NCT00970541

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2009

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2009

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

August 25, 2021

Status Verified

August 1, 2021

Enrollment Period

3.8 years

First QC Date

August 31, 2009

Last Update Submit

August 23, 2021

Conditions

Polycystic Ovary SyndromeInsulin Resistance

Keywords

CinnamonPCOSlow blood sugarInsulinGlucose

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity measured by the euglycemic hyperinsulinemic clamp

    6 months

Study Arms (2)

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

Cinnamon SupplementationDIETARY_SUPPLEMENT

1, 3, or 6g of cinnamon per day for 40 days

Also known as: The bark of Cinnamoni Cassae
Cinnamon Supplementation
Placebo (wheat flour)DIETARY_SUPPLEMENT

1, 3, or 6g of placebo per day for 40 days

Also known as: 500mg placebo (wheat flour) will be cnsumed before meals, three times per day.
Placebo

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Polycystic Ovary SyndromeInsulin ResistanceHypoglycemia

Interventions

Flour

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Leanne Redman, PhD

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Princiapal Investigator

Study Record Dates

First Submitted

August 31, 2009

First Posted

September 2, 2009

Study Start

August 1, 2009

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

August 25, 2021

Record last verified: 2021-08

Locations

US(1)