Nutrition+: Effect of a High-Protein Diabetes Formula on Body Composition in Type 2 Diabetes Patients Treated With Incretin Mimetics

May 27, 2026 updated by: Joslin Diabetes Center

Evaluating the Efficacy of High-Protein Diabetes Specific Formula (HP-DSF) on Body Composition in Overweight/Obese Patients With Type 2 Diabetes Treated With Incretin Mimetic Drugs

A randomized clinical study to assess the efficacy of a high-protein diabetes specific formula (HPDSF) on lean muscle mass in overweight and obese patients with type 2 diabetes who are initiating treatment with incretin-mimetic drugs.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Joslin Diabetes Center
        • Contact:
        • Principal Investigator:
          • Osama Hamdy, MD., PhD
        • Sub-Investigator:
          • Adham Mottalib, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subject is between 18-75 years of age
  2. Subject was diagnosed with type 2 diabetes at least 3 months prior to screening
  3. Subject is about to start treatment with an IMD, a GLP-1 receptor agonist (RA) alone or a dual GLP-1/GIP RA. These treatments include either semaglutide (Ozempic®, Wegovy®), tirzepatide (Mounjaro®, Zepbound®), or dulaglutide (Trulicity®)
  4. Body mass index (BMI) is ≥ 25 kg/m2

Exclusion Criteria:

  1. Subject has type 1 diabetes mellitus
  2. Subject with estimated glomerular filtration rate <60 milliliters/minute/1.73 m²,
  3. Urine albumin-to-creatinine ratio (UACR) of 300 mg/g or higher
  4. History of acute kidney injury (AKI) during the 6 months prior to screening g.
  5. Intolerance or allergy to HP-DSF shake or to any of its ingredients
  6. Women who are pregnant or lactating or expect to be pregnant or lactating during the study period.

  7. Women of childbearing potential who are not using highly effective contraceptive methods.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Participants in this control group will follow the regular standard of diabetes care
Experimental: Participants will be instructed to drink two HP-DSF shakes
Dietary supplement: protein supplement
HP-DSF shakes provided by Abbott Nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in lean muscle mass from baseline
Time Frame: Endpoints will be analyzed at three months and six months.
Endpoints will be analyzed at three months and six months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joslin Diabetes Center

Collaborators

Abbott

Investigators

  • Principal Investigator: Osama Hamdy, MD, PhD, Joslin Diabetes Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 25, 2025

First Submitted That Met QC Criteria

November 25, 2025

First Posted (Actual)

December 8, 2025

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000322

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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