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

NCT ID: NCT04945109

Last Updated: 2021-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-19

Study Completion Date

2021-11-18

Brief Summary

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

Detailed Description

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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

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Mankai beverage first

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

Group Type EXPERIMENTAL

Mankai beverage

Intervention Type OTHER

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

Water (control)

Intervention Type OTHER

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

Mankai beverage last

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

Group Type EXPERIMENTAL

Mankai beverage

Intervention Type OTHER

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

Water (control)

Intervention Type OTHER

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

Interventions

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Mankai beverage

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

Intervention Type OTHER

Water (control)

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role collaborator

Ben-Gurion University of the Negev

OTHER

Sponsor Role lead

Responsible Party

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Iris Shai

Prof. Iris Shai

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amir Tirosh, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

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Nuclear research center Negev

Dimona, , Israel

Site Status

Sheba Medical Centre

Ramat Gan, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type BACKGROUND
PMID: 31076421 (View on PubMed)

Other Identifiers

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0094-21SOR

Identifier Type: -

Identifier Source: org_study_id