NCT07585630

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2 type-2-diabetes

Timeline
24mo left

Started Jun 2026

Typical duration for phase_2 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 14, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

June 15, 2026

Expected
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2027

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

1.5 years

First QC Date

May 7, 2026

Last Update Submit

May 13, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1C

    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 Outcomes (4)

  • Change in A1C

    3 months

  • Hypertension

    3 months

  • Body Mass Index (BMI)

    3 months

  • Cholesterol

    3 months

Study Arms (2)

Placebo Drink

PLACEBO COMPARATOR

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

A1C Drink

EXPERIMENTAL

The A1C drink is currently on the market with natural active ingredients.

Dietary Supplement: A1C Drink

Interventions

A1C DrinkDIETARY_SUPPLEMENT

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.

A1C 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.

Placebo Drink

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCR Health

Riverside, California, 92521, United States

Location

Related Publications (3)

  • Centers for Disease Control and Prevention. (2026) National Diabetes Statistics Report, 11 Mar 2026. Available at https://gis.cdc.gov/grasp/diabetes/diabetesatlas-statsreport.html.

    BACKGROUND
  • Lorestanifar M, Mosayebi Molasaraei M, Jashaninejad R, Khoshmanesh S, Doosti-Irani A. The prevalence of uncontrolled diabetes mellitus in patients with type 2 diabetes: a multicenter cross-sectional study. J Diabetes Metab Disord. 2023 Mar 17;22(1):787-792. doi: 10.1007/s40200-023-01201-9. eCollection 2023 Jun.

    PMID: 37255779BACKGROUND
  • https://diabetes.org/about-diabetes/complications

    BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Elizabeth Jacobs, MD, MPP

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2026

First Posted

May 14, 2026

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

December 15, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

May 18, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations