Effect of Cinnamon Extract on Insulin Resistance in Polyc... | NCT00970541

Studies
Effect of Cinnamon Extract on Insulin Resistance in Polycystic Ovary Syndrome

NCT00970541

Sponsor

Pennington Biomedical Research Center

Status

Terminated

Last Update Posted

Aug 25, 2021Actual

Enrollment

8Actual

Phase

Phase 1

Conditions

Polycystic Ovary Syndrome
Insulin Resistance

Interventions

Cinnamon Supplementation
Placebo (wheat flour)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Recruitment

Expanded Access Info

Start Date

Aug 2009Actual

Primary Completion Date

Jun 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Aug 31, 2009

First Submission Date that Met QC Criteria

Sep 1, 2009

First Posted Date

Sep 2, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 23, 2021

Last Update Posted Date

Aug 25, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cinnamon Supplementation	Active Comparator	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.	Dietary Supplement: Cinnamon Supplementation
Placebo	Placebo Comparator	A 500 mg placebo (wheat flour) will be consumed before meals, three times per day.	Dietary Supplement: Placebo (wheat flour)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cinnamon Supplementation	Dietary Supplement	1, 3, or 6g of cinnamon per day for 40 days	Cinnamon Supplementation

Measure	Description	Time Frame
Insulin sensitivity measured by the euglycemic hyperinsulinemic clamp		6 months

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Leanne Redman, PhD	Pennington Biomedical Research Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Pennington Biomedical Research Center		Baton Rouge	Louisiana	70808	United States

Condition Browse Module

MeSH Terms

ID	Term
D011085	Polycystic Ovary Syndrome
D007333	Insulin Resistance
D007003	Hypoglycemia

Ancestor Terms

ID	Term
D010048	Ovarian Cysts
D003560	Cysts
D009369	Neoplasms
D010049	Ovarian Diseases
D000291

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D019602	Food and Beverages