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

NCT07446179 | Recruiting

• 1 other identifier: SOLCOMET-263
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glycemic Responses

Keywords

Glycemic response; brewers' spent grain; sustainability; type 2 diabetes; food science

Outcome Measures

Primary Outcomes (1)

• Postrpandial Blood Glucose

  Blood glucose is measured by capillarity.

  From baseline to 120 minutes post-consumption

Other Outcomes (3)

• Weight measures

  Day 1

• Height

  Day 1

• Waist circunference

  Day 1

Study Arms (2)

Biscuit with BSG

EXPERIMENTAL

Other: Food Intervention

Control biscuit

ACTIVE COMPARATOR

Other: Food Intervention

Interventions

Food Intervention OTHER

The participant eats 30g of assigned biscuit

Biscuit with BSG; Control biscuit

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnancy
• Diabetes
• Recent surgerys
• Food allergies

Sponsors & Collaborators

• Universidad Católica del Uruguay: lead

Study Sites (1)

Universidad Católica del Uruguay

Montevideo, 11600, Uruguay

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Maria Belen Gutierrez, PhD

CONTACT

+59898961870; belen.gutierrez@ucu.edu.uy

Sonia Cozzano, PhD

CONTACT

+98141561; scozzano@ucu.edu.uy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: March 3, 2026
• Study Start: March 1, 2026
• Primary Completion: July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

UR (1)