NCT03222791

Brief Summary

The Personalized Nutrition Project for Prediabetes (PNP3) study will investigate whether personalized diet intervention will improve postprandial blood glucose levels and other metabolic health factors in individuals with prediabetes as compared with the standard low-fat diet.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
244

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 19, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

April 22, 2020

Status Verified

April 1, 2020

Enrollment Period

2.6 years

First QC Date

July 13, 2017

Last Update Submit

April 21, 2020

Conditions

Pre Diabetes

Keywords

Diabetes

Outcome Measures

Primary Outcomes (3)

  • Evaluation of the total daily time of plasma glucose levels below 140 mg/dl

    Total daily plasma glucose levels will be evaluated by using a Continuous glucose monitoring (CGM)

    6 months

  • Mean change in HbA1C from the baseline level

    Difference of at least 0.1% in the reduction of HbA1C between control group and experimental group

    6 months

  • Mean change in Glucose Tolerance Test from the baseline level

    GTT glucose values (mg/dl)

    6 months

Secondary Outcomes (2)

  • Change is Fasting plasma glucose from baseline

    6 months

  • Change in HOMA-IR from baseline

    6 months

Other Outcomes (1)

  • Patients compliance evaluation using a compliance questionnaire

    6 months, 12 months

Study Arms (2)

Algorithm-based diet

EXPERIMENTAL

Subjects randomized to this arm will receive personally tailored dietary recommendations based on their predicted glycemic responses according to the study algorithm.

Other: Algorithm-based diet

Mediterranean-style low-fat diet

OTHER

Subjects randomized to this arm will receive nutritional recommendations according to the standard Israeli dietary approach for treating pre-diabetes: Mediterranean-style low-fat diet.

Other: Mediterranean-style low-fat diet

Interventions

Algorithm-based dietOTHER

Personalized nutrition plan based on an algorithm for predicting the personalized glucose response to food. The algorithm's predictions are based on many personal measurements, including blood tests, personal lifestyle and gut bacteria.

Algorithm-based diet
Mediterranean-style low-fat dietOTHER

The Israeli standard of care dietary guidelines for prediabetes.

Mediterranean-style low-fat diet

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • HbA1C 5.7 - 6.4
  • Fasting Glucose 100 - 125 mg/dl
  • Age - 18-55
  • Capable of working with smartphone application

You may not qualify if:

  • Antibiotics/antifungal in the last 3 month
  • Use of anti-diabetic and/or weight-loss medication
  • People under another diet regime and/or a dietitian consultation/another study
  • Pregnancy, fertility treatments
  • Chronic disease (e.g. HIV, Cushing syndrome, CKD, acromegaly, hyperthyroidism etc.)
  • Cancer and recent anticancer treatment
  • Psychiatric disorders
  • Coagulation disorders
  • IBD (inflammatory bowel diseases)
  • Bariatric surgery
  • Alcohol or substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Weizmann Institute of Science

Rehovot, Israel

Location

Related Publications (2)

  • Ben-Yacov O, Godneva A, Rein M, Shilo S, Lotan-Pompan M, Weinberger A, Segal E. Gut microbiome modulates the effects of a personalised postprandial-targeting (PPT) diet on cardiometabolic markers: a diet intervention in pre-diabetes. Gut. 2023 Aug;72(8):1486-1496. doi: 10.1136/gutjnl-2022-329201. Epub 2023 May 3.

    PMID: 37137684DERIVED

  • Ben-Yacov O, Godneva A, Rein M, Shilo S, Kolobkov D, Koren N, Cohen Dolev N, Travinsky Shmul T, Wolf BC, Kosower N, Sagiv K, Lotan-Pompan M, Zmora N, Weinberger A, Elinav E, Segal E. Personalized Postprandial Glucose Response-Targeting Diet Versus Mediterranean Diet for Glycemic Control in Prediabetes. Diabetes Care. 2021 Sep;44(9):1980-1991. doi: 10.2337/dc21-0162. Epub 2021 Jul 23.

    PMID: 34301736DERIVED

MeSH Terms

Conditions

Glucose IntoleranceDiabetes Mellitus

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Eran Segal, Prof.

    Weizmann Institute of Science

    PRINCIPAL INVESTIGATOR

  • Eran Elinav, MD

    Weizmann Institute of Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2017

First Posted

July 19, 2017

Study Start

February 1, 2017

Primary Completion

September 10, 2019

Study Completion

March 1, 2020

Last Updated

April 22, 2020

Record last verified: 2020-04

Locations

IL(1)