Effect of Cinnamon Extract on Insulin Resistance in Polycystic Ovary Syndrome

Phase 1

Terminated

• Conditions: Polycystic Ovary Syndrome; Insulin Resistance
• Interventions: Dietary Supplement: Cinnamon Supplementation; Dietary Supplement: Placebo (wheat flour)

• Registration Number: NCT00970541
• Lead Sponsor: Pennington Biomedical Research Center

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.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-31
• Study First Submitted QC: 2009-09-01
• Study First Posted: 2009-09-02
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-08-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cinnamon Supplementation	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.
Placebo	Placebo (wheat flour)	A 500 mg placebo (wheat flour) will be consumed before meals, three times per day.

Primary Outcome Measures

Name	Time	Method
Insulin sensitivity measured by the euglycemic hyperinsulinemic clamp	6 months

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States