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| Name | Class |
|---|---|
| Integrity Nutraceuticals International | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cinnamon Extract Arm | Active Comparator | PCOS patients receiving abstract of cinnamon |
|
| Placebo Arm | Placebo Comparator | PCOS patients receiving placebo capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cinnamon Extract | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Menses During the Six Month Study Period. | Ovulatory cycles will be confirmed by serum progesterone levels. | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rogerio Lobo, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24813595 | Background | Kort DH, Lobo RA. Preliminary evidence that cinnamon improves menstrual cyclicity in women with polycystic ovary syndrome: a randomized controlled trial. Am J Obstet Gynecol. 2014 Nov;211(5):487.e1-6. doi: 10.1016/j.ajog.2014.05.009. Epub 2014 May 9. |
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Advertizing in newspaper beginning in August 2011
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Placebo Arm | Placebo capsules containing ground cereal. Placebo: Placebo capsules containing ground cereal. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Placebo Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Menses During the Six Month Study Period. | Ovulatory cycles will be confirmed by serum progesterone levels. | Posted | Median | Inter-Quartile Range | Number of menstrual cycles per month | Up to 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cinnamon Extract Arm | PCOS patients receiving extract of cinnamon 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Right leg swelling with pain | General disorders | Non-systematic Assessment | Hospitalized |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acid reflux | Gastrointestinal disorders | Non-systematic Assessment |
High percentage of patients lost to follow up
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roger A. Lobo M.D. | Columbia University, Department of OBGYN | 212-3056337 | ral35@columbia.edu |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D007333 | Insulin Resistance |
| D008599 | Menstruation Disturbances |
| D010048 | Ovarian Cysts |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
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| ID | Term |
|---|---|
| C546455 | cinnulin PF |
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|
| Placebo | Dietary Supplement | Placebo capsules containing ground cereal. |
|
| Baseline and 6 months |
| 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. | Baseline and 6 Months - fasting bloods, followed by glucose tolerance test with draws at 30, 60, and 120 minutes post glucose ingestion |
Placebo capsules containing ground cereal. Placebo: Placebo capsules containing ground cereal. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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). | Posted | Median | Inter-Quartile Range | Insulin sensitivity indices | Baseline and 6 months |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | mg/dL*min | Baseline and 6 Months - fasting bloods, followed by glucose tolerance test with draws at 30, 60, and 120 minutes post glucose ingestion |
|
|
|
| 1 |
| 23 |
| 15 |
| 23 |
| EG001 | Placebo Arm | PCOS patients receiving placebo capsules Placebo: Placebo capsules containing ground cereal. | 0 | 22 | 13 | 22 |
|
| Alopecia | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Anxiety | General disorders | Non-systematic Assessment |
|
| Back pain | General disorders | Non-systematic Assessment |
|
| Bodyache | General disorders | Non-systematic Assessment |
|
| Breast tenderness | General disorders | Non-systematic Assessment |
|
| Bruise on thigh | General disorders | Non-systematic Assessment |
|
| Bunion | General disorders | Non-systematic Assessment |
|
| Chest pain | General disorders | Non-systematic Assessment |
|
| Cold | General disorders | Non-systematic Assessment |
|
| Congestion | General disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Menstrual cramps | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Enlarged breast | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Feet swelling | General disorders | Non-systematic Assessment |
|
| Hands/palms swelling | General disorders | Non-systematic Assessment |
|
| Hangover | General disorders | Non-systematic Assessment |
|
| Headache | General disorders | Non-systematic Assessment |
|
| Heartburn | Gastrointestinal disorders | Non-systematic Assessment |
|
| Heightened sense of smell | General disorders | Non-systematic Assessment |
|
| Insomnia | General disorders | Non-systematic Assessment |
|
| Joint pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Lightheadedness | General disorders | Non-systematic Assessment |
|
| Migraine | General disorders | Non-systematic Assessment |
|
| Miscarriage | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Nasal congestion | General disorders | Non-systematic Assessment |
|
| Nausea | General disorders | Non-systematic Assessment |
|
| Overdose | General disorders | Non-systematic Assessment | 1 extra dose taken |
|
| Pain | General disorders | Non-systematic Assessment | Due to stomachache |
|
| Pink eye | Eye disorders | Non-systematic Assessment | Right eye affected |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Itchy rash | General disorders | Non-systematic Assessment | Due to bed bugs |
|
| Sleep problem | General disorders | Non-systematic Assessment |
|
| Sleepiness | General disorders | Non-systematic Assessment |
|
| Sore throat | General disorders | Non-systematic Assessment |
|
| Stomachache | General disorders | Non-systematic Assessment |
|
| Stomach cramps | General disorders | Non-systematic Assessment |
|
| Swelling of face (cheeks) | General disorders | Non-systematic Assessment |
|
| Stye in eye | Eye disorders | Non-systematic Assessment |
|
| Swelling of feet and hands | General disorders | Non-systematic Assessment |
|
| Swelling of lips | General disorders | Non-systematic Assessment |
|
| Swelling/puffiness of eye area | General disorders | Non-systematic Assessment |
|
| Throat/nasal congestion | General disorders | Non-systematic Assessment |
|
| Tiredness | General disorders | Non-systematic Assessment |
|
| Toothache | General disorders | Non-systematic Assessment |
|
| Trouble falling asleep | General disorders | Non-systematic Assessment |
|
| Upset stomach | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Quant. Insulin Sensitivity Check Index - Baseline |
|
| Quant. Insulin Sensitivity Check Index - 6 months |
|