A Personalized Diet Study to Reduce Glycemic Exposure

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

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.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity; Pre-diabetes
• Intervention / Treatment: Behavioral: Personalized mHealth; Behavioral: mHealth

• Study Type: Interventional
• Enrollment (Actual): 269
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: mHealth	Behavioral: Personalized mHealth; 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.
Experimental: Personalized mHealth	Behavioral: mHealth; Behavioral weight loss intervention using behavioral counseling focusing on physical activity and a one-size-fits-all, calorie-restricted, diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 & 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)	6 & 12 months
Weight regain		12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic variability (GV )	GV will be obtained from continuous glucose monitoring (CGM) tracings collected with the Abbott FreeStyle Libre Pro.	6 months
RAGE/AGE/S100/A8/A9	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	6 & 12 MONTHS
Adipokines	Leptin and high molecular weight adiponectin each measurement time point in the subsample of participants having BMI ≥35 kg/m2	6 & 12 months
Self-efficacy	Self-efficacy for weight loss will be assessed using the well-validated Weight Efficacy Lifestyle Questionnaire (WEL)	3,6, 12-months

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: Weizmann Institute of Science; American Heart Association
• Investigators: Principal Investigator: Mary Ann Sevick, ScD, NYU Langone Medical Center, Department of Population Health; Principal Investigator: Eran Segal, PhD, Weizmann Institute of Science, Department of Computer Science and Applied Mathematics

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2017
• Primary Completion (Actual): April 1, 2021
• Study Completion (Actual): October 27, 2021

Study Registration Dates

• First Submitted: November 6, 2017
• First Submitted That Met QC Criteria: November 6, 2017
• First Posted (Actual): November 8, 2017

Study Record Updates

• Last Update Posted (Actual): March 10, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Body Weight; Prediabetic State; Overweight
• Other Study ID Numbers: 17-00741

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No