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A Personalized Diet Study to Reduce Glycemic Exposure

Primary Purpose

Pre-diabetes, Overweight and Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

mHealth

Personalized mHealth

About this trial

This is an interventional treatment trial for Pre-diabetes

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy overweight or obese prediabetic (HbA1c <8.0%)
BMI ≥27 kg/m2
Oral medications with metformin, sulfonylureas, DPP4 inhibitors
Posses smartphone or use study loaner smartphone

Exclusion Criteria:

unable or unwilling to provide informed consent
unable to participate meaningfully in an intervention that involves self-monitoring using software available in English (e.g., due to uncorrected sight impairment, illiterate, non-English-speaking, dementia)
unwilling to accept randomization assignment
women who pregnant, or plan to become pregnant in the next 13 months, or who become pregnant during the study
institutionalized (e.g., in a nursing home or personal care facility, or those who are incarcerated and have limited control over diet)
unwilling to delay bariatric surgery for the next 12 months
diagnosed with heart disease, kidney disease, or retinopathy, (to rule-out those with long-standing T2D)
chronically active inflammatory or neoplastic disease in the past 3 years
diagnosed with a chronic gastrointestinal disorder (e.g. inflammatory bowel disease or celiac disease)
diagnosed with active infection requiring antibiotics in the last 3 months or who develop an active infection requiring antibiotics during the study
taking medications containing acetaminophen and are unwilling or unable to discontinue its use during the study (acetaminophen affects the accuracy of the continuous glucose monitoring [CGM] device)
taking chronic immunosuppressive medications or used them in the 3 months prior to participation, or during the study
managing glycemia with insulin, GLP-I agonists (exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide), insulin secretagogues (Glimepiride, Glipizide, Glyburide, Repaglinide, Nateglinide), or SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin, empagliflozin/metformin, dapagliflozin/metformin)
prescribed medications expected to result in weight loss such as Orlistat, Naltrexone, Bupropion, Lorcaserin, Phentermine, Topiramate, or Liraglutide, and who are unwilling to delay treatment with these medications for the next 12 months
+/- 5% weight change within last month at screening
a eGFR <60 mL/min/1.73m2
younger than 18 or older than 80 years old.

Sites / Locations

New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

mHealth

Personalized mHealth

Arm Description

Outcomes

Primary Outcome Measures

Body weight, percent change

the primary outcome will be relative weight change as a percentage of body weight at baseline and 6-months using calibrated scale.

Secondary Outcome Measures

Body Composition

the secondary outcome will be absolute and relative changes in fat and lean body mass based on bioelectrical impedance analysis (BIA) from baseline to 6-months, 6-months to 12-months and baseline to 12-months

Metabolic Adaptation

the secondary outcome will be the change in resting metabolic rate overall, and in relation to body weight and lean body mass from baseline to 6-months, 6- to 12-months, and baseline to 12-months. Resting metabolic rate will be estimated using indirect calorimetry with the participant in a fasting state (12 hours)

Weight regain

Full Information

NCT ID

NCT03336411

First Posted

November 6, 2017

Last Updated

March 8, 2022

Sponsor

NYU Langone Health

Collaborators

American Heart Association, Weizmann Institute of Science

1. Study Identification

Unique Protocol Identification Number

NCT03336411

Brief Title

A Personalized Diet Study to Reduce Glycemic Exposure

Official Title

Personalized Technology-Supported Counseling to Reduce Glycemic Response in Dietary Weight Loss: The Personal Diet Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

December 12, 2017 (Actual)

Primary Completion Date

April 1, 2021 (Actual)

Study Completion Date

October 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NYU Langone Health

Collaborators

American Heart Association, Weizmann Institute of Science

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of this 2-phase, randomized clinical trial will be to examine the effects of two behavioral weight loss interventions on weight loss. This study will be conducted in 200 overweight or obese prediabetic individuals recruited from community-based settings.. Phase 1 will include 6-months of active intervention. Phase 2 will consist of 6-months of maintenance and observation. Measurements will occur at screening, baseline, 3, 6, and 12 months. Participants will be randomized with equal allocation to 2 groups: (1) a standardized behavioral weight loss intervention with a one-size-fits-all regimen that includes counseling about restriction of calories and calories from fat, and physical activity, delivered using mHealth technology, or (2) all of the elements of mHealth, plus personalized dietary recommendations to minimize glycemic response to meals. Participants will be required to attend 6 separate visits over both phases of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pre-diabetes, Overweight and Obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

269 (Actual)

8. Arms, Groups, and Interventions

Arm Title

mHealth

Arm Type

Active Comparator

Arm Title

Personalized mHealth

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

mHealth

Intervention Description

Behavioral weight loss intervention using behavioral counseling focusing on physical activity and a one-size-fits-all, calorie-restricted, diet.

Intervention Type

Behavioral

Intervention Name(s)

Personalized mHealth

Intervention Description

Behavioral weight loss intervention with personalized dietary recommendations based on machine learning algorithm that integrates gut microbiota, dietary intake, physical activity and various blood parameters to predict postprandial glycemic response.

Primary Outcome Measure Information:

Title

Body weight, percent change

Description

the primary outcome will be relative weight change as a percentage of body weight at baseline and 6-months using calibrated scale.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Body Composition

Description

Time Frame

6 & 12 months

Title

Metabolic Adaptation

Description

Time Frame

6 & 12 months

Title

Weight regain

Time Frame

12 months

Other Pre-specified Outcome Measures:

Title

Glycemic variability (GV )

Description

GV will be obtained from continuous glucose monitoring (CGM) tracings collected with the Abbott FreeStyle Libre Pro.

Time Frame

6 months

Title

RAGE/AGE/S100/A8/A9

Description

In the first 30 participants randomized to the study (15 in each group) having BMI ≥35 kg/m2, at each measurement time point we will examine activation of the RAGE/AGE/S100A8/A9 pathway using measurements of sRAGE, AGE level by ELISA, levels of S100A8/A9 by ELISA, circulating TNF-alpha, IL1-beta, IL4, IL10, and IL-17

Time Frame

6 & 12 MONTHS

Title

Adipokines

Description

Leptin and high molecular weight adiponectin each measurement time point in the subsample of participants having BMI ≥35 kg/m2

Time Frame

6 & 12 months

Title

Self-efficacy

Description

Self-efficacy for weight loss will be assessed using the well-validated Weight Efficacy Lifestyle Questionnaire (WEL)

Time Frame

3,6, 12-months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy overweight or obese prediabetic (HbA1c <8.0%) BMI ≥27 kg/m2 Oral medications with metformin, sulfonylureas, DPP4 inhibitors Posses smartphone or use study loaner smartphone Exclusion Criteria: unable or unwilling to provide informed consent unable to participate meaningfully in an intervention that involves self-monitoring using software available in English (e.g., due to uncorrected sight impairment, illiterate, non-English-speaking, dementia) unwilling to accept randomization assignment women who pregnant, or plan to become pregnant in the next 13 months, or who become pregnant during the study institutionalized (e.g., in a nursing home or personal care facility, or those who are incarcerated and have limited control over diet) unwilling to delay bariatric surgery for the next 12 months diagnosed with heart disease, kidney disease, or retinopathy, (to rule-out those with long-standing T2D) chronically active inflammatory or neoplastic disease in the past 3 years diagnosed with a chronic gastrointestinal disorder (e.g. inflammatory bowel disease or celiac disease) diagnosed with active infection requiring antibiotics in the last 3 months or who develop an active infection requiring antibiotics during the study taking medications containing acetaminophen and are unwilling or unable to discontinue its use during the study (acetaminophen affects the accuracy of the continuous glucose monitoring [CGM] device) taking chronic immunosuppressive medications or used them in the 3 months prior to participation, or during the study managing glycemia with insulin, GLP-I agonists (exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide), insulin secretagogues (Glimepiride, Glipizide, Glyburide, Repaglinide, Nateglinide), or SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin, empagliflozin/metformin, dapagliflozin/metformin) prescribed medications expected to result in weight loss such as Orlistat, Naltrexone, Bupropion, Lorcaserin, Phentermine, Topiramate, or Liraglutide, and who are unwilling to delay treatment with these medications for the next 12 months +/- 5% weight change within last month at screening a eGFR <60 mL/min/1.73m2 younger than 18 or older than 80 years old.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mary Ann Sevick, ScD

Organizational Affiliation

NYU Langone Medical Center, Department of Population Health

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Eran Segal, PhD

Organizational Affiliation

Weizmann Institute of Science, Department of Computer Science and Applied Mathematics

Official's Role

Principal Investigator

Facility Information:

Facility Name

New York University School of Medicine

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

36169954

Citation

Popp CJ, Hu L, Kharmats AY, Curran M, Berube L, Wang C, Pompeii ML, Illiano P, St-Jules DE, Mottern M, Li H, Williams N, Schoenthaler A, Segal E, Godneva A, Thomas D, Bergman M, Schmidt AM, Sevick MA. Effect of a Personalized Diet to Reduce Postprandial Glycemic Response vs a Low-fat Diet on Weight Loss in Adults With Abnormal Glucose Metabolism and Obesity: A Randomized Clinical Trial. JAMA Netw Open. 2022 Sep 1;5(9):e2233760. doi: 10.1001/jamanetworkopen.2022.33760.

Results Reference

derived

PubMed Identifier

35542387

Citation

Popp CJ, Zhou B, Manigrasso MB, Li H, Curran M, Hu L, St-Jules DE, Aleman JO, Vanegas SM, Jay M, Bergman M, Segal E, Sevick MA, Schmidt AM. Soluble Receptor for Advanced Glycation End Products (sRAGE) Isoforms Predict Changes in Resting Energy Expenditure in Adults with Obesity during Weight Loss. Curr Dev Nutr. 2022 Mar 29;6(5):nzac046. doi: 10.1093/cdn/nzac046. eCollection 2022 May.

Results Reference

derived

PubMed Identifier

31669004

Citation

Popp CJ, Butler M, Curran M, Illiano P, Sevick MA, St-Jules DE. Evaluating steady-state resting energy expenditure using indirect calorimetry in adults with overweight and obesity. Clin Nutr. 2020 Jul;39(7):2220-2226. doi: 10.1016/j.clnu.2019.10.002. Epub 2019 Oct 14.

Results Reference

derived

PubMed Identifier

30844471

Citation

Popp CJ, St-Jules DE, Hu L, Ganguzza L, Illiano P, Curran M, Li H, Schoenthaler A, Bergman M, Schmidt AM, Segal E, Godneva A, Sevick MA. The rationale and design of the personal diet study, a randomized clinical trial evaluating a personalized approach to weight loss in individuals with pre-diabetes and early-stage type 2 diabetes. Contemp Clin Trials. 2019 Apr;79:80-88. doi: 10.1016/j.cct.2019.03.001. Epub 2019 Mar 4.

Results Reference

derived

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A Personalized Diet Study to Reduce Glycemic Exposure

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