
    • Sub-Investigator: Valentina Lestido, PhD
    • Sub-Investigator: Verónica Olivera, BSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnancy
• Diabetes
• Recent surgerys
• Food allergies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biscuit with BSG	Other: Food Intervention; The participant eats 30g of assigned biscuit
Active Comparator: Control biscuit	Other: Food Intervention; The participant eats 30g of assigned biscuit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postrpandial Blood Glucose	Blood glucose is measured by capillarity.	From baseline to 120 minutes post-consumption

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight measures	Weight	Day 1
Height	Volunteers height	Day 1
Waist circunference	Volunteers' waist circunference	Day 1

Collaborators and Investigators

• Sponsor: Universidad Católica del Uruguay

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 19, 2026
• First Submitted That Met QC Criteria: February 25, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: type 2 diabetes; Glycemic response; sustainability; brewers' spent grain; food science
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: SOLCOMET-263

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be publicly shared. De-identified data may be available from the principal investigator upon reasonable request and subject to ethical approval and institutional regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No