## Protocol Section
### Identification Module
**NCT ID:** NCT06416475

**Brief Title:** 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

#### Organization Study ID Info
**ID:** SOR-0259-23
#### Organization
**Class:** OTHER
**Full Name:** Ben-Gurion University of the Negev
### Status Module
#### Completion Date
**Date:** 2024-08-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2024-08-08

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-30

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-21
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Soroka University Medical Center

#### Lead Sponsor

**Class:** OTHER

**Name:** Ben-Gurion University of the Negev

#### Responsible Party

**Investigator Affiliation:** Ben-Gurion University of the Negev

**Investigator Full Name:** Iris Shai

**Investigator Title:** Prof. Iris Shai

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Diabetes Mellitus, Type 2

**Keywords:**

- clinical trial

- Diabetes Mellitus, Type 2

- nutritional intervention

- Mankai Duckweed

- Wolffia-globosa

- polyphenols

### Design Module

#### Design Info

**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.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 104

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Three times a day supplementation of postprandial Mankai duckweed drink (60mL crude plant Mankai beverage) right after breakfast, lunch, and dinner while maintaining the recommended Mediterranean diet lifestyle and medical treatment.

**Intervention Names:**

- Dietary Supplement: Mankai supplementation

**Label:** Mankai supplementation group

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Three times a day consumption of postprandial water (60mL) right after breakfast, lunch, and dinner while maintaining the recommended Mediterranean diet lifestyle and medical treatment.

**Intervention Names:**

- Other: Water consumption

**Label:** Water group

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Mankai supplementation group

**Description:** The overall dose of the three Mankai duckweed beverages/day contains \~10 grams of dry matter.

**Name:** Mankai supplementation

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- Water group

**Description:** Water consumption

**Name:** Water consumption

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Glycated hemoglobin-HbA1c; as detected by a standard laboratory measure

**Measure:** HbA1c

**Time Frame:** Baseline and three months time points

**Description:** Fasting glycemic and insulin resistance profiling \[using calculated homeostatic model assessment of insulin resistance (HOMA-IR) as detected by laboratory assessment\]

**Measure:** Fasting glycemic and insulin resistance profiling

**Time Frame:** Baseline and three months time points

#### Secondary Outcomes

**Description:** Changes in lipid biomarkers (blood draw), such as LDL (mg/dL), HDL (mg/dL), TG (mg/dL), total cholesterol (mg/dL), Lipoprotein (a) (mg/dL)

**Measure:** Lipid profile

**Time Frame:** Baseline and three months time points

**Description:** Changes in lipid biomarkers (blood draw), such as apo(A)1(g/L), apo(B)100 (g/L)

**Measure:** Lipid profile

**Time Frame:** Baseline and three months time points

**Description:** Changes in hormone and adipokine biomarkers (blood draw); such as total adiponectin (ug/ml), RBP4 (ug/ml), chemerin (ng/ml), vaspin (ng/ml), omentin-1(ng/ml), MCP-1 (pg/ml)

**Measure:** Hormones and adipokines

**Time Frame:** Baseline and three months time points

**Description:** Changes in inflammatory biomarkers (blood draw); such as CRP (mg/dl), IL-1 (pg/mL), IL-6 (pg/mL), IL10 (pg/mL), IL-17 (pg/mL), TNF-alpha (pg/mL)

**Measure:** Inflammatory biomarkers

**Time Frame:** Baseline and three months time points

**Description:** Changes in Hunger/satiety hormones (blood draw); such as leptin(ng/ml), ghrelin(pg/ml), neuropeptide Y (NPY) (pg/ml), cholecystokinin (CCK) (pmol/L), peptide YY (PYY) (pmol/L), and incretins (e.g., oxyntomodulin (pmol/L) and glucagon-like peptide-1 (GLP-1)(pmol/L)\]

**Measure:** Hunger/satiety hormones

**Time Frame:** Baseline and three months time points

**Description:** Changes in CVD biomarkers (blood draw); such as Homocysteine (ug/dL)

**Measure:** CVD biomarkers

**Time Frame:** Baseline and three months time points

**Description:** Changes in CVD biomarkers (blood draw); such as Renin (iU/ml)

**Measure:** CVD biomarkers

**Time Frame:** Baseline and three months time points

**Description:** Changes in CVD biomarkers (blood draw); such as Troponin (cardiac troponin I and T) (ng/ml)

**Measure:** CVD biomarkers

**Time Frame:** Baseline and three months time points

**Description:** Changes in CVD biomarkers (blood draw); such as NT-pro-BNP (pg/ml)

**Measure:** CVD biomarkers

**Time Frame:** Baseline and three months time points

**Description:** Changes in liver function biomarkers (blood draw); such as Alkaline Phosphatase (U/L), Alanine Aminotransferase (U/L), Aspartate Aminotransferase (U/L), bilirubin (mg/dL)

**Measure:** Cardiometabolic health-Liver function (blood biomarkers)

**Time Frame:** Baseline and three months time points

**Description:** Changes in liver function biomarkers (blood draw); such as bilirubin (mg/dL)

**Measure:** Cardiometabolic health-Liver function (blood biomarkers)

**Time Frame:** Baseline and three months time points

**Description:** Changes in HPA axis biomarkers (blood draw); such as ACTH (pmol/L)

**Measure:** HPA axis biomarkers

**Time Frame:** Baseline and three months time points

**Description:** Changes in HPA axis biomarkers (blood draw); such as cortisol (nmol/L)

**Measure:** HPA axis biomarkers

**Time Frame:** Baseline and three months time points

**Description:** Changes in HPA axis biomarkers (blood draw); such as cortisone (microg/L)

**Measure:** HPA axis biomarkers

**Time Frame:** Baseline and three months time points

**Description:** Changes in HPG axis; such as Testosterone (nmol/L), SHBG (nmol/L), IGF1 (nmol/L)

**Measure:** HPG axis biomarkers

**Time Frame:** Baseline and three months time points

**Description:** Changes in HPG axis; such as LH (IU/mL)

**Measure:** HPG axis biomarkers

**Time Frame:** Baseline and three months time points

**Description:** Changes in HPG axis; such as FSH (IU/L)

**Measure:** HPG axis biomarkers

**Time Frame:** Baseline and three months time points

**Description:** Changes in HPG axis; such as GH (pmol/L)

**Measure:** HPG axis biomarkers

**Time Frame:** Baseline and three months time points

**Description:** Assessed by questionnaires; 1. Screening questionnaire 2. I-MEDAS (Mediterranean Diet Adherence Screener) questionnaire - the 14-item MEDAS questionnaire (scale 0-17, higher score indicated higher adherence to Mediterranean diets), 3. Validated physical activity questionnaire, 4. Symptoms questionnaire, 5. Medical questionnaire, and 6. A follow-up questionnaire.

**Measure:** Well being

**Time Frame:** Baseline and three months time points

**Description:** Shannon Diversity Index (where 0 indicates no diversity, there is no upper limit to the index, usually between 1.5 - 3.5).

**Measure:** Microbiota profiling

**Time Frame:** Baseline and three months time points

**Description:** Bodyweight will be measured without shoes to the nearest 0.1 kg.

**Measure:** Weight

**Time Frame:** Baseline and three months time points

**Description:** WC will be measured halfway between the last rib and the iliac crest to the nearest millimeter by standard procedures using a 150-cm anthropometric measuring tape.

**Measure:** Waist circumference

**Time Frame:** Baseline and three months time points

**Description:** Weight and Height will be combined to report BMI in kg/m\^2

**Measure:** BMI

**Time Frame:** Baseline and three months time points

**Description:** Blood pressure will be measured and determined using an automated system in mmHg. Both systolic and diastolic blood pressure will be measured.

**Measure:** Blood pressure

**Time Frame:** Baseline and three months time points

**Description:** Pulse will be measured and determined using an automated system in Beats per minute.

**Measure:** Resting pulse

**Time Frame:** Baseline and three months time points

**Description:** Urine albumin (mg/dL)

**Measure:** Urine biomarkers

**Time Frame:** Baseline and three months time points

**Description:** UACR (mg/g)

**Measure:** Urine biomarkers

**Time Frame:** Baseline and three months time points

**Description:** Urine creatinine (g/dL)

**Measure:** Urine biomarkers

**Time Frame:** Baseline and three months time points

**Description:** eGFR (ml/min/1.73m\^2)

**Measure:** Urine biomarkers

**Time Frame:** Baseline and three months time points

**Description:** Urine polyphenols for adherence as measured by mass spectrometry.

**Measure:** Urine biomarkers

**Time Frame:** Baseline and three months time points

### Eligibility Module

**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

**Minimum Age:** 30 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Be'er Sheva

**Country:** Israel

**Facility:** Soroka Medical Center

#### Overall Officials

**Official 1:**

**Affiliation:** Soroka University Medical Center

**Name:** Idit Liberty

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Ben-Gurion University of the Negev

**Name:** Iris Shai

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

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**PMID:** 30915471

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## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes Mellitus

- ID: M7119

- Name: Diabetes Mellitus, Type 2

- Relevance: HIGH

- As Found: Diabetes Mellitus, Type 2

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000003924

- Term: Diabetes Mellitus, Type 2

### Misc Info Module

- Version Holder: 2024-05-31
