An interventional study of YesMdiet and NoMdiet in Type2Diabetes, sponsored by Tel Aviv University. Status unknown. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-03-24.
Sponsored by Tel Aviv University · Not applicable, Interventional, and Treatment
The overall glycemic excursions display circadian variations which are controlled by the circadian clock genes (CCG) and are strongly influenced by meal timing.
Indeed, in T2D, a diet aligned with the CCG, with high-energy and protein breakfast, and reduced in CH dinner (Bdiet) resulted in effective reduction of body weight, HbA1c, and of overall glycemia versus reverse schedule or six meals, with energy and carbohydrates (CH) evenly distributed throughout the day.
in addition to meal timing of Bdiet, the source of protein i.e., Milk and dairy products, by favorable changes in the Guts Microbiome (GM) composition may also play a role in the reduction of overall glycemia of T2D.
The investigators hypothesize that Bdiet schedule with high content of milk and other dairy proteins (YesMdiet), will reduce overall glycemia in T2D, compared to isocaloric and iso-protein Bdiet with another source (nondairy) proteins (NoMdiet).
Study Design: The effect of the two Bdiet interventions on GM will be assessed in T2D participants in a cross-over design, at baseline and after YesMdiet and after NoMdiet, in random order. We expect more favorable changes in glycemic control and in GM composition in YesMdiet versus NoMdiet.
Background: Reduction of the overall glycemic excursion is the main target in the treatment of T2D to reduce HbA1c and cardiovascular risk. The overall glycemic excursions display circadian variations controlled by the circadian clock genes (CG) and are strongly influenced by meal timing.
Indeed, the investigators have recently shown in T2D, that a diet aligned with the CCG, with high-energy and protein breakfast, and reduced in CH dinner (Bdiet) resulted in effective reduction of body weight, HbA1c, and substantial reduction of overall (diurnal and nocturnal) glycemia as compared to the reverse schedule or a diet with six meals, with energy and carbohydrates (CH) evenly distributed throughout the day.
However, in addition to meal timing, the source of protein in Bdiet and the changes of Gut Microbiome (GM) composition, may also play a role in the reduction of overall glycemia. It has been recently shown that consumption of milk and dairy products is associated beneficial effect on overall glycemia. Further, milk and dairy may exert a beneficial effect on overall glycemia by favorable changes in GM composition.
Working hypothesis: Therefore, in this study, we hypothesize that a Bdiet schedule with high content of milk and other dairy proteins (YesMdiet), compared to isocaloric and iso-protein Bdiet with another source (nondairy) proteins (NoMdiet) and may lead to favorable changes in the Gut Microbiota (GM) [Primary end-point] in association with the improvement of overall glycemia in T2D participant under continuous glucose monitoring (CGM) surveillance.
Study Design: The effect of the two Bdiet interventions on GM will be assessed in n=16 participants in a cross-over design, at baseline and after 14 days of Bdiet consuming Milk and dairy products (YesMdiet) or isocaloric Bdiet without milk or dairy products (NoMdiet), in random order in T2D individual undergoing CGM surveillance.
Expected results: We expect more favorable changes in glycemic control and in GM composition in YesMdiet versus NoMdiet.
Scientific Significance: This trial will reveal whether the benefits of Bdiet on glycemic control is further enhanced by milk and dairy consumption, in association with favorable changes in Gut Microbiome
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's planned enrollment of 20 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Tel Aviv University is the lead sponsor of 100 studies on the registry; 26 are open to participants now.
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Exclusion Criteria:
After one week baseline, the participants will be assigned to YesMdiet, consuming milk and dairy products for 14 days
Other: YesMdiet
After one week baseline, the participants will be assigned to NoMdiet, consuming another source of protein and without milk or dairy products for 14 days
Other: NoMdiet
In the YesMdiet, participants will consume Milk and Dairy products
Also known as: Yes Milk diet
In the YesMdiet, participants will not consume Milk and Dairy products, only other sources of protein
Also known as: No Milk diet
Gut Microbiome
Gut Microbiome composition will be assessed using 16s rRNA sequencing method after 14 days of YesMdiet
Time frame: 14 day
Gut Microbiome
Gut Microbiome composition will be assessed using 16s rRNA sequencing method after 14 days of NoMdiet
Time frame: 14 days
Overall Glycemia
Overall Glycemia will be assessed using continuous glucose monitoring CGM during 14 days of either YesMdiet or NoBdiet
Time frame: 14 days
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Tel Aviv University