Cinnamon Extract on Menstrual Cycles in PolyCystic Ovary Syndrome (PCOS)

NCT01483118 | Completed Phase 3 Results DMC

• 1 other identifier: AAAI1377
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome

Keywords

PCOS; Insulin resistance; Cinnamon extract; Irregular menstrual cycles; Ovarian cysts

Outcome Measures

Primary Outcomes (1)

• Number of Menses During the Six Month Study Period.

  Ovulatory cycles will be confirmed by serum progesterone levels.

  Up to 6 months

Secondary Outcomes (2)

• Change in Insulin Resistance

  Baseline and 6 months

• 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

Study Arms (2)

Cinnamon Extract Arm

ACTIVE COMPARATOR

PCOS patients receiving abstract of cinnamon

Drug: Cinnamon Extract

Placebo Arm

PLACEBO COMPARATOR

PCOS patients receiving placebo capsules

Dietary Supplement: Placebo

Interventions

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.

Also known as: Cinnulin PF

Cinnamon Extract Arm

Placebo DIETARY_SUPPLEMENT

Placebo capsules containing ground cereal.

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Rogerio A. Lobo: lead
• Integrity Nutraceuticals International: collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

• 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.

  PMID: 24813595 BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Insulin Resistance; Menstruation Disturbances; Ovarian Cysts

Interventions

cinnulin PF

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

High percentage of patients lost to follow up

Results Point of Contact

• Title: Roger A. Lobo M.D.
• Organization: Columbia University, Department of OBGYN

ral35@columbia.edu

212-3056337

Study Officials

• Rogerio Lobo, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: November 29, 2011
• First Posted: December 1, 2011
• Study Start: March 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: April 1, 2014
• Last Updated: October 3, 2017
• Results First Posted: August 2, 2017

Record last verified: 2017-06

Locations

US (1)