Tolerance of a High Protein Nutrition Shake in Individuals on GLP-1

NCT07096739 | Completed

• 1 other identifier: INQUIS2025
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Determine if consuming a high protein nutrition shake reduces gastrointestinal symptoms associated with semaglutide injections.

Conditions

GLP-1 Concentration

Outcome Measures

Primary Outcomes (1)

• 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.

  7 days

Study Arms (1)

Single-arm

EXPERIMENTAL

Subjects will consume the study product daily for 1 week.

Dietary Supplement: High protein shake

Interventions

High protein shake DIETARY_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.

Single-arm

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Kate Farms Inc: lead
• INQUIS Clinical Research: collaborator

Study Sites (1)

Inquis Clinical Research

Toronto, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: July 31, 2025
• Study Start: August 1, 2025
• Primary Completion: September 19, 2025
• Study Completion: September 19, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)