The Effect of Mankai on Glycemic Control Among Patients With T2D
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Dietary Supplement: Mankai supplementationOther: Water consumption
- Registration Number
- NCT06416475
- Lead Sponsor
- Ben-Gurion University of the Negev
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 104
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mankai supplementation group Mankai supplementation 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. Water group Water consumption 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.
- Primary Outcome Measures
Name Time Method HbA1c Baseline and three months time points Glycated hemoglobin-HbA1c; as detected by a standard laboratory measure
Fasting glycemic and insulin resistance profiling Baseline and three months time points Fasting glycemic and insulin resistance profiling \[using calculated homeostatic model assessment of insulin resistance (HOMA-IR) as detected by laboratory assessment\]
- Secondary Outcome Measures
Name Time Method HPG axis biomarkers Baseline and three months time points Changes in HPG axis; such as GH (pmol/L)
Well being Baseline and three months time points 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.
Hormones and adipokines Baseline and three months time points 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)
Cardiometabolic health-Liver function (blood biomarkers) Baseline and three months time points Changes in liver function biomarkers (blood draw); such as bilirubin (mg/dL)
HPA axis biomarkers Baseline and three months time points Changes in HPA axis biomarkers (blood draw); such as cortisone (microg/L)
Weight Baseline and three months time points Bodyweight will be measured without shoes to the nearest 0.1 kg.
Resting pulse Baseline and three months time points Pulse will be measured and determined using an automated system in Beats per minute.
Urine biomarkers Baseline and three months time points Urine polyphenols for adherence as measured by mass spectrometry.
Lipid profile Baseline and three months time points Changes in lipid biomarkers (blood draw), such as apo(A)1(g/L), apo(B)100 (g/L)
Hunger/satiety hormones Baseline and three months time points 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)\]
Microbiota profiling Baseline and three months time points Shannon Diversity Index (where 0 indicates no diversity, there is no upper limit to the index, usually between 1.5 - 3.5).
Waist circumference Baseline and three months time points 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.
BMI Baseline and three months time points Weight and Height will be combined to report BMI in kg/m\^2
Blood pressure Baseline and three months time points Blood pressure will be measured and determined using an automated system in mmHg. Both systolic and diastolic blood pressure will be measured.
Inflammatory biomarkers Baseline and three months time points 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)
CVD biomarkers Baseline and three months time points Changes in CVD biomarkers (blood draw); such as NT-pro-BNP (pg/ml)
Trial Locations
- Locations (1)
Soroka Medical Center
🇮🇱Be'er Sheva, Israel