Polycystic Ovary Syndrome
Conditions
Keywords
PCOS, Insulin resistance, Cinnamon extract, Irregular menstrual cycles, Ovarian cysts
Brief summary
The primary purpose of this follow-up study is to determine if cinnamon can restore menstrual cyclicity in Polycystic Ovary Syndrome (PCOS) subjects with oligomenorrhea. As a secondary purpose, the investigators intend to confirm the salutatory effect of cinnamon on insulin resistance in larger group of study subjects. 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. 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. Our own study also showed that using cinnamon everyday for 8 weeks decreased insulin resistance in women with PCOS. The purpose of this study is to see if cinnamon can help women with PCOS have more regular periods.
Detailed description
All patients will eat a balanced diet containing 1800 calories per day, but half of the patients in the study will take pre-made cinnamon extract pills three times a day, while the other half will take placebo pills (pills with no cinnamon extract) three times a day for 6 months. During this time, every patient will keep track of her period on a calendar. Blood tests measuring insulin, substances important for insulin action, cholesterol, and glucose (sugar) will be taken before and after the 6 months of medication. A total of 8 separate visits will be needed to finish the study. At the end of the study, the investigators will then compare the number of periods, blood glucose, insulin, and cholesterol levels between the patients that took cinnamon and the patients that took placebo.
Interventions
DRUGCinnamon Extract
Purified aqueous abstract of cinnamon in 125mg capsules, which would be taken orally before each meal, for a total of 1,500mg/day for 6 months.
DIETARY_SUPPLEMENTPlacebo
Placebo capsules containing ground cereal.
Sponsors
Integrity Nutraceuticals International
Rogerio A. Lobo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged greater than 18 years of age * Ability to understand and willingness to comply with the study protocol * Written informed consent * Patients meeting the Rotterdam PCOS workshop criteria for polycystic ovary syndrome, defined by oligomenorrhea or amenorrhea and at least one of the following two signs: clinical or biochemical evidence of hyperandrogenism or ultrasound finding of polycystic appearing ovaries.
Exclusion criteria
* Current pregnancy or lactation * Liver disease or elevated liver enzymes * Established diagnosis of diabetes mellitus * Abnormal serum glucose levels either at fasting or after the 2-hr oral glucose tolerance test meeting criteria for the diagnosis of diabetes mellitus according to the American Diabetes Association. * Insulin sensitizing treatment within 3 months prior to or during the eight week study period. * Hormonal treatment involving estrogen or progesterone 3 months prior to or during the study period, with the exception of medroxyprogesterone acetate for withdrawal bleeding. * Systemic or inhaled corticosteroids. * Known hypersensitive reaction to cinnamon. * Patients with seizure disorders, known cardiovascular disease, or cerebrovascular disease. * Body mass index (BMI)range 20-50 (excluding all women with BMI under 20 or over 50).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Menses During the Six Month Study Period. | Up to 6 months | Ovulatory cycles will be confirmed by serum progesterone levels. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Insulin Resistance | Baseline and 6 months | The changes in insulin resistance parameters in overweight patients with PCOS between baseline and after 6 months of daily cinnamon compared to the corresponding change in patients receiving 6 months of placebo. Higher values of insulin resistance represent a worse outcome. A higher value Homeostasis Model of Insulin Resistance indicates more insulin resistance so higher values are worse outcomes (a score of \>2 is considered healthy for adults with scores \>5 being considered severe insulin resistance). For the Quant. Insulin Sensitivity Check Index, a lower value indicates more insulin resistance so lower values are worse outcomes (values can range from .45, which is considered normal in health individuals and .30, which is characteristic of diabetes). |
| Change in Glucose Response | Baseline and 6 Months - fasting bloods, followed by glucose tolerance test with draws at 30, 60, and 120 minutes post glucose ingestion | Change in Glucose Response - area under the curve (AUC), trapezoidal method - in overweight patients with PCOS between baseline and after 6 months of daily cinnamon compared to the corresponding change in patient receiving 6 months of placebo. Fasting blood samples were drawn followed by a 2 hour glucose tolerance test with blood draws at 30, 60, and 120min post glucose ingestion. |
Countries
United States
Participant flow
Recruitment details
Advertizing in newspaper beginning in August 2011
Participants by arm
| Arm | Count |
|---|---|
| Cinnamon Extract Arm Purified aqueous abstract of cinnamon in 125mg capsules
Cinnamon Extract: Purified aqueous abstract of cinnamon in 125mg capsules, which would be taken orally before each meal, for a total of 1,500mg/day for 6 months. | 23 |
| Placebo Arm Placebo capsules containing ground cereal.
Placebo: Placebo capsules containing ground cereal. | 22 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 12 | 16 |
Baseline characteristics
| Characteristic | Cinnamon Extract Arm | Placebo Arm | Total |
|---|---|---|---|
| Age, Continuous | 26.95 years | 27.86 years | 27.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 8 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 13 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment United States | 23 participants | 22 participants | 45 participants |
| Sex: Female, Male Female | 23 Participants | 22 Participants | 45 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 15 / 23 | 13 / 22 |
| serious Total, serious adverse events | 1 / 23 | 0 / 22 |
Outcome results
Primary
Number of Menses During the Six Month Study Period.
Ovulatory cycles will be confirmed by serum progesterone levels.
Time frame: Up to 6 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cinnamon Extract Arm | Number of Menses During the Six Month Study Period. | Baseline | .42 Number of menstrual cycles per month |
| Cinnamon Extract Arm | Number of Menses During the Six Month Study Period. | Study Period | .75 Number of menstrual cycles per month |
| Placebo Arm | Number of Menses During the Six Month Study Period. | Baseline | .42 Number of menstrual cycles per month |
| Placebo Arm | Number of Menses During the Six Month Study Period. | Study Period | .25 Number of menstrual cycles per month |
Secondary
Change in Glucose Response
Change in Glucose Response - area under the curve (AUC), trapezoidal method - in overweight patients with PCOS between baseline and after 6 months of daily cinnamon compared to the corresponding change in patient receiving 6 months of placebo. Fasting blood samples were drawn followed by a 2 hour glucose tolerance test with blood draws at 30, 60, and 120min post glucose ingestion.
Time frame: Baseline and 6 Months - fasting bloods, followed by glucose tolerance test with draws at 30, 60, and 120 minutes post glucose ingestion
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cinnamon Extract Arm | Change in Glucose Response | Glucose Response (Area under curve) - Baseline | 16,485 mg/dL*min |
| Cinnamon Extract Arm | Change in Glucose Response | Glucose Response (Area under curve) - 6 months | 16,515 mg/dL*min |
| Placebo Arm | Change in Glucose Response | Glucose Response (Area under curve) - Baseline | 13,298 mg/dL*min |
| Placebo Arm | Change in Glucose Response | Glucose Response (Area under curve) - 6 months | 15,420 mg/dL*min |
Secondary
Change in Insulin Resistance
The changes in insulin resistance parameters in overweight patients with PCOS between baseline and after 6 months of daily cinnamon compared to the corresponding change in patients receiving 6 months of placebo. Higher values of insulin resistance represent a worse outcome. A higher value Homeostasis Model of Insulin Resistance indicates more insulin resistance so higher values are worse outcomes (a score of \>2 is considered healthy for adults with scores \>5 being considered severe insulin resistance). For the Quant. Insulin Sensitivity Check Index, a lower value indicates more insulin resistance so lower values are worse outcomes (values can range from .45, which is considered normal in health individuals and .30, which is characteristic of diabetes).
Time frame: Baseline and 6 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cinnamon Extract Arm | Change in Insulin Resistance | Homeostasis Model of Insulin Resistance - Baseline | 2.3 Insulin sensitivity indices |
| Cinnamon Extract Arm | Change in Insulin Resistance | Homeostasis Model of Insulin Resistance - 6 months | 2.5 Insulin sensitivity indices |
| Cinnamon Extract Arm | Change in Insulin Resistance | Quant. Insulin Sensitivity Check Index - Baseline | .34 Insulin sensitivity indices |
| Cinnamon Extract Arm | Change in Insulin Resistance | Quant. Insulin Sensitivity Check Index - 6 months | .33 Insulin sensitivity indices |
| Placebo Arm | Change in Insulin Resistance | Quant. Insulin Sensitivity Check Index - 6 months | .37 Insulin sensitivity indices |
| Placebo Arm | Change in Insulin Resistance | Homeostasis Model of Insulin Resistance - Baseline | 1.8 Insulin sensitivity indices |
| Placebo Arm | Change in Insulin Resistance | Quant. Insulin Sensitivity Check Index - Baseline | .35 Insulin sensitivity indices |
| Placebo Arm | Change in Insulin Resistance | Homeostasis Model of Insulin Resistance - 6 months | 1.2 Insulin sensitivity indices |