Ignite Creation Date:
2024-05-06 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03662217
Status:
UNKNOWN
Last Update Posted:
2019-02-07
First Post:
2018-09-02
Brief Title:
Personalized Nutrition for Diabetes Type 2
Sponsor:
DayTwo
Organization:
DayTwo
Study Overview
Official Title:
Personalized Nutrition for Diabetes Type 2
Status:
UNKNOWN
Status Verified Date:
2019-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will investigate the effect of personalized diet on blood glucose control in individuals with diabetes as compared with ADA diet
The primary objective is to test whether personalized diets based on DayTwos algorithm can improve glycemic control and metabolic health compared to standard ADA acceptable dietary approach for diabetes at the end of a 3-month intervention period
The primary objective is to test whether personalized diets based on DayTwos algorithm can improve glycemic control and metabolic health compared to standard ADA acceptable dietary approach for diabetes at the end of a 3-month intervention period
Detailed Description:
The prevalence of diabetes type 2 estimated to 628 Million people in the world by 2045 and was announced by the International Diabetes Federation IDF as one of the biggest epidemics in the history Complications of diabetics Type 2 can range from high blood sugar include heart disease strokes diabetic retinopathy which can result in blindness kidney failure and poor blood flow in the limbs which may lead to amputations 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 postprandial 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 we should build a personally tailored diet which takes into account various factors
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 1000 species with a genetic repertoire of 3 million different genes The microbiome is directly affected by our diet and directly affect the bodys 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
Recently DayTwo developed a highly accurate algorithm for predicting the personalized glucose response to food for each person based on the PNP Study conducted by the Weizmann Institute The algorithms predictions are based on many personal measurements including blood tests personal lifestyle and gut bacteria In a small-scale pilot study that was conducted by the Weizmann Institute using the algorithm the researchers 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 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 diabetes
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 postprandial 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 we should build a personally tailored diet which takes into account various factors
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 1000 species with a genetic repertoire of 3 million different genes The microbiome is directly affected by our diet and directly affect the bodys 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
Recently DayTwo developed a highly accurate algorithm for predicting the personalized glucose response to food for each person based on the PNP Study conducted by the Weizmann Institute The algorithms predictions are based on many personal measurements including blood tests personal lifestyle and gut bacteria In a small-scale pilot study that was conducted by the Weizmann Institute using the algorithm the researchers 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 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 diabetes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None