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Trial record 3 of 3 for:    Wolffia Globosa

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04945109
Recruitment Status : Completed
First Posted : June 30, 2021
Last Update Posted : November 30, 2021
Sponsor:
Collaborator:
Sheba Medical Center, Israel
Information provided by (Responsible Party):
Iris Shai, Ben-Gurion University of the Negev

Brief Summary:
The investigators primarily aim to explore the effect of daily additive supplementation of Mankai on glucose control among participants with T2D.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Other: Mankai beverage Other: Water (control) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Wolffia Globosa (Mankai) on Glycemic Control Among Patients With Type 2 Diabetes; A Randomized Crossover Controlled Trial
Actual Study Start Date : October 19, 2021
Actual Primary Completion Date : November 18, 2021
Actual Study Completion Date : November 18, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mankai beverage first
Two weeks of Mankai supplementation followed by two weeks of water supplement
Other: Mankai beverage
Recommended background healthy diet with Mankai supplementation after main meal (300 ml)

Other: Water (control)
Recommended background healthy diet with water supplementation after main meal (300 ml)

Experimental: Mankai beverage last
Two weeks of water supplementation followed by two weeks of Mankai supplement
Other: Mankai beverage
Recommended background healthy diet with Mankai supplementation after main meal (300 ml)

Other: Water (control)
Recommended background healthy diet with water supplementation after main meal (300 ml)




Primary Outcome Measures :
  1. Changes in glycemic control [ Time Frame: Through study completion, 24hours a day (continuous measurement, all day, 4 weeks) ]
    Continuous glucose excursions monitoring


Secondary Outcome Measures :
  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)



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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04945109


Locations
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Israel
Nuclear research center Negev
Dimona, Israel
Sheba Medical Centre
Ramat Gan, Israel
Sponsors and Collaborators
Ben-Gurion University of the Negev
Sheba Medical Center, Israel
Investigators
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Principal Investigator: Amir Tirosh, MD PhD Sheba Medical Center
Publications:
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Responsible Party: Iris Shai, Prof. Iris Shai, Ben-Gurion University of the Negev
ClinicalTrials.gov Identifier: NCT04945109    
Other Study ID Numbers: 0094-21SOR
First Posted: June 30, 2021    Key Record Dates
Last Update Posted: November 30, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases