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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Joslin Diabetes Center
Study ID
NCT07271043
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • protein supplement — DIETARY_SUPPLEMENT
    HP-DSF shakes provided by Abbott Nutrition

Study Details

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.

Key Dates

Start date
Jan 1, 2026
Status verified
May 2026
Primary completion
Nov 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Participants will be instructed to drink two HP-DSF shakes
  • No Intervention: Participants in this control group will follow the regular standard of diabetes care

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Joslin Diabetes CenterBostonMassachusetts02215
Marwa Al-Badri, MD
6179758258
Osama Hamdy, MD., PhD (PRINCIPAL_INVESTIGATOR)
Adham Mottalib, MD (SUB_INVESTIGATOR)

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