Type 2 Diabetes Clinical Trial
Official title:
The Effect of Wolffia Globosa (Mankai) on Glycemic Control Among Patients With Type 2 Diabetes; A Randomized Crossover Controlled Trial
Verified date | November 2021 |
Source | Ben-Gurion University of the Negev |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators primarily aim to explore the effect of daily additive supplementation of Mankai on glucose control among participants with T2D.
Status | Completed |
Enrollment | 50 |
Est. completion date | November 18, 2021 |
Est. primary completion date | November 18, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years and older |
Eligibility | Inclusion Criteria: - Age => 30 years - A formal diagnosis of T2D (126mg/dl fasting glucose or higher, or HbA1c=>6.5%) or taking T2D medications. Exclusion Criteria: - Treatment with coumadin (warfarin) - Advanced renal failure - A significant illness that might require hospitalization - State of pregnancy or lactation - Presence of active cancer or chemotherapy treatment in last three years - Participation in another trial. |
Country | Name | City | State |
---|---|---|---|
Israel | Nuclear research center Negev | Dimona | |
Israel | Sheba Medical Centre | Ramat Gan |
Lead Sponsor | Collaborator |
---|---|
Ben-Gurion University of the Negev | Sheba Medical Center, Israel |
Israel,
Zelicha H, Kaplan A, Yaskolka Meir A, Tsaban G, Rinott E, Shelef I, Tirosh A, Brikner D, Pupkin E, Qi L, Thiery J, Stumvoll M, Kloting N, von Bergen M, Ceglarek U, Blüher M, Stampfer MJ, Shai I. The Effect of Wolffia globosa Mankai, a Green Aquatic Plant, on Postprandial Glycemic Response: A Randomized Crossover Controlled Trial. Diabetes Care. 2019 Jul;42(7):1162-1169. doi: 10.2337/dc18-2319. Epub 2019 May 10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in glycemic control | Continuous glucose excursions monitoring | Through study completion, 24hours a day (continuous measurement, all day, 4 weeks) | |
Secondary | Insulin | Blood measured insulin (mIU/L) | 0, 2, 4 weeks | |
Secondary | Fasting glucose | Blood measure of glucose (mg/dL) | 0, 2, 4 weeks | |
Secondary | Serum lipids | Lipid profile: TC, TG, HDL, LDL | 0, 2, 4 weeks | |
Secondary | Serum liver Enzymes | Liver enzymes: ALT, AST, GGT, ALKP (U/l) | 0, 2, 4 weeks | |
Secondary | Inflammation | hs-CRP | 0, 2, 4 weeks | |
Secondary | Microbiota profile | Fecal bacterial composition and richness | 0, 2, 4 weeks | |
Secondary | CBC | Complete blood cells count: red, white, differential | 0, 2, 4 weeks | |
Secondary | Anthropometric | Weight (kg), height (cm) to calculate BMI (kg/m^2) | 0, 2, 4 weeks | |
Secondary | Abdominal obesity | Waist circumference (cm) | 0, 2, 4 weeks | |
Secondary | Pulse | Resting pulse (beats per minute) | 0, 2, 4 weeks | |
Secondary | Blood pressure | Systolic and Diastolic blood pressure (mmHg) | 0, 2, 4 weeks | |
Secondary | Urine markers of glucose | Glucose in urine (mmol/L) | 0,2,4 weeks | |
Secondary | Urine markers of protein | Protein in urine (mg/day) | 0,2,4 weeks | |
Secondary | questionnaire 1 | Self reports on symptoms during the intervention (yes/no questions) | 0, 2, 4 weeks | |
Secondary | questionnaire 2 | Self reports on appetite during the intervention (scale of 0-100%) | 0, 2, 4 weeks | |
Secondary | questionnaire 3 | Self reports on satiety during the intervention (scale of 0-100%) | 0, 2, 4 weeks | |
Secondary | questionnaire 4 | Self reports on lifestyle (daily log, self report without scale of measurement) | 0, 2, 4 weeks |
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