Wolffia Globosa (Mankai) and Glycemic Control Among Patients With Type 2 Diabetes
- Conditions
- Type 2 Diabetes
- Interventions
- Other: Mankai beverageOther: Water (control)
- Registration Number
- NCT04945109
- Lead Sponsor
- Ben-Gurion University of the Negev
- Brief Summary
The investigators primarily aim to explore the effect of daily additive supplementation of Mankai on glucose control among participants with T2D.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- Age => 30 years
- A formal diagnosis of T2D (126mg/dl fasting glucose or higher, or HbA1c=>6.5%) or taking T2D medications.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Mankai beverage first Water (control) Two weeks of Mankai supplementation followed by two weeks of water supplement Mankai beverage first Mankai beverage Two weeks of Mankai supplementation followed by two weeks of water supplement Mankai beverage last Mankai beverage Two weeks of water supplementation followed by two weeks of Mankai supplement Mankai beverage last Water (control) Two weeks of water supplementation followed by two weeks of Mankai supplement
- Primary Outcome Measures
Name Time Method Changes in glycemic control Through study completion, 24hours a day (continuous measurement, all day, 4 weeks) Continuous glucose excursions monitoring
- Secondary Outcome Measures
Name Time Method Insulin 0, 2, 4 weeks Blood measured insulin (mIU/L)
Fasting glucose 0, 2, 4 weeks Blood measure of glucose (mg/dL)
Serum lipids 0, 2, 4 weeks Lipid profile: TC, TG, HDL, LDL
Serum liver Enzymes 0, 2, 4 weeks Liver enzymes: ALT, AST, GGT, ALKP (U/l)
Inflammation 0, 2, 4 weeks hs-CRP
Microbiota profile 0, 2, 4 weeks Fecal bacterial composition and richness
CBC 0, 2, 4 weeks Complete blood cells count: red, white, differential
Abdominal obesity 0, 2, 4 weeks Waist circumference (cm)
Anthropometric 0, 2, 4 weeks Weight (kg), height (cm) to calculate BMI (kg/m\^2)
Blood pressure 0, 2, 4 weeks Systolic and Diastolic blood pressure (mmHg)
Urine markers of glucose 0,2,4 weeks Glucose in urine (mmol/L)
Pulse 0, 2, 4 weeks Resting pulse (beats per minute)
Urine markers of protein 0,2,4 weeks Protein in urine (mg/day)
questionnaire 1 0, 2, 4 weeks Self reports on symptoms during the intervention (yes/no questions)
questionnaire 2 0, 2, 4 weeks Self reports on appetite during the intervention (scale of 0-100%)
questionnaire 3 0, 2, 4 weeks Self reports on satiety during the intervention (scale of 0-100%)
questionnaire 4 0, 2, 4 weeks Self reports on lifestyle (daily log, self report without scale of measurement)
Trial Locations
- Locations (2)
Sheba Medical Centre
🇮🇱Ramat Gan, Israel
Nuclear research center Negev
🇮🇱Dimona, Israel