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The Effect of Mankai on Glycemic Control Among Patients With T2D

The Effect of Wolffia Globosa (Mankai) on Glycemic Control Among Patients With Type 2 Diabetes; A 3-month Randomized Controlled Pilot Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06416475
Enrollment
104
Registered
2024-05-16
Start date
2024-04-30
Completion date
2024-08-15
Last updated
2024-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

clinical trial, Diabetes Mellitus, Type 2, nutritional intervention, Mankai Duckweed, Wolffia-globosa, polyphenols

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.

Interventions

DIETARY_SUPPLEMENTMankai supplementation

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

Water consumption

Sponsors

Soroka University Medical Center
CollaboratorOTHER
Ben-Gurion University of the Negev
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
HbA1cBaseline and three months time pointsGlycated hemoglobin-HbA1c; as detected by a standard laboratory measure
Fasting glycemic and insulin resistance profilingBaseline and three months time pointsFasting glycemic and insulin resistance profiling \[using calculated homeostatic model assessment of insulin resistance (HOMA-IR) as detected by laboratory assessment\]

Secondary

MeasureTime frameDescription
Hormones and adipokinesBaseline and three months time pointsChanges 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)
Inflammatory biomarkersBaseline and three months time pointsChanges 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)
Hunger/satiety hormonesBaseline and three months time pointsChanges 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)\]
CVD biomarkersBaseline and three months time pointsChanges in CVD biomarkers (blood draw); such as Homocysteine (ug/dL)
Cardiometabolic health-Liver function (blood biomarkers)Baseline and three months time pointsChanges in liver function biomarkers (blood draw); such as Alkaline Phosphatase (U/L), Alanine Aminotransferase (U/L), Aspartate Aminotransferase (U/L), bilirubin (mg/dL)
HPA axis biomarkersBaseline and three months time pointsChanges in HPA axis biomarkers (blood draw); such as ACTH (pmol/L)
Well beingBaseline and three months time pointsAssessed 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.
HPG axis biomarkersBaseline and three months time pointsChanges in HPG axis; such as Testosterone (nmol/L), SHBG (nmol/L), IGF1 (nmol/L)
WeightBaseline and three months time pointsBodyweight will be measured without shoes to the nearest 0.1 kg.
Waist circumferenceBaseline and three months time pointsWC 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.
BMIBaseline and three months time pointsWeight and Height will be combined to report BMI in kg/m\^2
Blood pressureBaseline and three months time pointsBlood pressure will be measured and determined using an automated system in mmHg. Both systolic and diastolic blood pressure will be measured.
Resting pulseBaseline and three months time pointsPulse will be measured and determined using an automated system in Beats per minute.
Urine biomarkersBaseline and three months time pointsUrine albumin (mg/dL)
Microbiota profilingBaseline and three months time pointsShannon Diversity Index (where 0 indicates no diversity, there is no upper limit to the index, usually between 1.5 - 3.5).
Lipid profileBaseline and three months time pointsChanges in lipid biomarkers (blood draw), such as LDL (mg/dL), HDL (mg/dL), TG (mg/dL), total cholesterol (mg/dL), Lipoprotein (a) (mg/dL)

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026