Type 2 Diabetes
Conditions
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.
Interventions
OTHERMankai beverage
Recommended background healthy diet with Mankai supplementation after main meal (300 ml)
OTHERWater (control)
Recommended background healthy diet with water supplementation after main meal (300 ml)
Sponsors
Sheba Medical Center
Ben-Gurion University of the Negev
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in glycemic control | Through study completion, 24hours a day (continuous measurement, all day, 4 weeks) | Continuous glucose excursions monitoring |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Anthropometric | 0, 2, 4 weeks | Weight (kg), height (cm) to calculate BMI (kg/m\^2) |
| Abdominal obesity | 0, 2, 4 weeks | Waist circumference (cm) |
| Insulin | 0, 2, 4 weeks | Blood measured insulin (mIU/L) |
| 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) |
| 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) |
| Pulse | 0, 2, 4 weeks | Resting pulse (beats per minute) |
Countries
Israel
Outcome results
None listed