Effect of Cinnamon Extract on Insulin Resistance in Polycystic Ovary Syndrome (Eccentric)

August 23, 2021 updated by: Leanne Redman, Pennington Biomedical Research Center

Phase 1 Study That Will Compare 12 Weeks of Supplementation With Cinnamon Extract on the Action of Insulin and Blood Sugar (Glucose) With 12 Weeks of Supplementation With a Placebo.

The purpose of this study is to determine whether Cinnamon from the Cassae Plant is effective in the body as insulin could lower blood sugar levels.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Insulin resistance is a condition in which body cells do not fully respond to the action of insulin, a hormone that controls the amount of sugar (glucose) in the blood. As a result, blood sugar levels become abnormally high. Insulin resistance is common in women with polycystic ovary syndrome (PCOS). This study involves the administration of a nutritional supplement (cinnamon extract). The cinnamon extract like regular cinnamon powder comes from the bark of Cinnamon Cassae plant. It is believed that cinnamon may act in the same way as insulin and therefore could potentially improve insulin resistance and help to lower blood sugar (glucose) levels.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

Contacts and Locations

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

Study Locations

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center

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

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 20 to 40 years of age
  • Have a body mass index 25-40 kg/m2
  • Have a sedentary lifestyle (participated in less than 30 minutes of physical activity 3 days per week over the last 6 months)
  • History of irregular menstrual cycles (fewer than 6 cycles in past year)
  • Excess androgen (to be measured at screening)
  • Willing to supplement normal diet with cinnamon extract and a placebo for 12 weeks
  • You can stay overnight at Pennington Center three times over the next six months

Exclusion Criteria:

  • Do not meet our diagnostic criteria for polycystic ovary syndrome
  • Have heart disease, lung disease, liver disease, blood disease, kidney disease, type 1 or 2 diabetes, or any other disease that in the opinion of the doctor might make you ineligible.
  • Have cancer (active malignancy with or without concurrent chemotherapy).
  • Abuse alcohol or illegal drugs.
  • Smoke or have smoked within the previous 6 months. No smoking will be permitted during the study.
  • Have donated blood within 30 days prior to randomization date.
  • Have a hemoglobin, hematocrit, red blood cell, or iron level below the normal lower limit at screening.
  • Taking medications that alter your glucose metabolism, (30 minute or more, 4 or more times per week over the past year.)
  • Unwilling or unable to adhere to the clinical evaluation schedule over the entire six-month follow-up period.

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: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Cinnamon Supplementation
A 500mg (consumed as two, 250mg capsules) of cinnamon extract (Cinnamon Bark P.E> 20:1) will be consumed before meals, three times per day.
Dietary supplement: Cinnamon Supplementation
1, 3, or 6g of cinnamon per day for 40 days
Other Names:
  • The bark of Cinnamoni Cassae
PLACEBO_COMPARATOR: Placebo
A 500 mg placebo (wheat flour) will be consumed before meals, three times per day.
Dietary supplement: Placebo (wheat flour)
1, 3, or 6g of placebo per day for 40 days
Other Names:
  • 500mg placebo (wheat flour) will be cnsumed before meals, three times per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Insulin sensitivity measured by the euglycemic hyperinsulinemic clamp
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Pennington Biomedical Research Center

Investigators

  • Principal Investigator: Leanne Redman, PhD, Pennington Biomedical Research Center

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 (ACTUAL)

August 1, 2009

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

August 31, 2009

First Submitted That Met QC Criteria

September 1, 2009

First Posted (ESTIMATE)

September 2, 2009

Study Record Updates

Last Update Posted (ACTUAL)

August 25, 2021

Last Update Submitted That Met QC Criteria

August 23, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBRC 29010

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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