The Effect of Wolffia Globosa (Mankai) on Glycemic Control Among Patients With Type 2 Diabetes; A Randomized Crossover Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Changes in glycemic control
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Mankai beverage first
Two weeks of Mankai supplementation followed by two weeks of water supplement
Intervention: Mankai beverage (Other)
Mankai beverage first
Two weeks of Mankai supplementation followed by two weeks of water supplement
Intervention: Water (control) (Other)
Mankai beverage last
Two weeks of water supplementation followed by two weeks of Mankai supplement
Intervention: Mankai beverage (Other)
Mankai beverage last
Two weeks of water supplementation followed by two weeks of Mankai supplement
Intervention: Water (control) (Other)
Outcomes
Primary Outcomes
Changes in glycemic control
Time Frame: Through study completion, 24hours a day (continuous measurement, all day, 4 weeks)
Continuous glucose excursions monitoring
Secondary Outcomes
- Pulse(0, 2, 4 weeks)
- Insulin(0, 2, 4 weeks)
- Fasting glucose(0, 2, 4 weeks)
- Serum lipids(0, 2, 4 weeks)
- Serum liver Enzymes(0, 2, 4 weeks)
- Inflammation(0, 2, 4 weeks)
- Microbiota profile(0, 2, 4 weeks)
- CBC(0, 2, 4 weeks)
- Abdominal obesity(0, 2, 4 weeks)
- Anthropometric(0, 2, 4 weeks)
- Blood pressure(0, 2, 4 weeks)
- Urine markers of glucose(0,2,4 weeks)
- Urine markers of protein(0,2,4 weeks)
- questionnaire 1(0, 2, 4 weeks)
- questionnaire 2(0, 2, 4 weeks)
- questionnaire 3(0, 2, 4 weeks)
- questionnaire 4(0, 2, 4 weeks)
Investigators
Iris Shai
Prof. Iris Shai
Ben-Gurion University of the Negev