Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06416475
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-03-21
Brief Title:
The Effect of Mankai on Glycemic Control Among Patients With T2D
Sponsor:
Ben-Gurion University of the Negev
Organization:
Ben-Gurion University of the Negev
Study Overview
Official Title:
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
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 T2Ds 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 timesday 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 studys 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
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 timesday 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 studys 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 eg 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 4C Participants will consume Mankai as an additional additive to a standardized healthy Mediterranean diet
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 eg 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 4C Participants will consume Mankai as an additional additive to a standardized healthy Mediterranean diet
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None