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

Kate Farms

Status: Completed

Conditions: GLP-1 Concentration

Treatments: Dietary Supplement: High protein shake

Study type: Interventional

Funder types: Industry

Identifiers

NCT07096739

INQUIS2025

Details and patient eligibility

About

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

Full 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

Enrollment: 20 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Exclusion criteria

1. Failure to meet any one of the inclusion criteria
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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Single-arm

Experimental group

Description:

Subjects will consume the study product daily for 1 week.

Treatment:

Dietary Supplement: High protein shake