Clinical trial NCT04945109: Wolffia Globosa (Mankai) and Glycemic Control Among Patients With Type 2 Diabetes
Official title: The Effect of Wolffia Globosa (Mankai) on Glycemic Control Among Patients With Type 2 Diabetes; A Randomized Crossover Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Ben-Gurion University of the Negev
Sponsor class: OTHER
Collaborators: name: Sheba Medical Center
First posted: 2021-06-30
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in glycemic control
timeFrame: Through study completion, 24hours a day (continuous measurement, all day, 4 weeks)
Secondary outcomes:
measure: Insulin
timeFrame: 0, 2, 4 weeks
measure: Fasting glucose
timeFrame: 0, 2, 4 weeks
measure: Serum lipids
timeFrame: 0, 2, 4 weeks
measure: Serum liver Enzymes
timeFrame: 0, 2, 4 weeks
measure: Inflammation
timeFrame: 0, 2, 4 weeks
measure: Microbiota profile
timeFrame: 0, 2, 4 weeks
measure: CBC
timeFrame: 0, 2, 4 weeks
measure: Anthropometric
timeFrame: 0, 2, 4 weeks
measure: Abdominal obesity
timeFrame: 0, 2, 4 weeks
measure: Pulse
timeFrame: 0, 2, 4 weeks
measure: Blood pressure
timeFrame: 0, 2, 4 weeks
measure: Urine markers of glucose
timeFrame: 0,2,4 weeks
measure: Urine markers of protein
timeFrame: 0,2,4 weeks
measure: questionnaire 1
timeFrame: 0, 2, 4 weeks
measure: questionnaire 2
timeFrame: 0, 2, 4 weeks
measure: questionnaire 3
timeFrame: 0, 2, 4 weeks
measure: questionnaire 4
timeFrame: 0, 2, 4 weeks
Other outcomes:
Locations:
city: Dimona
country: Israel
facility: Nuclear research center Negev
city: Ramat Gan
country: Israel
facility: Sheba Medical Centre
Study officials:
affiliation: Sheba Medical Center
name: Amir Tirosh, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.