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NCT05294861: Milk-GM
Effect of Milk Consumption on Glycemia and Gut Microbiome in T2D
NA trial testing YesMdiet in Type2Diabetes in 20 participants. Status unknown.
28 October 2022
Quick facts
| Lead sponsor | Tel Aviv University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 28 April 2022 |
| Primary completion | 28 October 2022 |
| Estimated completion | 28 December 2022 |
Drugs / interventions tested
- YesMdiet
- NoMdiet
Conditions studied
- Type2Diabetes — all drugs for Type2Diabetes →
Sponsor
Tel Aviv University
Who can join
Adults 30 to 75, any sex, with Type2Diabetes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05294861
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05294861 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tel Aviv University
- Last refreshed: 24 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05294861.
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