CuraLin Herbal Supplement for Type 2 Diabetes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05267925|
Recruitment Status : Suspended (Pending additional product QA)
First Posted : March 7, 2022
Last Update Posted : April 22, 2022
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Dietary Supplement: CuraLin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single-arm, Open Label Clinical Trial of CuraLin in Type 2 Diabetes|
|Actual Study Start Date :||January 8, 2022|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
All participants will be asked to take the dietary herbal supplement CuraLin for the duration of the study. All participants will take 2 capsules orally, three times per day following meals for 12 weeks.
Dietary Supplement: CuraLin
CuraLin™ is a dietary supplement manufactured by NutraStar Inc. and sold by CuraLife; it is a blend of nine ayurvedic plants and herbs.
The CuraLin formulation contains the following ingredients (per 2 capsules):
- Hemoglobin A1C [ Time Frame: 12 Weeks ]Hemoglobin is the oxygen-carrying component of red blood cells. In the presence of sustained elevated glucose levels, glucose non-enzymatically binds to hemoglobin, leading to the formation of glycated hemoglobin, and later, advanced glycation end products (AGEs). AGEs are responsible for many of the complications of T2DM. Thus, HbA1c, in conjunction with fasting blood glucose, is used as diagnostic criteria for T2DM (HbA1c ≥ 6.5%), and is used as a marker of glycemic control in diabetic individuals. As the life cycle of a red blood cell is approximately 90 days, serum HbA1c measurements are a snapshot of the percent of glycated hemoglobin over the prior two to three months, and thus serve as a snapshot of glycemic control in T2DM. HbA1c will be expressed as a percentage.
- Gamma-glutamyltransferase (GGT) [ Time Frame: 12 Weeks ]Concentration of the enzyme Gamma-glutamyltransferase (GGT) in the blood is considered a measure of liver inflammation and oxidative stress. Liver function markers will be expressed as IU/L.
- Aspartate aminotransferase (AST) [ Time Frame: 12 Weeks ]Concentration of the enzyme aspartate aminotransferase (AST) in the blood is considered a measure of liver inflammation. Liver function markers will be expressed as IU/L.
- Alanine aminotransferase (ALT) [ Time Frame: 12 Weeks ]Concentration of the enzyme alanine aminotransferase (ALT) in the blood is considered a measure of liver inflammation. Liver function markers will be expressed as IU/L.
- Homeostatic Model Assessment of Insulin Resistance [ Time Frame: 12 Weeks ]The Homeostatic model assessment (HOMA) of β- cell function and insulin resistance (IR) is a calculated ratio of fasting plasma insulin to glucose, and reflects the balance between hepatic glucose output and β- cell insulin secretion. It has been used in greater than 500 research publications to provide an estimate of insulin sensitivity and β- cell function, and is used to predict the level of insulin resistance. In patients with T2DM, the HOMA-IR is able to assess changes in β-cell function and IR, and thus, provide a reflection of treatment effects. The HOMA-IR will be expressed as a number, where '1' is considered normal, and anything above '1' is reflective of some degree of insulin resistance.
- Fasting Blood Glucose [ Time Frame: 12 Weeks ]FBG, in conjunction with HbA1c, is used as a diagnostic criteria for T2DM (FBG ≥ 126 mg/dL), and is used as a marker of glycemic control in diabetic individuals. Levels are associated with future cardiac events and other complications of T2DM. FBG will be expressed in mg/dL.
- Estimated glomerular filtration rate [ Time Frame: 12 Weeks ]As estimation of the rate at which the kidneys filter and reabsorb protein based on age, ethnicity and blood creatinine.
- Triglycerides [ Time Frame: 12 Weeks ]The concentration of triglyceride-based fats in the blood is a cardiovascular risk factor.
- LDL:HDL ratio [ Time Frame: 12 Weeks ]The ratio of the concentration of low density lipoproteins (LDL) to high density lipoproteins (HDL) is a cardiovascular risk factor.
- BMI [ Time Frame: 12 Weeks ]Elevated body weight, manifesting as being overweight or obese, can cause and/or lead to exacerbations in a variety of pathologies, including T2DM, dyslipidemia, liver dysfunction, renal dysfunction, and cardiovascular disease. Thus, changes in weight are clinically meaningful in a T2DM population. This outcome measure is an important correlate and is of low burden to participants. Additionally, we will measure height in order to calculate Body Mass Index (BMI). Body weight will be expressed in pounds, height in inches, and BMI in kg/m2.
- Creatinine [ Time Frame: 12 weeks ]The concentration of creatinine in the blood is a measure of renal function.
- Blood urea nitrogen (BUN) [ Time Frame: 12 weeks ]The concentration of urea-based nitrogen in the blood is a measure of renal function.
- PROMIS-29 Health-related Quality of Life [ Time Frame: 12 Weeks ]PROMIS-29 will measure health-related quality of life and is a validated, 29 question survey divided into seven sub-domains of function including physical functioning, social function, pain interference, pain intensity, sleep, depression, and anxiety.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05267925
|United States, Oregon|
|National University of Natural Medicine|
|Portland, Oregon, United States, 97201|
|United States, Washington|
|Institute of Complementary Medicine|
|Seattle, Washington, United States, 98122|