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The Effect of Mankai on Glycemic Control Among Patients With T2D - Trial NCT06416475

Access comprehensive clinical trial information for NCT06416475 through Pure Global AI's free database. This Phase 2 trial is sponsored by Ben-Gurion University of the Negev and is currently Recruitment Completed. The study focuses on Diabetes Mellitus, Type 2. Target enrollment is 104 participants.

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NCT06416475
Phase 2
Recruitment Completed
dietary supplement
Trial Details
ClinicalTrials.gov โ€ข NCT06416475
View on ClinicalTrials.gov
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The Effect of Mankai on Glycemic Control Among Patients With T2D
The Effect of Wolffia Globosa (Mankai) on Glycemic Control Among Patients With Type 2 Diabetes; A 3-month Randomized Controlled Pilot Trial

Study Focus

Diabetes Mellitus, Type 2

Mankai supplementation

Interventional

dietary supplement

Sponsor & Location

Ben-Gurion University of the Negev

Be'er Sheva, Israel

Timeline & Enrollment

Phase 2

Apr 30, 2024

Aug 15, 2024

104 participants

Primary Outcome

HbA1c,Fasting glycemic and insulin resistance profiling

Summary

The investigators aim to explore the effect of daily supplementation of Wolfia globosa Mankai
 on HbA1c and insulin resistance response among participants with type 2 diabetes (T2D). The
 investigators hypothesize that adding daily Mankai to T2D's healthy nutrition might lower
 HbA1c and promote glycemic control.
 
 Methods: A 3-month pilot RCT among 104 patients with T2D, with two intervention arms
 consuming comparable bottle volumes of either crude plant Mankai beverage (60ml Mankai) or
 water (60ml) 3 times/day postprandially over 3 months. Blood, urine, fecal, and clinical
 measures will be taken at 0 and 3 months. Overall appetite, food intake, symptoms, and
 medical treatment will be monitored.
 
 Importance: This study's results will shed light on the effects of regular Mankai consumption
 on HbA1c among patients with T2D, which may reveal a new nutritional source to improve
 glycemic control in T2D.

ICD-10 Classifications

Type 2 diabetes mellitus
Type 2 diabetes mellitus with unspecified complications
Type 2 diabetes mellitus with other specified complications
Type 2 diabetes mellitus without complications
Type 2 diabetes mellitus with multiple complications

Data Source

ClinicalTrials.gov

NCT06416475

Non-Device Trial