A1Cantus vs. Placebo

May 13, 2026 updated by: University of California, Riverside

Double-Blind Randomized Controlled Trial of A1Cantus Drink vs. Placebo for Reduction of Ha1c

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Drink
The placebo drink will be formulated to closely match the active drink in taste, color and mouthfeel, while removing all active ingredients.
Other: Placebo 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.
Experimental: A1C Drink
The A1C drink is currently on the market with natural active ingredients.
Dietary supplement: A1C 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1C
Time Frame: 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
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypertension
Time Frame: 3 months
Change in systolic and diastolic blood pressure from baseline to three months
3 months
Body Mass Index (BMI)
Time Frame: 3 months
Change in body mass index from baseline to 3 months
3 months
Cholesterol
Time Frame: 3 months
Change in fasting LDL and HDL from baseline to three months
3 months
Change in A1C
Time Frame: 3 months
Percentage of participants whose A1C was lowered from Baseline to 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Riverside

Collaborators

A1Cantus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

December 15, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

May 7, 2026

First Submitted That Met QC Criteria

May 7, 2026

First Posted (Actual)

May 14, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A1C001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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