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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04945109
Other study ID # 0094-21SOR
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 19, 2021
Est. completion date November 18, 2021

Study information

Verified date November 2021
Source Ben-Gurion University of the Negev
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators primarily aim to explore the effect of daily additive supplementation of Mankai on glucose control among participants with T2D.


Description:

Type 2 diabetes is a major public health concern in Western societies. Type 2 diabetes is associated with high morbidity and shorter life expectancy. In patients with type 2 diabetes maintaining glycemic control is associated with lower rates of complications and mortality associated with the disease. Thus, there is a great need to recognize nutritional elements that improve glycemic control and insulin sensitivity in patients with type 2 diabetes. Mankai, a strain of Wolffia globosa recently developed under controlled conditions, is characterized by high protein content and good bioavailability of proteins, rich in soluble fiber, vitamins (including vitamin B12), minerals (including iron and zinc), omega 3 fatty acids, and polyphenols. The 18-month long DIRECT PLUS trial was a weight-loss intervention conducted among 294 participants with abdominal obesity or dyslipidemia. 98 of the study participants were assigned to the intervention of a green Mediterranean diet and were instructed to consume four frozen cubes of Mankai daily. Main conclusions from the DIRECT PLUS refer to the beneficial effect of the green-Mediterranean diet on cardiometabolic risk, gut bacteria, and liver fat, with no evidence of disadvantages or adverse effects of long-term Mankai consumption. In 2019, the investigators reported that among non-diabetics and those with fasting glucose levels within the normal range, consuming a Mankai smoothie in the evening led to lower glucose levels after the meal and lower fasting overnight compared to a yogurt smoothie. The investigators now plan to explore the effect of Mankai daily supplementation on post-meal glycemic response in participants with type 2 diabetes. The investigators hypothesize that the addition of Mankai consumption after a meal may mitigate glucose excursions compared with control.


Recruitment information / eligibility

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.

Study Design


Intervention

Other:
Mankai beverage
Recommended background healthy diet with Mankai supplementation after main meal (300 ml)
Water (control)
Recommended background healthy diet with water supplementation after main meal (300 ml)

Locations

Country Name City State
Israel Nuclear research center Negev Dimona
Israel Sheba Medical Centre Ramat Gan

Sponsors (2)

Lead Sponsor Collaborator
Ben-Gurion University of the Negev Sheba Medical Center, Israel

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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

Outcome

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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