The Effect of Cranberry Extract Supplementation on Cardiovascular Risk Factors in Obese, Insulin Resistant Humans

August 27, 2018 updated by: Daniel Hsia, Pennington Biomedical Research Center

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Daniel Hsia, MD, Principal and Medical Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

June 2, 2016

Study Completion (Actual)

July 11, 2018

Study Registration Dates

First Submitted

February 18, 2014

First Submitted That Met QC Criteria

February 18, 2014

First Posted (Estimate)

February 21, 2014

Study Record Updates

Last Update Posted (Actual)

August 28, 2018

Last Update Submitted That Met QC Criteria

August 27, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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