- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02068144
The Effect of Cranberry Extract Supplementation on Cardiovascular Risk Factors in Obese, Insulin Resistant Humans
The Effect of Daily Dietary Supplementation With Cranberry Extract on Modulation of Cardiovascular Risk Factors in Obese, Insulin Resistant Human Subjects
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70808
- Pennington Biomedical Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cranberry Extract
Cranberry Extract in a 15.2oz beverage daily for 8 weeks
|
Participants will drink one 15.2 oz bottle of Cranberry Extract beverage daily for 8 weeks.
|
Placebo Comparator: Placebo
Placebo 15.2oz beverage daily for 8 weeks
|
Participants will drink one 15.2oz
bottle of placebo beverage daily for 8 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
8 weeks +/- 2 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in endothelial function at week 7
Time Frame: 8 weeks +/- 2 days
|
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.
|
8 weeks +/- 2 days
|
Change from baseline in Indirect Calorimetry at week 8
Time Frame: 8 weeks +/- 2 days
|
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.
|
8 weeks +/- 2 days
|
Change from screening to week 8 in lipid profile
Time Frame: 10 weeks +/- 2 days
|
A comprehensive metabolic profile (CHEM 15) will be obtained at screening and then at week 8.
|
10 weeks +/- 2 days
|
Change in body weight from baseline to week 8
Time Frame: 8 weeks +/- 2 days
|
Body weight will be assessed at baseline and week 8.
|
8 weeks +/- 2 days
|
Change from screening to week 7 in oral glucose tolerance test (OGTT)
Time Frame: 8 weeks +/- 2 days
|
A 2 hr OGTT will be performed prior to week 0 and at week 7
|
8 weeks +/- 2 days
|
Change in nitric oxide level at baseline and week 8
Time Frame: 8 weeks +/- 2 days
|
Levels of nitric oxide will be assessed at baseline and after 8 weeks of intervention
|
8 weeks +/- 2 days
|
Change in endothelin 1 level at baseline and week 8
Time Frame: 8 weeks +/- 2 days
|
Levels of endothelin 1 will be assessed at baseline and after 8 weeks of intervention
|
8 weeks +/- 2 days
|
Change in oxidized LDL level at baseline and week 8
Time Frame: 8 weeks +/- 2 days
|
Levels of oxidized LDL will be assessed at baseline and after 8 weeks of intervention
|
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
|
Levels of LOX-1 (Lectin-like oxidized low density lipoprotein-1) will be assessed at baseline and after 8 weeks of intervention
|
8 weeks +/- 2 days
|
Change in 8-isoprostanes at baseline and week 8
Time Frame: 8 weeks +/- 2 days
|
Levels of 8-isoprostanes will be assessed at baseline and after 8 weeks of intervention
|
8 weeks +/- 2 days
|
Change in malondialdehyde at baseline and week 8
Time Frame: 8 weeks +/- 2 days
|
Levels of malondialdehyde will be assessed at baseline and after 8 weeks of intervention
|
8 weeks +/- 2 days
|
Change in advanced glycation end products at baseline and week 8
Time Frame: 8 weeks +/- 2 days
|
Levels of advanced glycation end products will be assessed at baseline and after 8 weeks of intervention
|
8 weeks +/- 2 days
|
Change in Apo A1 at baseline and week 8
Time Frame: 8 weeks +/- 2 days
|
Levels of Apo A1 will be assessed at baseline and after 8 weeks of intervention
|
8 weeks +/- 2 days
|
Change in Paraoxonase at baseline and week 8
Time Frame: 8 weeks +/- 2 days
|
Levels of Paraoxonase will be assessed at baseline and after 8 weeks of intervention
|
8 weeks +/- 2 days
|
Change in Adiponectin at baseline and week 8
Time Frame: 8 weeks +/- 2 days
|
Levels of Adiponectin will be assessed at baseline and after 8 weeks of intervention
|
8 weeks +/- 2 days
|
Change in C-reactive protein (CRP) at baseline and week 8
Time Frame: 8 weeks +/- 2 days
|
Levels of C-reactive protein (CRP) will be assessed at baseline and after 8 weeks of intervention
|
8 weeks +/- 2 days
|
Change in TNFα at baseline and week 8
Time Frame: 8 weeks +/- 2 days
|
Levels of TNFα will be assessed at baseline and after 8 weeks of intervention
|
8 weeks +/- 2 days
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Daniel Hsia, MD, Principal and Medical Investigator
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PBRC 2013-047
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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