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Type 2 DiabetesNCT04945109

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

A study testing Mankai beverage in people with Type 2 Diabetes, run by Ben-Gurion University of the Negev at 2 sites in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigators primarily aim to explore the effect of daily additive supplementation of Mankai on glucose control among participants with T2D. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Type 2 Diabetes
What is being tested?
Mankai beverage
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
2 sitesIsrael
Study dates
19 Oct 2021to 18 Nov 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age => 30 years
  • A formal diagnosis of T2D (126mg/dl fasting glucose or higher, or HbA1c=>6.5%) or taking T2D medications.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Israel2 sites

  • Nuclear research center Negev

    Dimona

  • Sheba Medical Centre

    Ramat Gan

Other trials in Israel

About this study

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

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

Read the 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.

Conditions
Type 2 Diabetes
Being tested
Mankai beverage, Water (control)
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mankai beverageOther

    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)

Study groups in NCT04945109
Study groupRoleWhat they receive
Mankai beverage firstExperimentalTwo weeks of Mankai supplementation followed by two weeks of water supplement
Receives: Other: Mankai beverage; Other: Water (control)
Mankai beverage lastExperimentalTwo weeks of water supplementation followed by two weeks of Mankai supplement
Receives: Other: Mankai beverage; Other: Water (control)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in glycemic control

    Continuous glucose excursions monitoring

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

Secondary outcomes (17)

  1. Insulin

    Blood measured insulin (mIU/L)

    Measured: 0, 2, 4 weeks

  2. Fasting glucose

    Blood measure of glucose (mg/dL)

    Measured: 0, 2, 4 weeks

  3. Serum lipids

    Lipid profile: TC, TG, HDL, LDL

    Measured: 0, 2, 4 weeks

  4. Serum liver Enzymes

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

    Measured: 0, 2, 4 weeks

  5. Inflammation

    hs-CRP

    Measured: 0, 2, 4 weeks

  6. Microbiota profile

    Fecal bacterial composition and richness

    Measured: 0, 2, 4 weeks

  7. CBC

    Complete blood cells count: red, white, differential

    Measured: 0, 2, 4 weeks

  8. Anthropometric

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

    Measured: 0, 2, 4 weeks

  9. Abdominal obesity

    Waist circumference (cm)

    Measured: 0, 2, 4 weeks

  10. Pulse

    Resting pulse (beats per minute)

    Measured: 0, 2, 4 weeks

  11. Blood pressure

    Systolic and Diastolic blood pressure (mmHg)

    Measured: 0, 2, 4 weeks

  12. Urine markers of glucose

    Glucose in urine (mmol/L)

    Measured: 0,2,4 weeks

  13. Urine markers of protein

    Protein in urine (mg/day)

    Measured: 0,2,4 weeks

  14. questionnaire 1

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

    Measured: 0, 2, 4 weeks

  15. questionnaire 2

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

    Measured: 0, 2, 4 weeks

  16. questionnaire 3

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

    Measured: 0, 2, 4 weeks

  17. questionnaire 4

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

    Measured: 0, 2, 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2021
  2. Study start19 Oct 2021
  3. Primary completion18 Nov 2021
  4. Study completion18 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
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 blind
Who is masked
Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04945109
Sponsor's protocol ID
0094-21SOR
Status last verified
Nov 2021
First submitted
14 Jun 2021
Last updated
30 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 31076421

  • Tsaban G, Aharon-Hananel G, Shalem S, Zelicha H, Yaskolka Meir A, Pachter D, Goldberg DT, Kamer O, Alufer L, Stampfer MJ, Wang DD, Qi L, Bluher M, Stumvoll M, Hu FB, Shai I, Tirosh A. The effect of Mankai plant consumption on postprandial glycaemic response among patients with type 2 diabetes: A randomized crossover trial. Diabetes Obes Metab. 2024 Oct;26(10):4713-4723. doi: 10.1111/dom.15840. Epub 2024 Aug 12.

    PubMed 39134456

Questions about this trial

What is this clinical trial studying?

A study testing Mankai beverage in people with Type 2 Diabetes, run by Ben-Gurion University of the Negev at 2 sites in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in glycemic control (time frame: Through study completion, 24hours a day (continuous measurement, all day, 4 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04945109, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2021.

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