Health TrialsbyHealthPanel

A1Cantus vs. Placebo

ConditionType 2 Diabetes
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-75
SponsorUniversity of California, Riverside

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • A1C Drink

    Dietary 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.

  • Placebo drink

    Other intervention

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Placebo DrinkPlacebo comparator 1 intervention
Group B: A1C DrinkExperimental treatment 1 intervention

Trial outcomes

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

Time frame
3 months

Secondary outcomes

1

Change in A1C

Percentage of participants whose A1C was lowered from Baseline to 3 months

Time frame
3 months
2

Hypertension

Change in systolic and diastolic blood pressure from baseline to three months

Time frame
3 months
3

Body Mass Index (BMI)

Change in body mass index from baseline to 3 months

Time frame
3 months
4

Cholesterol

Change in fasting LDL and HDL from baseline to three months

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Riverside

Lead sponsor

A1Cantus

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: