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

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

Detailed Description
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Other: Mankai beverage
* Other: Water (control)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: A randomized cross-over, 4-week trial, where participants will be allocated to start with or without daily Mankai supplementation (fresh Mankai beverage) added on top of a standardized diabetes-related healthy diet, each for two weeks. The investigators will follow postprandial and overnight glycemic response using ﬂash glucose monitoring system device. Other outcomes include clinical parameters (weight, waist circumference, blood pressure), blood, urine, fecal measurements, overall appetite/ satiety, food intake consumption, symptoms, and medical treatment.
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |