Clinical trial NCT00331279: The Effect of Cinnamon Extract on Insulin Resistance Parameters in Polycystic Ovary Syndrome: A Pilot Study
Official title: The Effect of Cinnamon Extract on Insulin Resistance Parameters in Polycystic Ovary Syndrome: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Polycystic Ovary Syndrome
Keywords: polycystic ovary syndrome
insulin resistance
cinnamon
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: USDA Beltsville Human Nutrition Research Center
name: Integrity Neutraceuticals, Inc. Sarasota, FL
First posted: 2006-05-29
Enrollment: 1
Sex: FEMALE
Minimum age (years): 23
Maximum age (years): 47
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether oral cinnamon extract are effective in reducing insulin resistance parameters in women with polycystic ovary syndrome.

Detailed description: Polycystic ovary syndrome (PCOS) is a very common condition found in women of childbearing age. PCOS patients often have irregular periods, extra hair growth, or difficulty becoming pregnant. The syndrome can also be associated with more serious conditions such as heart disease, diabetes, or cancer of the uterus.

Although no one knows the cause of the syndrome, scientific studies showed that having too much insulin can be one of the reasons. In fact, almost every overweight woman with PCOS has been found to have high insulin levels.

Medications that lower the body's insulin level used to treat people with diabetes mellitus have also been used very successfully to treat some of the symptoms of PCOS such as irregular periods.

Recently studies using rats and mice have shown that a commonly used spice, cinnamon, may also reduce the body's insulin level. Another study showed that daily use of cinnamon for forty days lowered the blood sugar level in patients with diabetes. The purpose of this study is to see if cinnamon can lower the insulin level in women with PCOS. If so, it can also be used as a treatment for irregular periods as well.

Half of the patients in the study will take premade cinnamon extract pills twice a day while the other half will take placebo pills (pills with no cinnamon extract) twice a day for eight weeks. Blood tests measuring insulin, substances important for insulin action, cholesterol, and glucose (sugar) will be taken before and after the eight weeks of medication. A total of three separate visits will be needed to finish the study. At the end of the study, we will then compare the blood glucose, insulin, and cholesterol levels between the patients that took cinnamon and the patients that took placebo.

Eligibility criteria: Inclusion Criteria:

* Polycystic ovary syndrome

Exclusion Criteria:

* Diabetes mellitus, hyperprolactinemia, thyroid disorders, and hypertension

Primary outcomes:
measure: Fasting glucose
timeFrame: Duration of study
measure: Fasting insulin
timeFrame: Duration of study
measure: HOMA-IR
timeFrame: Up to 8 weeks after treatment
measure: QUICKI
timeFrame: Up to 8 weeks after treatment
measure: Insulin sensitivity index (Matsuda)
timeFrame: Up to 8 weeks after treatment
Secondary outcomes:
measure: Total testosterone
timeFrame: Up to 8 weeks after treatment
measure: Sex hormbone binding globulin
timeFrame: Up to 8 weeks after treatment
Other outcomes:
Locations:
city: New York
country: United States
facility: Center for Women's Reproductive Care
state: New York
Study officials:
affiliation: Columbia University
name: Rogerio Lobo, M.D.
role: PRINCIPAL_INVESTIGATOR
References: