GLP-1 ConcentrationNCT07096739
Tolerance of a High Protein Nutrition Shake in Individuals on GLP-1
A study testing High protein shake in people with GLP-1 Concentration, run by Kate Farms Inc at 1 site in Canada.
Trial summary
Determine if consuming a high protein nutrition shake reduces gastrointestinal symptoms associated with semaglutide injections. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- GLP-1 Concentration
- What is being tested?
- High protein shake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2025to 19 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Generally healthy individuals aged 18-75 years, inclusive
- BMI >27.0kg/m²
- Taking semaglutide injections (Ozempic or Wegovy) as prescribed (eg. weekly), for at least 4 weeks prior to screening
- Ability to understand the study procedures and willing to provide informed consent to participate in the study
- Subjects must be eligible to receive income in Canada and be covered by a health insurance plan such as OHIP
- Subjects must have an active e-mail address, daily access to an electronic device (e.g. computer, laptop, tablet, smart phone) and internet, and understand how to complete the daily electronic diary daily
Who cannot join
- Failure to meet any one of the inclusion criteria
- Use of a compounded GLP-1 agonist
- Reported history of metabolic (including type 1 and type 2 diabetes mellitus), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, psychiatric disorders, or any other medical conditions that, in the judgment of the Principal Investigator, increase the risk to the subject or others or may affect results
- Hospital admission for major trauma, or major medical or surgical event, as judged by the Principal Investigator, within 6 months of screening
- Use of medications such as, but not limited to, hypoglycemic agents, systemic steroids, antipsychotics, or any others that increase the risk to the subject or others or may affect results, as judged by the Principal Investigator
- Known intolerance, sensitivity, or allergy to any ingredients in the study test products
Show all 9Show fewer
- Self-reported pregnancy or breastfeeding or less than 6 weeks postpartum
- Long term treatment with another investigational drug or other intervention within the last 30 days
- Any condition or diagnosis, that could in the opinion of the Principal Investigator or delegate interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tolerance and Acceptance of a High Protein Nutrition Shake in Individuals Treated With the GLP-1 Receptor Agonist Semaglutide: a Single Arm, Open Label Study
Determine if consuming a high protein nutrition shake reduces gastrointestinal symptoms associated with semaglutide injections.
Read the detailed description
This study investigates the tolerability of a shake specifically designed to reduce GI side effects in individuals being treated with the GLP-1 agonist semaglutide. The study uses a single-arm, open label design where subjects will consume the study product daily for 1 week. Participants will record GI symptoms over the past 24h on 3 days during the week prior to the intervention, and on days 3, 5 and 7 during the intervention
- Conditions
- GLP-1 Concentration
- Being tested
- High protein shake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High protein shakeDietary supplement
Subjects in this study will consume the study product for 1 week. Participants will record GI symptoms over the past 24h on 3 days during the week prior to the intervention, and on days 3, 5, and 7 during the intervention. On the first day, overnight fasted participants will be given the product and symptoms will be followed for 2h. 24h dietary recalls will be collected at the beginning and end of the 7-day treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm | Experimental | Subjects will consume the study product daily for 1 week. Receives: Dietary Supplement: High protein shake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite GI symptoms score (CSS)
Comparison of the composite GI symptom scores (CSS) recorded during the 7day intervention period with those recorded during the 3-day baseline period.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start1 Aug 2025
- Primary completion19 Sep 2025
- Study completion19 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GLP-1 ConcentrationStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kate Farms Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- INQUIS Clinical Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096739
- Sponsor's protocol ID
- INQUIS2025
- Status last verified
- Dec 2025
- First submitted
- 24 Jul 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Withrow NA, Hsueh EE, Wolever T, Jenkins AL, Campbell J, Zurbau A, McMahon R, Valentine CJ. Plant-Based Nutrition Alleviates Gastrointestinal Symptoms and Enhances Protein Intake during GLP-1 Therapy. Curr Dev Nutr. 2026 Jun 8;10(7):109393. doi: 10.1016/j.cdnut.2026.109393. eCollection 2026 Jul.
PubMed 42388893
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance and Acceptance of a High Protein Nutrition Shake in Individuals Treated With the GLP-1 Receptor Agonist Semaglutide: a Single Arm, Open Label Study
- ClinicalTrials.gov ID
- NCT07096739
- Acronym / sponsor ID
- INQUIS2025
- Conditions
- GLP-1 Concentration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Kate Farms IncIndustry (pharma, biotech, devices)
- Collaborators
- INQUIS Clinical Research
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 19 Sep 2025 (actual)
- Study completion
- 19 Sep 2025 (actual)
- First posted
- 31 Jul 2025 (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.
Determine if consuming a high protein nutrition shake reduces gastrointestinal symptoms associated with semaglutide injections.
Detailed description
This study investigates the tolerability of a shake specifically designed to reduce GI side effects in individuals being treated with the GLP-1 agonist semaglutide. The study uses a single-arm, open label design where subjects will consume the study product daily for 1 week. Participants will record GI symptoms over the past 24h on 3 days during the week prior to the intervention, and on days 3, 5 and 7 during the intervention
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm | Experimental | Dietary Supplement: High protein shakeSubjects will consume the study product daily for 1 week. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Generally healthy individuals aged 18-75 years, inclusive
- BMI >27.0kg/m²
- Taking semaglutide injections (Ozempic or Wegovy) as prescribed (eg. weekly), for at least 4 weeks prior to screening
- Ability to understand the study procedures and willing to provide informed consent to participate in the study
- Subjects must be eligible to receive income in Canada and be covered by a health insurance plan such as OHIP
Key exclusion criteria (9 listed)
- Failure to meet any one of the inclusion criteria
- Use of a compounded GLP-1 agonist
- Reported history of metabolic (including type 1 and type 2 diabetes mellitus), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, psychiatric disorders, or any other medical conditions that, in the judgment of the Principal Investigator, increase the risk to the subject or others or may affect results
- Hospital admission for major trauma, or major medical or surgical event, as judged by the Principal Investigator, within 6 months of screening
- Use of medications such as, but not limited to, hypoglycemic agents, systemic steroids, antipsychotics, or any others that increase the risk to the subject or others or may affect results, as judged by the Principal Investigator
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 |
|---|---|---|
| High protein shakeSubjects in this study will consume the study product for 1 week. Participants will record GI symptoms over the past 24h on 3 days during the week prior to the intervention, and on days 3, 5, and 7 during the intervention. On the first day, overnight fasted participants will be given the product and symptoms will be followed for 2h. 24h dietary recalls will be collected at the beginning and end of the 7-day treatment period. | Dietary supplement | Single-arm |
Primary outcome
Composite GI symptoms score (CSS)
Time frame: 7 days
Comparison of the composite GI symptom scores (CSS) recorded during the 7day intervention period with those recorded during the 3-day baseline period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Derived from this study: PubMed 42388893Withrow NA, Hsueh EE, Wolever T, Jenkins AL, Campbell J, Zurbau A, McMahon R, Valentine CJ. Plant-Based Nutrition Alleviates Gastrointestinal Symptoms and Enhances Protein Intake during GLP-1 Therapy. Curr Dev Nutr. 2026 Jun 8;10(7):109393. doi: 10.1016/j.cdnut.2026.109393. eCollection 2026 Jul.
- Individual participant dataSharing planned: No
Related trials for GLP-1 Concentration
Active, not recruiting
Postprandial Glycemic and GLP-1 Responses to Modified Full-sugar Drinks
Postprandial Glucose, GLP-1 Concentration
Active, not recruitingPhase 1/2
Effect of Aqueous Extracts of Cissus Quadrangularis and Dichrostachys Glomerata on GLP-1 Concentration and DPP-4 Activity in Overweight and Obese Adults
Obesity and Overweight, Appetite Regulation
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High protein shake in people with GLP-1 Concentration, run by Kate Farms Inc at 1 site in Canada.
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 6 inclusion and 9 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: finished, as of the sponsor's last update on 9 Dec 2025. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite GI symptoms score (CSS) (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07096739, which also lists 1 linked publication.
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 9 Dec 2025.