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

NCT ID: NCT07096739

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2025-09-19

Brief Summary

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

Conditions

GLP-1 Concentration

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Single-arm

Subjects will consume the study product daily for 1 week.

Group Type: EXPERIMENTAL

High protein shake

Intervention Type: 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.

Interventions

High protein shake

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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

2. Use of a compounded GLP-1 agonist

3. 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

4. Hospital admission for major trauma, or major medical or surgical event, as judged by the Principal Investigator, within 6 months of screening

5. 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

6. Known intolerance, sensitivity, or allergy to any ingredients in the study test products

7. Self-reported pregnancy or breastfeeding or less than 6 weeks postpartum

8. Long term treatment with another investigational drug or other intervention within the last 30 days

9. 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

INQUIS Clinical Research

INDUSTRY

Sponsor Role: collaborator

Kate Farms Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Inquis Clinical Research

Toronto, , Canada

Countries

Canada

Other Identifiers

INQUIS2025

Identifier Type: -

Identifier Source: org_study_id