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| Name | Class |
|---|---|
| Sheba Medical Center | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mankai beverage first | Experimental | Two weeks of Mankai supplementation followed by two weeks of water supplement |
|
| Mankai beverage last | Experimental | Two weeks of water supplementation followed by two weeks of Mankai supplement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mankai beverage | Other | Recommended background healthy diet with Mankai supplementation after main meal (300 ml) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in glycemic control | Continuous glucose excursions monitoring | Through study completion, 24hours a day (continuous measurement, all day, 4 weeks) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amir Tirosh, MD PhD | Sheba Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nuclear research center Negev | Dimona | Israel | ||||
| Sheba Medical Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31076421 | Background | 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. | |
| 39134456 |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D014867 | Water |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 |
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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.
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| Water (control) | Other | Recommended background healthy diet with water supplementation after main meal (300 ml) |
|
| 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 |
| Ramat Gan |
| Israel |
| Derived |
| Tsaban G, Aharon-Hananel G, Shalem S, Zelicha H, Yaskolka Meir A, Pachter D, Goldberg DT, Kamer O, Alufer L, Stampfer MJ, Wang DD, Qi L, Bluher M, Stumvoll M, Hu FB, Shai I, Tirosh A. The effect of Mankai plant consumption on postprandial glycaemic response among patients with type 2 diabetes: A randomized crossover trial. Diabetes Obes Metab. 2024 Oct;26(10):4713-4723. doi: 10.1111/dom.15840. Epub 2024 Aug 12. |
| D004700 | Endocrine System Diseases |
| Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |