Wolffia Globosa (Mankai) and Glycemic Control Among Patients With Type 2 Diabetes

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04945109
• Other study ID #: 0094-21SOR
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

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