Type 2 Diabetes
Conditions
Brief summary
The investigators will conduct a randomized controlled 2-arm parallel trial of A1c Drink vs. Placebo over a 3-month period and compare changes in Ha1c from baseline to 3 months. Investigator and study personnel, as well as participants, will be blinded to drink assignments.
Interventions
OTHERPlacebo drink
In the placebo arm, participants will drink the placebo drink BID for 3 months as instructed. Both the active and placebo drinks will be identical in can size (12 oz slim can), packaging format, and visual appearance.
DIETARY_SUPPLEMENTA1C Drink
In the experimental arm, participants will drink the A1C drink BID for 3 months as instructed. Both the active and placebo drinks will be identical in can size (12 oz slim can), packaging format, and visual appearance.
Sponsors
University of California, Riverside
A1Cantus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults 21 years of age or older and not older than 75 recruited from UCR Health * Clinical diagnosis of type II DM with Ha1c \>= 8 but less than or equal to 10 * Stable medications for at least 6 months * Speak Spanish and/or English * Sign an informed consent form * No other members in their household are participating in the study
Exclusion criteria
* Patients \<21 years of age, who do not have type II DM, whose Ha1c is less than 8 or \> 10, * Have major complications of diabetes, including CKD, diabetic retinopathy, ADVD risk \> 5, or history of CVD/stroke * Do not speak and understand either English or Spanish well * Allergic to cinnamon * Severe diseases, such as cancer * Compromised immune system * Eating disorders * BMI of 40 or higher * Already have a family member participating in the study * Substance use disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1C | 3 months | Change in Ha1c from baseline to 3 months. To test the efficacy of the A1Cantus drink in improving glycemic control in patients with Type II Diabetes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cholesterol | 3 months | Change in fasting LDL and HDL from baseline to three months |
| Change in A1C | 3 months | Percentage of participants whose A1C was lowered from Baseline to 3 months |
| Hypertension | 3 months | Change in systolic and diastolic blood pressure from baseline to three months |
| Body Mass Index (BMI) | 3 months | Change in body mass index from baseline to 3 months |
Countries
United States
Contacts
CONTACTElizabeth Jacobs, MD, MPP
Outcome results
None listed