Know Cancer

or
forgot password

Phase 1 Study That Will Compare 12 Weeks of Supplementation With Cinnamon Extract on the Action of Insulin and Blood Sugar (Glucose) With 12 Weeks of Supplementation With a Placebo.


Phase 1
20 Years
40 Years
Not Enrolling
Female
Polycystic Ovary Syndrome, Insulin Resistance

Thank you

Trial Information

Phase 1 Study That Will Compare 12 Weeks of Supplementation With Cinnamon Extract on the Action of Insulin and Blood Sugar (Glucose) With 12 Weeks of Supplementation With a Placebo.


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Insulin sensitivity measured by the euglycemic hyperinsulinemic clamp

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Leanne Redman, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Pennington Biomedical Research Center

Authority:

United States: Institutional Review Board

Study ID:

Eccentric

NCT ID:

NCT00970541

Start Date:

August 2009

Completion Date:

June 2013

Related Keywords:

  • Polycystic Ovary Syndrome
  • Insulin Resistance
  • Cinnamon
  • PCOS
  • low blood sugar
  • Insulin
  • Glucose
  • Insulin Resistance
  • Polycystic Ovary Syndrome

Name

Location

Pennington Biomedical Research CenterBaton Rouge, Louisiana  70808