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Dietary Management

Sponsor:

NYU Langone Health

Code:

NCT05046886

Conditions

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Standardized

Usual Care Control (UCC)

Personalized Guidance to Minimize Postprandial Glycemic Response (PPGR)

Study Details

Brief summary:

In a randomized trial of 255 participants with early-stage T2D, participants will be randomized to 1 of 3 groups: Standardized, Personalized, or a Usual Care Control (UCC). In the first phase, participants will be randomized with equal allocation to these 3 groups. In the second phase (current phase), the remaining participants will be randomized with equal allocation to the Standardized and UCC groups.

Conditions

Type 2 Diabetes

Study ID

NCT05046886

Start date

Dec 14, 2021

Status verified date

Feb, 2025

Completion date

Nov 30, 2025

Anticipated

Primary completion date

Nov 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • must be an adult 21-80 years of age
  • must be diagnosed with early-stage T2D defined as HbA1c<8% and managed for the past 3 months on a diabetes regimen that included lifestyle plus metformin.
  • those who are willing and able to use a smart phone to self monitor their diet and to attend WebEx sessions

Exclusion Criteria:

  • those who have conditions or treatments likely to alter the underlying function of the microbiome, an insulin response that is driven by factors other than glycemic response to food, conditions/treatments that make it difficult to isolate the true nature of the relationship between randomization assignment and weight loss, characteristics or preferences that would preclude meaningful participation in the study
  • those who are unable or unwilling to adhere to an intervention that requires dietary self-monitoring
  • those who have been prescribed: (1) antibiotics or antifungals in the past 3 months, (2) diabetic medications other than metformin, (3) weight loss medications, (4) chronic use of steroids or immunosuppressants, (5) atypical antipsychotics, and (6) chemotherapy.
  • those who are pregnant, planning to become pregnant during the study period, or become pregnant during the study
  • those who have a chronic disease that affects energy/glucose metabolism (e.g., Cushing's syndrome, acromegaly, hyperthyroidism)
  • those who require special dietary management (end-stage kidney disease, cirrhosis, HIV)
  • those who are unable or unwilling to provide informed consent
  • those who are unable to participate meaningfully in an intervention that involves self-monitoring using software available in English (e.g., uncorrected sight impairment, illiterate, non-English-speaking, dementia)
  • those who are unwilling to accept randomization assignment
  • those who have limited control over diet (e.g., are homeless or institutionalized, in a nursing home or personal care facility, or incarcerated)
  • those who have previously had bariatric surgery, or are unwilling to delay bariatric surgery for the next 7 months
  • those who are unable to walk without a walker or cane for 2 city blocks
  • those who have been diagnosed with a chronic active inflammatory or neoplastic disease in the past 3 years
  • those who have been diagnosed with a chronic gastrointestinal disorder (e.g., inflammatory bowel disease or celiac disease)
  • those who have an active substance use disorder

Study Design

Enrollment

255 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Usual Care Control (UCC)

Baseline advice about the Mediterranean-style diet and attention control.

active comparator: Standardized

One-size-fits-all dietary counseling to follow a Mediterranean-style diet

active comparator: Personalized

Dietary counseling to follow a Mediterranean-style diet personalized to reduce postprandial glycemic response

Interventions

Standardized

Participants are instructed to follow a Mediterranean-style diet. Dietary counseling is paired with SCT-based behavioral counseling, which focuses on the role played by self-referent thought in the maintenance of behavior change. Self-efficacy (e.g., the participant's confidence in their ability to engage in healthier behavior) is derived from four major sources of information: mastery experiences, social modeling, verbal persuasion, and physiological states. Participants self-monitor their diet using a mobile app and receive real-time feedback from the app on macronutrient distribution.

Usual Care Control (UCC)

Participants are instructed to follow a Mediterranean-style diet,

Personalized Guidance to Minimize Postprandial Glycemic Response (PPGR)

Participants are instructed to follow a Mediterranean-style diet. Dietary counseling is paired with SCT-based behavioral counseling, which focuses on the role played by self-referent thought in the maintenance of behavior change. Self-efficacy (e.g., the participant's confidence in their ability to engage in healthier behavior) is derived from four major sources of information: mastery experiences, social modeling, verbal persuasion, and physiological states. Participants self-monitor their diet using a mobile app and receive real-time feedback from the app on their predicted PPGR to meals and snacks at the time they enter them into their smart phone. PPGR predictions will be generated from a gut microbiome-based machine learning algorithm.

Primary outcome measure

  • Mean Amplitude of Glycemic Excursion (MAGE) [ Time Frame: Month 3 ]
  • Mean Amplitude of Glycemic Excursion (MAGE) [ Time Frame: Month 6 ]

Central Contacts and Locations

Central contacts

Margaret Curran

646-501-3459Margaret.curran@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Margaret Curran

Margaret.curran@nyulangone.org

Principal Investigator:

Mary Sevick, ScD

More Information

Sponsor

NYU Langone Health

Last update posted

Feb 24, 2025

Last verified

Feb, 2025

Keywords

  • precision nutrition
  • Mediterranean diet
  • behavioral intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2025-02-24.