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Completed

NCT Number: NCT03336411

A Personalized Diet Study to Reduce Glycemic Exposure

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mHealth

Behavioral

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

Personalized mHealth

Behavioral

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 outcomes

  1. Body weight, percent change

    Time frame: 6 months

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

Secondary outcomes

  1. Body Composition

    Time frame: 6 & 12 months

    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

  2. Metabolic Adaptation

    Time frame: 6 & 12 months

    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)

  3. Weight regain

    Time frame: 12 months

Other outcomes

  1. Glycemic variability (GV )

    Time frame: 6 months

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

  2. RAGE/AGE/S100/A8/A9

    Time frame: 6 & 12 MONTHS

    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

  3. Adipokines

    Time frame: 6 & 12 months

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

  4. Self-efficacy

    Time frame: 3,6, 12-months

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

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • American Heart Association
  • Weizmann Institute of Science

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Nov 8, 2017
Registry last updated
Mar 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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