The Effect of Wolffia Globosa (Mankai) on Glycemic Control Among Patients With Type 2 Diabetes; A 3-month Randomized Controlled Pilot Trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中(未招募)
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- HbA1c
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
HbA1c
时间窗: Baseline and three months time points
Glycated hemoglobin-HbA1c; as detected by a standard laboratory measure
Fasting glycemic and insulin resistance profiling
时间窗: Baseline and three months time points
Fasting glycemic and insulin resistance profiling \[using calculated homeostatic model assessment of insulin resistance (HOMA-IR) as detected by laboratory assessment\]
次要结局
- Well being(Baseline and three months time points)
- Hormones and adipokines(Baseline and three months time points)
- Weight(Baseline and three months time points)
- Resting pulse(Baseline and three months time points)
- Lipid profile(Baseline and three months time points)
- Hunger/satiety hormones(Baseline and three months time points)
- Microbiota profiling(Baseline and three months time points)
- Waist circumference(Baseline and three months time points)
- BMI(Baseline and three months time points)
- Blood pressure(Baseline and three months time points)
- CVD biomarkers(Baseline and three months time points)
- Inflammatory biomarkers(Baseline and three months time points)
- Cardiometabolic health-Liver function (blood biomarkers)(Baseline and three months time points)
- HPA axis biomarkers(Baseline and three months time points)
- HPG axis biomarkers(Baseline and three months time points)
- Urine biomarkers(Baseline and three months time points)
研究者
Iris Shai
Prof. Iris Shai
Ben-Gurion University of the Negev
