Insulin ResistanceNCT04139694
Improving Insulin Resistance in Gynecological Cancer Patients
A study testing Food plan with cinnamon supplementation and Food plan without cinnamon supplementation in people with Insulin Resistance, run by Woman's at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- Food plan with cinnamon supplementation and Food plan without cinnamon supplementation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2020to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- no previous diagnosis of diabetes
- no other cancer diagnosis (excluding skin)
- no chronic use of medication(s) interfering with glucose metabolism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Insulin Resistance in Gynecological Cancer Patients Post Treatment Using Integrative and Functional Food Plan With or Without Cinnamon Supplementation
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.
- Conditions
- Insulin Resistance
- Being tested
- Food plan with cinnamon supplementation, Food plan without cinnamon supplementation
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food plan with cinnamon supplementationDietary supplement
Also called Gaia Herbs Cinnamon Bark
cinnamon twice daily plus follow Cardiometabolic diet
Food plan without cinnamon supplementationBehavioural
Cardiometabolic diet only
| Study group | Role | What they receive |
|---|---|---|
| Cinnamon with Food Plan | Experimental | Group of ladies who will undergo testing, receive dietary intervention, and take cinnamon supplements. Receives: Dietary Supplement: Food plan with cinnamon supplementation |
| Food Plan Only | Active comparator | Group of ladies who will undergo testing, receive dietary intervention, but will not get cinnamon supplements. Receives: Behavioral: Food plan without cinnamon supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in mean glucose concentration
To determine whether the addition of cinnamon to the implementation of an integrative and functional (IF) food plan will show a difference of 10 mg% in the mean glucose concentration measured when comparing the baseline and 24 week Oral Glucose Tolerance Test (OGTT) glucose levels.
Measured: 24 weeks
Secondary outcomes (3)
body mass index (BMI)
To determine whether the addition of cinnamon to the implementation of an IF food plan will improve BMI more than just dietary intervention alone. BMI will be calculated by dividing the participant's weight by her height squared.
Measured: 24 weeks
body composition
To determine whether the addition of cinnamon to the implementation of an IF food plan will improve the ratio of fat mass to fat free mass more than just dietary intervention alone. We will measure using a Fit3D scanner that uses infrared cameras to estimate fat mass and fat free mass.
Measured: 24 weeks
glucose tolerance
To determine whether the addition of cinnamon to the implementation of an IF food plan will improve glucose tolerance levels more than just dietary intervention alone. It will be measured using the results of the baseline and final 2-hour Oral Glucose Tolerance Test which measures glucose and insulin at 4 time points.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start16 Mar 2020
- Primary completionMay 2020 (estimated)
- Study completionJul 2020 (estimated)
Why it stopped: unable to procure supplement for clinical trial use
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woman's
- Sponsor type
- University, hospital or other
- Collaborators
- Woman's Hospital, Louisiana, Dietitians in Integrative and Functional Medicine DPG
- Responsible party
- Principal investigator, Brooke Schoonenberg, Woman's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04139694
- Sponsor's protocol ID
- RP-19-002
- Status last verified
- May 2020
- First submitted
- 10 Oct 2019
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Insulin Resistance in Gynecological Cancer Patients Post Treatment Using Integrative and Functional Food Plan With or Without Cinnamon Supplementation
- ClinicalTrials.gov ID
- NCT04139694
- Acronym / sponsor ID
- RP-19-002
- Conditions
- Insulin Resistance
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unable to procure supplement for clinical trial use
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Woman'sUniversity, hospital or other
- Collaborators
- Woman's Hospital, Louisiana, Dietitians in Integrative and Functional Medicine DPG
- Study start
- 16 Mar 2020 (actual)
- Primary completion
- May 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 25 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cinnamon with Food Plan | Experimental | Dietary Supplement: Food plan with cinnamon supplementationGroup of ladies who will undergo testing, receive dietary intervention, and take cinnamon supplements. |
| Food Plan Only | Active comparator | Behavioral: Food plan without cinnamon supplementationGroup of ladies who will undergo testing, receive dietary intervention, but will not get cinnamon supplements. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- no previous diagnosis of diabetes
- no other cancer diagnosis (excluding skin)
- no chronic use of medication(s) interfering with glucose metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food plan with cinnamon supplementationAlso: Gaia Herbs Cinnamon Barkcinnamon twice daily plus follow Cardiometabolic diet | Dietary supplement | Cinnamon with Food Plan |
| Food plan without cinnamon supplementationCardiometabolic diet only | Behavioural | Food Plan Only |
Primary outcome
Improvement in mean glucose concentration
Time frame: 24 weeks
To determine whether the addition of cinnamon to the implementation of an integrative and functional (IF) food plan will show a difference of 10 mg% in the mean glucose concentration measured when comparing the baseline and 24 week Oral Glucose Tolerance Test (OGTT) glucose levels.
3 secondary outcomes
body mass index (BMI)
Time frame: 24 weeks
body composition
Time frame: 24 weeks
glucose tolerance
Time frame: 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food plan with cinnamon supplementation and Food plan without cinnamon supplementation in people with Insulin Resistance, run by Woman's at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in mean glucose concentration (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020.