Effect of Cinnamon Extract on Insulin Resistance in Polycystic Ovary Syndrome

NCT ID: NCT00970541

Last Updated: 2021-08-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2013-06-30

Brief Summary

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.

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.

Conditions

Polycystic Ovary Syndrome; Insulin Resistance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Cinnamon Supplementation

Intervention Type: DIETARY_SUPPLEMENT

1, 3, or 6g of cinnamon per day for 40 days

Placebo

A 500 mg placebo (wheat flour) will be consumed before meals, three times per day.

Group Type: PLACEBO_COMPARATOR

Placebo (wheat flour)

Intervention Type: DIETARY_SUPPLEMENT

1, 3, or 6g of placebo per day for 40 days

Interventions

Cinnamon Supplementation

1, 3, or 6g of cinnamon per day for 40 days

Intervention Type: DIETARY_SUPPLEMENT

Placebo (wheat flour)

1, 3, or 6g of placebo per day for 40 days

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

The bark of Cinnamoni Cassae; 500mg placebo (wheat flour) will be cnsumed before meals, three times per day.

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pennington Biomedical Research Center

OTHER

Sponsor Role: lead

Responsible Party

Leanne Redman

Princiapal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Leanne Redman, PhD

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Locations

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Countries

United States

Other Identifiers

PBRC 29010

Identifier Type: -

Identifier Source: org_study_id