Understanding Acute Dietary Changes After GLP-1 Agonist Treatment: The GLaD Feasibility Study

Recruiting

• Conditions: Obesity; Type 2 Diabetes Mellitus (T2DM)

• Registration Number: NCT07001553
• Lead Sponsor: Australian Catholic University

Brief Summary

An observational study of those who have been prescribed a GLP-1 agonist therapy (yet to commence), for either weight or diabetes management, and are willing to complete dietary records and questionnaires of behaviour and psychosocial health.

Detailed Description

Forty individuals (20 for weight management, 20 for diabetes management) living in Australia who have been prescribed a GLP-1 agonist (no previous prescription or no use in the previous 6 months) will be recruited to participate over the initial 3 months of their treatment. Assessments will occur remotely (online) at baseline, 2 weeks, 1 month and 3 months. Optional body composition assessments will be provided at baseline and 3 months for those based in Melbourne, Australia.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-22
• Study Start: 2025-05-28
• Study First Submitted QC: 2025-06-01
• Study First Posted: 2025-06-03
• Last Update Submitted: 2025-07-06
• Last Update Posted: 2025-07-10
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Aged 18+ years old
• Intending to commence a prescription for a GLP-1 agonist (may be dual agonist, i.e. Ozempic, Trulicity, Monjaro, or Saxenda) medication, with no use in the previous 6 months
• The primary reason for commencing the medication will be for diabetes or weight management
• Willing to participate in dietary recall and questionnaires

Exclusion Criteria

• Aged under 18 years,
• used a GLP-1 agonist medication in the previous 6 months,
• unwilling or unable to provide dietary recalls
• non-English speaking.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of recruitment	4 months	The rate of recruitment and the retention rate of participants completing the dietary assessment measures.

Secondary Outcome Measures

Name	Time	Method
Energy intake	baseline, 2 weeks, 1 month, 3 months	Assessed using Intake24 records for at least 2 days per timepoint
Medication symptomology	baseline, 1 month, 3 months	Incidence of self-reported side effects
Medication use	baseline, 1 month, 3 months	Dosage

Trial Locations

Locations (1)

Australian Catholic University; 🇦🇺 Fitzroy, Victoria, Australia