Mankai beverage
OtherRecommended background healthy diet with Mankai supplementation after main meal (300 ml)
NCT Number: NCT04945109
The investigators primarily aim to explore the effect of daily additive supplementation of Mankai on glucose control among participants with T2D.
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Notify Me30 year and older
All sexes
Interventional
Not applicable
Nuclear research center Negev, Dimona, Israel
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Recommended background healthy diet with Mankai supplementation after main meal (300 ml)
Recommended background healthy diet with water supplementation after main meal (300 ml)
Time frame: Through study completion, 24hours a day (continuous measurement, all day, 4 weeks)
Continuous glucose excursions monitoring
Time frame: 0, 2, 4 weeks
Blood measured insulin (mIU/L)
Time frame: 0, 2, 4 weeks
Blood measure of glucose (mg/dL)
Time frame: 0, 2, 4 weeks
Lipid profile: TC, TG, HDL, LDL
Time frame: 0, 2, 4 weeks
Liver enzymes: ALT, AST, GGT, ALKP (U/l)
Time frame: 0, 2, 4 weeks
hs-CRP
Time frame: 0, 2, 4 weeks
Fecal bacterial composition and richness
Time frame: 0, 2, 4 weeks
Complete blood cells count: red, white, differential
Time frame: 0, 2, 4 weeks
Weight (kg), height (cm) to calculate BMI (kg/m^2)
Time frame: 0, 2, 4 weeks
Waist circumference (cm)
Time frame: 0, 2, 4 weeks
Resting pulse (beats per minute)
Time frame: 0, 2, 4 weeks
Systolic and Diastolic blood pressure (mmHg)
Time frame: 0,2,4 weeks
Glucose in urine (mmol/L)
Time frame: 0,2,4 weeks
Protein in urine (mg/day)
Time frame: 0, 2, 4 weeks
Self reports on symptoms during the intervention (yes/no questions)
Time frame: 0, 2, 4 weeks
Self reports on appetite during the intervention (scale of 0-100%)
Time frame: 0, 2, 4 weeks
Self reports on satiety during the intervention (scale of 0-100%)
Time frame: 0, 2, 4 weeks
Self reports on lifestyle (daily log, self report without scale of measurement)
Ben-Gurion University of the Negev
Other
The Effect of Wolffia Globosa (Mankai) on Glycemic Control Among Patients With Type 2 Diabetes; A Randomized Crossover Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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