Nutrition+: Effect of a High-Protein Diabetes Formula on... | NCT07271043

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

NCT07271043

Sponsor

Joslin Diabetes Center

Status

Recruiting

Last Update Posted

May 29, 2026Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Type 2 Diabetes

Interventions

protein supplement

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2026Actual

Primary Completion Date

Nov 1, 2026Estimated

Completion Date

Dec 1, 2026Estimated

First Submitted Date

Nov 25, 2025

First Submission Date that Met QC Criteria

Nov 25, 2025

First Posted Date

Dec 8, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2026

Last Update Posted Date

May 29, 2026Actual

Name	Class
Abbott	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Participants will be instructed to drink two HP-DSF shakes	Experimental		Dietary Supplement: protein supplement
Participants in this control group will follow the regular standard of diabetes care	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
protein supplement	Dietary Supplement	HP-DSF shakes provided by Abbott Nutrition	Participants will be instructed to drink two HP-DSF shakes

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject is between 18-75 years of age
Subject was diagnosed with type 2 diabetes at least 3 months prior to screening
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®)
Body mass index (BMI) is ≥ 25 kg/m2

Exclusion Criteria:

Subject has type 1 diabetes mellitus
Subject with estimated glomerular filtration rate <60 milliliters/minute/1.73 m²,
Urine albumin-to-creatinine ratio (UACR) of 300 mg/g or higher
History of acute kidney injury (AKI) during the 6 months prior to screening g.
Intolerance or allergy to HP-DSF shake or to any of its ingredients
Women who are pregnant or lactating or expect to be pregnant or lactating during the study period.
Women of childbearing potential who are not using highly effective contraceptive methods.

-

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Marwa Al-Badri, MD	Contact	6179758258		marwa.albadri@joslin.harvard.edu

Name	Affiliation	Role
Osama Hamdy, MD, PhD	Joslin Diabetes Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Joslin Diabetes Center	Recruiting	Boston	Massachusetts	02215	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases