Insulin ResistanceNCT02068144
The Effect of Cranberry Extract Supplementation on Cardiovascular Risk Factors in Obese, Insulin Resistant Humans
A study testing Cranberry Extract in people with Insulin Resistance and Atherosclerosis, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The purpose of this study is to determine the health benefits of cranberry extract in people who are at risk for diabetes and heart problems. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Atherosclerosis
- What is being tested?
- Cranberry Extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to 11 Jul 2018
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are 20 years of age or older
- Not being treated with diabetes medication. However, if you are taking Metformin for pre-diabetes and are willing to stop taking the medication 2 weeks before and during the study that is ok. We will request clearance from your prescribing physician prior to stopping metformin and enrolling in the study.
- Have a blood sugar of 100-125 mg/dL (fasting) or 140-199 mg/dL after a 2 hour glucose tolerance test (determined by tests done at the screening visit)
- Have a fasting insulin more than or equal to 5 µIU/ml (determined by tests done at the screening visit)
- Have a Body Mass Index (BMI) ≥ 30 and ≤ 45.
Who cannot join
- Have a prior history of type 2 diabetes
- Are pregnant or breastfeeding.
- Are a woman able to have children and are not using birth control (i.e. barrier method, intrauterine and cervical devices, birth control pills, hormonal injections (Depo Provera® ), condoms with spermicidal gel or foam, contraceptive patch (Ortho Evra), diaphragm, or abstinence), or have had a tubal ligation or hysterectomy, or not at least 2 years past menopause.
- All women able to have children will have a pregnancy test at the screening visit. If you become pregnant during the study, you will be dropped from the study.
- Have type 1 diabetes.
- Are taking steroids (except topical or inhaled steroids).
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- Other medications that may affect your blood sugar (i.e. certain blood pressure medications) are acceptable if the dose has not changed in the previous 6 months and the dose will not change during the study.
- Have a history or evidence of stomach or intestinal problems, e.g. irritable bowel syndrome; inflammatory bowel disease; ulcerative colitis or Crohn's disease; diverticulosis or diverticulitis; narrowing of the intestines, partial or complete removal of the stomach or small bowel; autonomic neuropathy consisting of difficulty swallowing; delayed stomach emptying or diarrhea; chronic, severe constipation; stomach or colon ulcers, or GI bleeding.
- Use laxatives or cathartics on a chronic basis.
- Take medications known to damage the kidneys, such as certain antibiotics, methicillin, and cyclosporin.
- Have any evidence of kidney disease.
- Have significant heart problems and/or history (within the last 6 months) of significant heart problems.
- Have evidence within the previous 6 months of liver disease such as hepatitis; jaundice; cirrhosis.
- Have clinically significant lung, neurologic, blood-related, immune system-related, cancer-related or metabolic disease.
- Have had a recurrence of cancer within the past five years, other than treated basal cell carcinoma.
- Are planning surgery during the study period.
- Have a history of substance abuse or alcoholism within the past 5 years, or significant psychiatric disorder that would interfere with your ability to complete the study.
- Have donated blood during the month before entering the study or are planning to donate blood during the study.
- Have participated in other studies using a research medication during the previous 3 months.
- Are currently smoking or have smoked within the past 6 months.
- No smoking will be allowed during the study.
- Have had a fluctuation in body weight >5% in the previous 2 months.
- Are taking prescription or over-the-counter medication for weight loss.
- Are taking weight loss or herbal supplements.
- Are taking prescription or over-the-counter anti-inflammatory medications (such as naproxen, aspirin, ibuprofen).
- Are allergic to cranberries
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: The Effect of Daily Dietary Supplementation With Cranberry Extract on Modulation of Cardiovascular Risk Factors in Obese, Insulin Resistant Human Subjects
The purpose of this study is to determine the health benefits of cranberry extract in people who are at risk for diabetes and heart problems.
Read the detailed description
This study will be a double-blinded, randomized, placebo-controlled, pilot study in which subjects with pre-diabetes will be randomized to receive either placebo or Cranberry extract for a total of 8 weeks of treatment. Each subject will continue on the same dosage of cranberry extract or matching placebo for the entire duration of treatment. Comparisons for insulin sensitivity, endothelial function, and markers of inflmmation and oxidative stress will be made between the 2 groups pre and post intervention.
- Conditions
- Insulin Resistance, Atherosclerosis
- Being tested
- Cranberry Extract, Placebo
- Keywords
- Cranberry Extract
- Medical subject headings
- Insulin Resistance, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranberry ExtractDietary supplement
Participants will drink one 15.2 oz bottle of Cranberry Extract beverage daily for 8 weeks.
PlaceboOther
Participants will drink one 15.2oz bottle of placebo beverage daily for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Cranberry Extract | Experimental | Cranberry Extract in a 15.2oz beverage daily for 8 weeks Receives: Dietary Supplement: Cranberry Extract |
| Placebo | Placebo comparator | Placebo 15.2oz beverage daily for 8 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Hyperinsulinemic-Euglycemic clamp at week 8
Insulin sensitivity is tested using a 120 mU/m2 hyperinsulinemic-euglycemic clamp at 100mg/dL glucose over 2 hours at weeks 0 and 8
Measured: 8 weeks +/- 2 days
Secondary outcomes (17)
Change from baseline in endothelial function at week 7
Endothelial function by peripheral arterial tone (PAT) with an endo-PAT device prior to week 0 and week 7 as a surrogate measure of atherosclerosis.
Measured: 8 weeks +/- 2 days
Change from baseline in Indirect Calorimetry at week 8
Resting metabolic rate via indirect calorimetry will be measured using a Deltatrac II Metabolic cart at week 0 and week 8 as part of the hyperinsulinemic euglycemic clamp.
Measured: 8 weeks +/- 2 days
Change from screening to week 8 in lipid profile
A comprehensive metabolic profile (CHEM 15) will be obtained at screening and then at week 8.
Measured: 10 weeks +/- 2 days
Change in body weight from baseline to week 8
Body weight will be assessed at baseline and week 8.
Measured: 8 weeks +/- 2 days
Change from screening to week 7 in oral glucose tolerance test (OGTT)
A 2 hr OGTT will be performed prior to week 0 and at week 7
Measured: 8 weeks +/- 2 days
Change in nitric oxide level at baseline and week 8
Levels of nitric oxide will be assessed at baseline and after 8 weeks of intervention
Measured: 8 weeks +/- 2 days
Change in endothelin 1 level at baseline and week 8
Levels of endothelin 1 will be assessed at baseline and after 8 weeks of intervention
Measured: 8 weeks +/- 2 days
Change in oxidized LDL level at baseline and week 8
Levels of oxidized LDL will be assessed at baseline and after 8 weeks of intervention
Measured: 8 weeks +/- 2 days
Change in LOX-1 (Lectin-like oxidized low density lipoprotein-1) at baseline and week 8
Levels of LOX-1 (Lectin-like oxidized low density lipoprotein-1) will be assessed at baseline and after 8 weeks of intervention
Measured: 8 weeks +/- 2 days
Change in 8-isoprostanes at baseline and week 8
Levels of 8-isoprostanes will be assessed at baseline and after 8 weeks of intervention
Measured: 8 weeks +/- 2 days
Change in malondialdehyde at baseline and week 8
Levels of malondialdehyde will be assessed at baseline and after 8 weeks of intervention
Measured: 8 weeks +/- 2 days
Change in advanced glycation end products at baseline and week 8
Levels of advanced glycation end products will be assessed at baseline and after 8 weeks of intervention
Measured: 8 weeks +/- 2 days
Change in Apo A1 at baseline and week 8
Levels of Apo A1 will be assessed at baseline and after 8 weeks of intervention
Measured: 8 weeks +/- 2 days
Change in Paraoxonase at baseline and week 8
Levels of Paraoxonase will be assessed at baseline and after 8 weeks of intervention
Measured: 8 weeks +/- 2 days
Change in Adiponectin at baseline and week 8
Levels of Adiponectin will be assessed at baseline and after 8 weeks of intervention
Measured: 8 weeks +/- 2 days
Change in C-reactive protein (CRP) at baseline and week 8
Levels of C-reactive protein (CRP) will be assessed at baseline and after 8 weeks of intervention
Measured: 8 weeks +/- 2 days
Change in TNFα at baseline and week 8
Levels of TNFα will be assessed at baseline and after 8 weeks of intervention
Measured: 8 weeks +/- 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completion2 Jun 2016
- Study completion11 Jul 2018
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ocean Spray, Inc.
- Responsible party
- Principal investigator, Daniel Hsia, Pennington Biomedical Research Center
- Investigators
- Daniel Hsia, MD, Principal investigator, Principal and Medical Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068144
- Sponsor's protocol ID
- PBRC 2013-047
- Status last verified
- Aug 2018
- First submitted
- 18 Feb 2014
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Daily Dietary Supplementation With Cranberry Extract on Modulation of Cardiovascular Risk Factors in Obese, Insulin Resistant Human Subjects
- ClinicalTrials.gov ID
- NCT02068144
- Acronym / sponsor ID
- PBRC 2013-047
- Conditions
- Insulin Resistance, Atherosclerosis
- Keywords
- Cranberry Extract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- Ocean Spray, Inc.
- Study start
- Feb 2014
- Primary completion
- 2 Jun 2016 (actual)
- Study completion
- 11 Jul 2018 (actual)
- First posted
- 21 Feb 2014 (estimated)
- 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.
The purpose of this study is to determine the health benefits of cranberry extract in people who are at risk for diabetes and heart problems.
Detailed description
This study will be a double-blinded, randomized, placebo-controlled, pilot study in which subjects with pre-diabetes will be randomized to receive either placebo or Cranberry extract for a total of 8 weeks of treatment. Each subject will continue on the same dosage of cranberry extract or matching placebo for the entire duration of treatment. Comparisons for insulin sensitivity, endothelial function, and markers of inflmmation and oxidative stress will be made between the 2 groups pre and post intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cranberry Extract | Experimental | Dietary Supplement: Cranberry ExtractCranberry Extract in a 15.2oz beverage daily for 8 weeks |
| Placebo | Placebo comparator | Other: PlaceboPlacebo 15.2oz beverage daily for 8 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Are 20 years of age or older
- Not being treated with diabetes medication. However, if you are taking Metformin for pre-diabetes and are willing to stop taking the medication 2 weeks before and during the study that is ok. We will request clearance from your prescribing physician prior to stopping metformin and enrolling in the study.
- Have a blood sugar of 100-125 mg/dL (fasting) or 140-199 mg/dL after a 2 hour glucose tolerance test (determined by tests done at the screening visit)
- Have a fasting insulin more than or equal to 5 µIU/ml (determined by tests done at the screening visit)
- Have a Body Mass Index (BMI) ≥ 30 and ≤ 45.
Key exclusion criteria (26 listed)
- Have a prior history of type 2 diabetes
- Are pregnant or breastfeeding.
- Are a woman able to have children and are not using birth control (i.e. barrier method, intrauterine and cervical devices, birth control pills, hormonal injections (Depo Provera® ), condoms with spermicidal gel or foam, contraceptive patch (Ortho Evra), diaphragm, or abstinence), or have had a tubal ligation or hysterectomy, or not at least 2 years past menopause.
- Have type 1 diabetes.
- Are taking steroids (except topical or inhaled steroids).
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 |
|---|---|---|
| Cranberry ExtractParticipants will drink one 15.2 oz bottle of Cranberry Extract beverage daily for 8 weeks. | Dietary supplement | Cranberry Extract |
| PlaceboParticipants will drink one 15.2oz bottle of placebo beverage daily for 8 weeks. | Other | Placebo |
Primary outcome
Change from baseline Hyperinsulinemic-Euglycemic clamp at week 8
Time frame: 8 weeks +/- 2 days
Insulin sensitivity is tested using a 120 mU/m2 hyperinsulinemic-euglycemic clamp at 100mg/dL glucose over 2 hours at weeks 0 and 8
17 secondary outcomes
Change from baseline in endothelial function at week 7
Time frame: 8 weeks +/- 2 days
Change from baseline in Indirect Calorimetry at week 8
Time frame: 8 weeks +/- 2 days
Change from screening to week 8 in lipid profile
Time frame: 10 weeks +/- 2 days
Change in body weight from baseline to week 8
Time frame: 8 weeks +/- 2 days
Change from screening to week 7 in oral glucose tolerance test (OGTT)
Time frame: 8 weeks +/- 2 days
Change in nitric oxide level at baseline and week 8
Time frame: 8 weeks +/- 2 days
Change in endothelin 1 level at baseline and week 8
Time frame: 8 weeks +/- 2 days
Change in oxidized LDL level at baseline and week 8
Time frame: 8 weeks +/- 2 days
Change in LOX-1 (Lectin-like oxidized low density lipoprotein-1) at baseline and week 8
Time frame: 8 weeks +/- 2 days
Change in 8-isoprostanes at baseline and week 8
Time frame: 8 weeks +/- 2 days
Change in malondialdehyde at baseline and week 8
Time frame: 8 weeks +/- 2 days
Change in advanced glycation end products at baseline and week 8
Time frame: 8 weeks +/- 2 days
Change in Apo A1 at baseline and week 8
Time frame: 8 weeks +/- 2 days
Change in Paraoxonase at baseline and week 8
Time frame: 8 weeks +/- 2 days
Change in Adiponectin at baseline and week 8
Time frame: 8 weeks +/- 2 days
Change in C-reactive protein (CRP) at baseline and week 8
Time frame: 8 weeks +/- 2 days
Change in TNFα at baseline and week 8
Time frame: 8 weeks +/- 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Individual participant dataSharing planned: No
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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.
Daniel Hsia, MD principal investigator
Principal and Medical Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cranberry Extract in people with Insulin Resistance and Atherosclerosis, run by Pennington Biomedical Research Center 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 5 inclusion and 26 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: finished, as of the sponsor's last update on 28 Aug 2018. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline Hyperinsulinemic-Euglycemic clamp at week 8 (time frame: 8 weeks +/- 2 days). 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 28 Aug 2018.