Glycemic ResponsesBSG-PPGNCT07446179
Blood Glucose Response to Test Foods Containing Brewer's Spent Grain
A study testing Food Intervention in people with Glycemic Responses, run by Universidad Católica del Uruguay at 1 site in Uruguay.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycemic Responses
- What is being tested?
- Food Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUruguay
- Study dates
- 1 Mar 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) between 18.5 and 30 kg/m².
Who cannot join
- Pregnancy
- Diabetes
- Recent surgerys
- Food allergies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Uruguay1 site, 1 recruiting
- Recruiting
Universidad Católica del Uruguay
Montevideo, 11600
Maria Belen Gutierrez, PhD, +59898961870, belen.gutierrez@ucu.edu.uy
Sonia Cozzano, PhD, +59898141561, scozzano@ucu.edu.uy
About this study
Official title: 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.
Read more
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
- Being tested
- Food Intervention
- Keywords
- Glycemic response, brewers' spent grain, sustainability, type 2 diabetes, food science
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food InterventionOther
The participant eats 30g of assigned biscuit
| Study group | Role | What they receive |
|---|---|---|
| Biscuit with BSG | Experimental | Not described Receives: Other: Food Intervention |
| Control biscuit | Active comparator | Not described Receives: Other: Food Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postrpandial Blood Glucose
Blood glucose is measured by capillarity.
Measured: From baseline to 120 minutes post-consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start1 Mar 2026
- Primary completionJul 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycemic ResponsesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Católica del Uruguay
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446179
- Sponsor's protocol ID
- SOLCOMET-263
- Acronym
- BSG-PPG
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brewer's Spent Grain a Potential Ally for the Prevention of Type II Diabetes: Determination of Blood Glucose Absorption of New Foods
- ClinicalTrials.gov ID
- NCT07446179
- Acronym / sponsor ID
- BSG-PPG / SOLCOMET-263
- Conditions
- Glycemic Responses
- Keywords
- Glycemic response, brewers' spent grain, sustainability, type 2 diabetes, food science
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universidad Católica del UruguayUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biscuit with BSG | Experimental | Other: Food Intervention |
| Control biscuit | Active comparator | Other: Food Intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Body mass index (BMI) between 18.5 and 30 kg/m².
Key exclusion criteria (4 listed)
- Pregnancy
- Diabetes
- Recent surgerys
- Food allergies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food InterventionThe participant eats 30g of assigned biscuit | Other | Biscuit with BSG, Control biscuit |
Primary outcome
Postrpandial Blood Glucose
Time frame: From baseline to 120 minutes post-consumption
Blood glucose is measured by capillarity.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food Intervention in people with Glycemic Responses, run by Universidad Católica del Uruguay at 1 site in Uruguay.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uruguay. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Belen Gutierrez, PhD (+59898961870, belen.gutierrez@ucu.edu.uy), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postrpandial Blood Glucose (time frame: From baseline to 120 minutes post-consumption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.