Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Personalized Nutrition for Pre-Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03222791
Recruitment Status : Recruiting
First Posted : July 19, 2017
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Weizmann Institute of Science

Tracking Information
First Submitted Date  ICMJE July 13, 2017
First Posted Date  ICMJE July 19, 2017
Last Update Posted Date November 17, 2017
Actual Study Start Date  ICMJE February 1, 2017
Estimated Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2017)
  • Evaluation of the total daily time of plasma glucose levels below 140 mg/dl [ Time Frame: 6 months ]
    Total daily plasma glucose levels will be evaluated by using a Continuous glucose monitoring (CGM)
  • Mean change in HbA1C from the baseline level [ Time Frame: 6 months ]
    Difference of at least 0.1% in the reduction of HbA1C between control group and experimental group
  • Mean change in Glucose Tolerance Test from the baseline level [ Time Frame: 6 months ]
    GTT glucose values (mg/dl)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03222791 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2017)
  • Change is Fasting plasma glucose from baseline [ Time Frame: 6 months ]
    Fasting glucose values (mg/dl)
  • Change in HOMA-IR from baseline [ Time Frame: 6 months ]
    Change in insulin sensitivity from baseline to 6 months will be measured via HOMA-IR
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 18, 2017)
Patients compliance evaluation using a compliance questionnaire [ Time Frame: 6 months, 12 months ]
Follow up questionnaire completed independently by the patients
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Personalized Nutrition for Pre-Diabetes
Official Title  ICMJE Personalized Nutrition for Pre-Diabetes
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.
Detailed Description

Blood glucose levels are rapidly increasing in the population, as evident by the sharp incline in the prevalence of prediabetes and impaired glucose tolerance estimated to affect, in the U.S. alone, 37% of the adult population. Chronic hyperglycaemia is a significant risk factor for type II diabetes mellitus (TIIDM), with up to 70% of prediabetics eventually developing the disease. It is also linked to other manifestations, collectively termed the metabolic syndrome, including obesity, hypertension, non-alcoholic fatty liver disease, hypertriglyceridemia and cardiovascular disease.

As blood glucose levels are mainly affected by food consumption, the growing number of blood glucose abnormalities is likely attributable to nutrition. Indeed, dietary and lifestyle changes normalize blood glucose levels in 55% -80% of the cases. Therefore, maintaining normal blood glucose levels is critical for preventing diabetes and its metabolic complications.

Currently, there are no effective methods for predicting the post prandial glycemic response (PPGR) of people to food. The current practice of using the meal carbohydrate content is a poor predictor of the PPGR and has limited efficacy.The glycemic index (GI), which quantifies PPGR to consumption of a single tested food type, and the derived glycemic load have limited applicability in assessing the PPGR to real-life meals consisting of arbitrary food combinations and varying quantities, consumed at different times of the day, and at different proximity to physical activity and other meals. Indeed, studies examining the effect of diets with a low glycemic index on TIIDM risk, weight loss, and cardiovascular risk factors yielded mixed results. The limited success of GI measure is probably due to the fact that it is a general index, which does not take into consideration the large variation between individuals in their glycemic response to food. It can be concluded, therefore, that in order to control glycemic response of an individual, a personalized tailored diet which takes into account various factors is required. Although genetic factors influence the levels of fasting blood glucose and glycemic response to food, these factors only explain approximately 10% of the variance in the population. Supporting this claim is the fact that the number of people with diabetes is increasing in recent years regardless of patients' genetic background. In contrast, environmental factors such as the composition of the intestinal bacteria and their metabolic activity may affect the glycemic response. The entire bacteria population in the digestive tract (microbiome) consist of ~1,000 species with a genetic repertoire of ~3 million different genes. The microbiome is directly affected by our diet and directly affect the body's response to food. This special relationship between the host and the intestinal flora is reflected by the composition of bacteria unique to type 2 diabetes and in the significant changes in the bacteria composition upon transition from a diet rich in fiber to a "Western" diet rich in simple sugars.

The study is conducted to evaluate a highly accurate algorithm developed at the Weizmann Institute of Science for predicting the personalized glucose response to food for each person. The algorithm‟s predictions are based on many personal measurements, including blood tests, personal lifestyle and gut bacteria. In a small-scale pilot study that was conducted using this algorithm, the investigators personally tailored dietary interventions to healthy and prediabetic people, which resulted in significantly improved PPGRs accompanied by consistent alterations to the gut microbiota. These findings led the investigators to hypothesize that tailoring personalized diets based on PPGRs predictions may achieve better outcomes in terms of controlling blood glucose levels and its metabolic consequences relative to the current standard nutritional therapy for prediabetes.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Pre Diabetes
Intervention  ICMJE
  • Other: Algorithm-based diet
    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.
  • Other: Mediterranean-style low-fat diet
    The Israeli standard of care dietary guidelines for prediabetes.
Study Arms  ICMJE
  • Experimental: Algorithm-based diet
    Subjects randomized to this arm will receive personally tailored dietary recommendations based on their predicted glycemic responses according to the study algorithm.
    Intervention: Other: Algorithm-based diet
  • Mediterranean-style low-fat diet
    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.
    Intervention: Other: Mediterranean-style low-fat diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 18, 2017)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2018
Estimated Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Orly Ben-Yacov +972-8-9344307 orlyby@weizmann.ac.il
Contact: Michal Rein +972-8-9344307 michal.rein@weizmann.ac.il
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03222791
Other Study ID Numbers  ICMJE 20170117
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Weizmann Institute of Science
Study Sponsor  ICMJE Weizmann Institute of Science
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eran Segal, Prof. Weizmann Institute of Science
Principal Investigator: Eran Elinav, MD Weizmann Institute of Science
PRS Account Weizmann Institute of Science
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP