A Personalized Diet Study to Reduce Glycemic Exposure

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03336411
• Other study ID #: 17-00741
• Status: Completed
• Phase: N/A
• Start date: December 12, 2017
• Est. completion date: October 27, 2021

Study information

• Verified date: March 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 269
• Est. completion date: October 27, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity
• Pre-diabetes
• Prediabetic State

Intervention

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

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
NYU Langone Health	American Heart Association, Weizmann Institute of Science

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Glycemic variability (GV )	GV will be obtained from continuous glucose monitoring (CGM) tracings collected with the Abbott FreeStyle Libre Pro.	6 months
Other	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
Other	Adipokines	Leptin and high molecular weight adiponectin each measurement time point in the subsample of participants having BMI =35 kg/m2	6 & 12 months
Other	Self-efficacy	Self-efficacy for weight loss will be assessed using the well-validated Weight Efficacy Lifestyle Questionnaire (WEL)	3,6, 12-months
Primary	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	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
Secondary	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
Secondary	Weight regain		12 months