Clinical trial NCT06416475: The Effect of Mankai on Glycemic Control Among Patients With T2D
Official title: The Effect of Wolffia Globosa (Mankai) on Glycemic Control Among Patients With Type 2 Diabetes; A 3-month Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Keywords: clinical trial
Diabetes Mellitus, Type 2
nutritional intervention
Mankai Duckweed
Wolffia-globosa
polyphenols
Lead sponsor: Ben-Gurion University of the Negev
Sponsor class: OTHER
Collaborators: name: Soroka University Medical Center
First posted: 2024-05-16
Enrollment: 104
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A 3-month Randomized Controlled pilot Trial among 104 patients with T2D, who will be randomly allocated to consume comparable bottle volumes of either crude plant Mankai beverage (60ml Mankai) or water (60ml) on top of a standardized MediterraneanT2D-recommended healthy diet, after morning, lunch, and dinner over 3 months.
Primary purpose: TREATMENT

Brief summary: The investigators aim to explore the effect of daily supplementation of Wolfia globosa Mankai on HbA1c and insulin resistance response among participants with type 2 diabetes (T2D). The investigators hypothesize that adding daily Mankai to T2D's healthy nutrition might lower HbA1c and promote glycemic control.

Methods: A 3-month pilot RCT among 104 patients with T2D, with two intervention arms consuming comparable bottle volumes of either crude plant Mankai beverage (60ml Mankai) or water (60ml) 3 times/day postprandially over 3 months. Blood, urine, fecal, and clinical measures will be taken at 0 and 3 months. Overall appetite, food intake, symptoms, and medical treatment will be monitored.

Importance: This study's results will shed light on the effects of regular Mankai consumption on HbA1c among patients with T2D, which may reveal a new nutritional source to improve glycemic control in T2D.

Detailed description: Type 2 diabetes (T2D), most commonly stemming from sustained obesity, adiposity, and a sedentary lifestyle, is strongly associated with increased cardiovascular risk. Glycated hemoglobin A1c (HbA1c), reflecting glycemic control, is tightly related to cardiovascular risk. In the recent decade, several antihyperglycemic medications have been shown to modify cardiovascular risk among patients with established cardiovascular disease. Maintaining a healthy diet, preferably a Mediterranean-like diet, rich in plant-based protein and low in meat products, is the first-line intervention to promote glycemic control and reduce cardiovascular risk among T2D. However, whether specific nutritional products may independently promote glycemic control beyond medical treatment is unclear.

Mankai, a newly cultivated duckweed Wolffia-globosa strain, has been extensively studied in recent years. Mankai is rich in whole bioavailable protein, iron, and vitamin B12 and is rich in 200 different potent polyphenols, potentially affecting the metabolomic-gut-clinical axis. Mankai consumption, as a dominant part of the green-Mediterranean diet, was shown to promote weight loss, systemic inflammation lowering, and cardiometabolic risk reduction and was associated with regressions in hepatosteatosis, visceral abdominal adiposity, and proximal aortic stiffness among patients with abdominal obesity with or without T2D. Also, Mankai consumption was mainly linked with improved glycemic control, dramatic elevation in fasting Ghrelin levels, and insulin sensitivity recovery. Regular Mankai consumption promoted microbiome optimization, mainly impacting bacterial glucose metabolism and human glucose control.

In this proposed study, The investigators aim to explore the effect of daily consumption of 60mL crude plant Mankai beverage boost after 3 meals among patients with T2D on HbA1c levels (gold-standard for assessing glycemic control, primary outcome).

"Mankai" is a cultivated strain of Wolffia globosa, an aquatic plant, part of the family of plants known commonly as duckweeds. Duckweeds are elementary flowering aquatic plants floating on or beneath still or slow-moving water bodies.

There is a long history of using Wolffia species, particularly Wolffia globosa, as food, especially in Southeast Asia: Burma, Laos, and northern Thailand, where it has been used as a vegetable for many generations. The plant is cultivated locally in rain-fed open ponds, grown commercially in Thailand, and sold in local markets throughout Thailand and Laos. There are numerous ways of Wolffia globosa consumption and a variety of recipes, using it either as the main ingredient (such as Wolffia crisps or "Kaeng pum" - a popular vegetable dish in northeastern Thailand) or incorporating it in other foods (e.g., Wolffia-meat ball, fermented Wolffia-meat sausage, Wolffia rice noodle, Wolffia cookies, Wolffia bread, and various soups and salads). Moreover, Wolffia is known as one of the essential food sources in northern Thailand.

Along with its long history as a food source in Southeast Asia, it is recognized as an edible vegetable for humans in several databases, including the USDA (2014) GRIN database and a database dedicated to tropical species. For the proposed clinical trial, Mankai will be provided as a beverage, refrigerated at ±4°C. Participants will consume Mankai as an additional additive to a standardized healthy Mediterranean diet.

Eligibility 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 with HbA1c levels over 7%
* Medication stability for at least 3 months prior to Intervention initiation
* Adherence to medical follow-up in primary care clinic or diabetes-centered outpatient services

Exclusion Criteria:

* HbA1c lower than 7% or higher than 10%
* Known insulinopenia
* Treatment with coumadin (warfarin)
* Advanced renal failure
* Significantly disturbed liver enzymes (liver transaminases or bilirubin levels more than time three upper-normal-limit)
* A significant illness that might require hospitalization
* Regular Mankai consumption
* State of pregnancy or lactation
* Presence of active cancer or chemotherapy treatment in last three years
* Participation in another trial

Primary outcomes:
measure: HbA1c
timeFrame: Baseline and three months time points
measure: Fasting glycemic and insulin resistance profiling
timeFrame: Baseline and three months time points
Secondary outcomes:
measure: Lipid profile
timeFrame: Baseline and three months time points
measure: Lipid profile
timeFrame: Baseline and three months time points
measure: Hormones and adipokines
timeFrame: Baseline and three months time points
measure: Inflammatory biomarkers
timeFrame: Baseline and three months time points
measure: Hunger/satiety hormones
timeFrame: Baseline and three months time points
measure: CVD biomarkers
timeFrame: Baseline and three months time points
measure: CVD biomarkers
timeFrame: Baseline and three months time points
measure: CVD biomarkers
timeFrame: Baseline and three months time points
measure: CVD biomarkers
timeFrame: Baseline and three months time points
measure: Cardiometabolic health-Liver function (blood biomarkers)
timeFrame: Baseline and three months time points
measure: Cardiometabolic health-Liver function (blood biomarkers)
timeFrame: Baseline and three months time points
measure: HPA axis biomarkers
timeFrame: Baseline and three months time points
measure: HPA axis biomarkers
timeFrame: Baseline and three months time points
measure: HPA axis biomarkers
timeFrame: Baseline and three months time points
measure: HPG axis biomarkers
timeFrame: Baseline and three months time points
measure: HPG axis biomarkers
timeFrame: Baseline and three months time points
measure: HPG axis biomarkers
timeFrame: Baseline and three months time points
measure: HPG axis biomarkers
timeFrame: Baseline and three months time points
measure: Well being
timeFrame: Baseline and three months time points
measure: Microbiota profiling
timeFrame: Baseline and three months time points
measure: Weight
timeFrame: Baseline and three months time points
measure: Waist circumference
timeFrame: Baseline and three months time points
measure: BMI
timeFrame: Baseline and three months time points
measure: Blood pressure
timeFrame: Baseline and three months time points
measure: Resting pulse
timeFrame: Baseline and three months time points
measure: Urine biomarkers
timeFrame: Baseline and three months time points
measure: Urine biomarkers
timeFrame: Baseline and three months time points
measure: Urine biomarkers
timeFrame: Baseline and three months time points
measure: Urine biomarkers
timeFrame: Baseline and three months time points
measure: Urine biomarkers
timeFrame: Baseline and three months time points
Other outcomes:
Locations:
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center
Study officials:
affiliation: Soroka University Medical Center
name: Idit Liberty
role: PRINCIPAL_INVESTIGATOR
affiliation: Ben-Gurion University of the Negev
name: Iris Shai
role: STUDY_DIRECTOR
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