NCT04945109

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable type-2-diabetes

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 30, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

October 19, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2021

Completed
Last Updated

November 30, 2021

Status Verified

November 1, 2021

Enrollment Period

1 month

First QC Date

June 14, 2021

Last Update Submit

November 28, 2021

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Changes in glycemic control

    Continuous glucose excursions monitoring

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

Secondary Outcomes (17)

  • Insulin

    0, 2, 4 weeks

  • Fasting glucose

    0, 2, 4 weeks

  • Serum lipids

    0, 2, 4 weeks

  • Serum liver Enzymes

    0, 2, 4 weeks

  • Inflammation

    0, 2, 4 weeks

  • +12 more secondary outcomes

Study Arms (2)

Mankai beverage first

EXPERIMENTAL

Two weeks of Mankai supplementation followed by two weeks of water supplement

Other: Mankai beverageOther: Water (control)

Mankai beverage last

EXPERIMENTAL

Two weeks of water supplementation followed by two weeks of Mankai supplement

Other: Mankai beverageOther: Water (control)

Interventions

Mankai beverageOTHER

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

Mankai beverage firstMankai beverage last
Water (control)OTHER

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

Mankai beverage firstMankai beverage last

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nuclear research center Negev

Dimona, Israel

Location

Sheba Medical Centre

Ramat Gan, Israel

Location

Related Publications (1)

  • 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.

    PMID: 31076421BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Water

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Amir Tirosh, MD PhD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Iris Shai

Study Record Dates

First Submitted

June 14, 2021

First Posted

June 30, 2021

Study Start

October 19, 2021

Primary Completion

November 18, 2021

Study Completion

November 18, 2021

Last Updated

November 30, 2021

Record last verified: 2021-11

Locations

IL(2)