Improving Insulin Resistance in Gynecological Cancer Patients

NCT ID: NCT04139694

Last Updated: 2020-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-16

Study Completion Date

2020-07-31

Brief Summary

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This is a research study to see if the addition of cinnamon to a provided food plan would improve insulin resistance in gynecological cancer patients. One study suggests that patients with gynecological cancers are more likely to be insulin resistant and/or have higher levels of fasting insulin. The study will be 24 weeks in length.

Detailed Description

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Conditions

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Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cinnamon with Food Plan

Group of ladies who will undergo testing, receive dietary intervention, and take cinnamon supplements.

Group Type EXPERIMENTAL

Food plan with cinnamon supplementation

Intervention Type DIETARY_SUPPLEMENT

cinnamon twice daily plus follow Cardiometabolic diet

Food Plan Only

Group of ladies who will undergo testing, receive dietary intervention, but will not get cinnamon supplements.

Group Type ACTIVE_COMPARATOR

Food plan without cinnamon supplementation

Intervention Type BEHAVIORAL

Cardiometabolic diet only

Interventions

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Food plan with cinnamon supplementation

cinnamon twice daily plus follow Cardiometabolic diet

Intervention Type DIETARY_SUPPLEMENT

Food plan without cinnamon supplementation

Cardiometabolic diet only

Intervention Type BEHAVIORAL

Other Intervention Names

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Gaia Herbs Cinnamon Bark

Eligibility Criteria

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Inclusion Criteria

* previously diagnosed with gynecological cancer and has completed all surgical intervention, chemotherapy, and/or radiation at least 3 months prior to enrollment but not greater than 24 months
* post-menopausal
* BMI \> 25 but \< 40

Exclusion Criteria

* no previous diagnosis of diabetes
* no other cancer diagnosis (excluding skin)
* no chronic use of medication(s) interfering with glucose metabolism
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Woman's Hospital, Louisiana

OTHER

Sponsor Role collaborator

Dietitians in Integrative and Functional Medicine DPG

UNKNOWN

Sponsor Role collaborator

Woman's

OTHER

Sponsor Role lead

Responsible Party

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Brooke Schoonenberg

Nutrition Services Manager

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Woman's Hospital

Baton Rouge, Louisiana, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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RP-19-002

Identifier Type: -

Identifier Source: org_study_id

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