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

The Effect of Wolffia Globosa (Mankai) on Glycemic Control Among Patients With Type 2 Diabetes; A Randomized Crossover Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: Mankai beverage; Other: Water (control)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Dimona, Israel
    • nuclear research center Negev
  • Ramat Gan, Israel
    • Sheba Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mankai beverage first; Two weeks of Mankai supplementation followed by two weeks of water supplement	Other: Mankai beverage; Recommended background healthy diet with Mankai supplementation after main meal (300 ml); Other: Water (control); Recommended background healthy diet with water supplementation after main meal (300 ml)
Experimental: Mankai beverage last; Two weeks of water supplementation followed by two weeks of Mankai supplement	Other: Mankai beverage; Recommended background healthy diet with Mankai supplementation after main meal (300 ml); Other: Water (control); Recommended background healthy diet with water supplementation after main meal (300 ml)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in glycemic control	Continuous glucose excursions monitoring	Through study completion, 24hours a day (continuous measurement, all day, 4 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin	Blood measured insulin (mIU/L)	0, 2, 4 weeks
Fasting glucose	Blood measure of glucose (mg/dL)	0, 2, 4 weeks
Serum lipids	Lipid profile: TC, TG, HDL, LDL	0, 2, 4 weeks
Serum liver Enzymes	Liver enzymes: ALT, AST, GGT, ALKP (U/l)	0, 2, 4 weeks
Inflammation	hs-CRP	0, 2, 4 weeks
Microbiota profile	Fecal bacterial composition and richness	0, 2, 4 weeks
CBC	Complete blood cells count: red, white, differential	0, 2, 4 weeks
Anthropometric	Weight (kg), height (cm) to calculate BMI (kg/m^2)	0, 2, 4 weeks
Abdominal obesity	Waist circumference (cm)	0, 2, 4 weeks
Pulse	Resting pulse (beats per minute)	0, 2, 4 weeks
Blood pressure	Systolic and Diastolic blood pressure (mmHg)	0, 2, 4 weeks
Urine markers of glucose	Glucose in urine (mmol/L)	0,2,4 weeks
Urine markers of protein	Protein in urine (mg/day)	0,2,4 weeks
questionnaire 1	Self reports on symptoms during the intervention (yes/no questions)	0, 2, 4 weeks
questionnaire 2	Self reports on appetite during the intervention (scale of 0-100%)	0, 2, 4 weeks
questionnaire 3	Self reports on satiety during the intervention (scale of 0-100%)	0, 2, 4 weeks
questionnaire 4	Self reports on lifestyle (daily log, self report without scale of measurement)	0, 2, 4 weeks

Collaborators and Investigators

• Sponsor: Ben-Gurion University of the Negev
• Collaborators: Sheba Medical Center, Israel
• Investigators: Principal Investigator: amir Tirosh, MD PhD, Sheba Medical Center

Publications and helpful links

General Publications

• 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, Bluher 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2021
• Primary Completion (Actual): November 18, 2021
• Study Completion (Actual): November 18, 2021

Study Registration Dates

• First Submitted: June 14, 2021
• First Submitted That Met QC Criteria: June 25, 2021
• First Posted (Actual): June 30, 2021

Study Record Updates

• Last Update Posted (Actual): November 30, 2021
• Last Update Submitted That Met QC Criteria: November 28, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 0094-21SOR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No