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Completed

NCT Number: NCT04945109

Wolffia Globosa (Mankai) and Glycemic Control Among Patients With Type 2 Diabetes

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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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nuclear research center Negev, Dimona, Israel

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mankai beverage

Other

Recommended background healthy diet with Mankai supplementation after main meal (300 ml)

Water (control)

Other

Recommended background healthy diet with water supplementation after main meal (300 ml)

Primary outcomes

  1. Changes in glycemic control

    Time frame: Through study completion, 24hours a day (continuous measurement, all day, 4 weeks)

    Continuous glucose excursions monitoring

Secondary outcomes

  1. Insulin

    Time frame: 0, 2, 4 weeks

    Blood measured insulin (mIU/L)

  2. Fasting glucose

    Time frame: 0, 2, 4 weeks

    Blood measure of glucose (mg/dL)

  3. Serum lipids

    Time frame: 0, 2, 4 weeks

    Lipid profile: TC, TG, HDL, LDL

  4. Serum liver Enzymes

    Time frame: 0, 2, 4 weeks

    Liver enzymes: ALT, AST, GGT, ALKP (U/l)

  5. Inflammation

    Time frame: 0, 2, 4 weeks

    hs-CRP

  6. Microbiota profile

    Time frame: 0, 2, 4 weeks

    Fecal bacterial composition and richness

  7. CBC

    Time frame: 0, 2, 4 weeks

    Complete blood cells count: red, white, differential

  8. Anthropometric

    Time frame: 0, 2, 4 weeks

    Weight (kg), height (cm) to calculate BMI (kg/m^2)

  9. Abdominal obesity

    Time frame: 0, 2, 4 weeks

    Waist circumference (cm)

  10. Pulse

    Time frame: 0, 2, 4 weeks

    Resting pulse (beats per minute)

  11. Blood pressure

    Time frame: 0, 2, 4 weeks

    Systolic and Diastolic blood pressure (mmHg)

  12. Urine markers of glucose

    Time frame: 0,2,4 weeks

    Glucose in urine (mmol/L)

  13. Urine markers of protein

    Time frame: 0,2,4 weeks

    Protein in urine (mg/day)

  14. questionnaire 1

    Time frame: 0, 2, 4 weeks

    Self reports on symptoms during the intervention (yes/no questions)

  15. questionnaire 2

    Time frame: 0, 2, 4 weeks

    Self reports on appetite during the intervention (scale of 0-100%)

  16. questionnaire 3

    Time frame: 0, 2, 4 weeks

    Self reports on satiety during the intervention (scale of 0-100%)

  17. questionnaire 4

    Time frame: 0, 2, 4 weeks

    Self reports on lifestyle (daily log, self report without scale of measurement)

Sponsors and collaborators

Lead sponsor

Ben-Gurion University of the Negev

Other

Collaborators

  • Sheba Medical Center

Registry information

Official study title

The Effect of Wolffia Globosa (Mankai) on Glycemic Control Among Patients With Type 2 Diabetes; A Randomized Crossover Controlled Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 30, 2021
Registry last updated
Nov 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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