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Pre DiabetesNCT03222791

Personalized Nutrition for Pre-Diabetes

A study testing Algorithm-based diet and Mediterranean-style low-fat diet in people with Pre Diabetes, run by Weizmann Institute of Science at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Pre Diabetes
What is being tested?
Algorithm-based diet and Mediterranean-style low-fat diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
244 participants
Where
1 siteIsrael
Study dates
1 Feb 2017to 1 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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
Show all 11Show fewer
  • Psychiatric disorders
  • Coagulation disorders
  • IBD (inflammatory bowel diseases)
  • Bariatric surgery
  • Alcohol or substance abuse

Trial locations and contacts

1 site in 1 country.

Israel1 site
  • The Weizmann Institute of Science

    Rehovot

Other trials in Israel

About this study

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.

Read the 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.

Conditions
Pre Diabetes
Being tested
Algorithm-based diet, Mediterranean-style low-fat diet
Keywords
Diabetes
Medical subject headings
Glucose Intolerance, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • Mediterranean-style low-fat dietOther

    The Israeli standard of care dietary guidelines for prediabetes.

Study groups in NCT03222791
Study groupRoleWhat they receive
Algorithm-based dietExperimentalSubjects randomized to this arm will receive personally tailored dietary recommendations based on their predicted glycemic responses according to the study algorithm.
Receives: Other: Algorithm-based diet
Mediterranean-style low-fat dietOtherSubjects randomized to this arm will receive nutritional recommendations according to the standard Israeli dietary approach for treating pre-diabetes: Mediterranean-style low-fat diet.
Receives: Other: Mediterranean-style low-fat diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 6 months

  2. 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

    Measured: 6 months

  3. Mean change in Glucose Tolerance Test from the baseline level

    GTT glucose values (mg/dl)

    Measured: 6 months

Secondary outcomes (2)
  1. Change is Fasting plasma glucose from baseline

    Fasting glucose values (mg/dl)

    Measured: 6 months

  2. Change in HOMA-IR from baseline

    Change in insulin sensitivity from baseline to 6 months will be measured via HOMA-IR

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2017
  2. Study start1 Feb 2017
  3. Primary completion10 Sep 2019
  4. Study completion1 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
244 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03222791
Sponsor's protocol ID
20170117
Status last verified
Apr 2020
First submitted
13 Jul 2017
Last updated
22 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 37137684
  • 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.

    PubMed 34301736

Questions about this trial

What is this clinical trial studying?

A study testing Algorithm-based diet and Mediterranean-style low-fat diet in people with Pre Diabetes, run by Weizmann Institute of Science at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of the total daily time of plasma glucose levels below 140 mg/dl (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03222791, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2020.

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