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

NCT02068144 | Completed

• 1 other identifier: PBRC 2013-047
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insulin Resistance; Atherosclerosis

Keywords

Cranberry Extract

Outcome Measures

Primary Outcomes (1)

• 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

  8 weeks +/- 2 days

Secondary Outcomes (17)

• Change from baseline in endothelial function at week 7

  8 weeks +/- 2 days

• Change from baseline in Indirect Calorimetry at week 8

  8 weeks +/- 2 days

• Change from screening to week 8 in lipid profile

  10 weeks +/- 2 days

• Change in body weight from baseline to week 8

  8 weeks +/- 2 days

• Change from screening to week 7 in oral glucose tolerance test (OGTT)

  8 weeks +/- 2 days

Study Arms (2)

Cranberry Extract

EXPERIMENTAL

Cranberry Extract in a 15.2oz beverage daily for 8 weeks

Dietary Supplement: Cranberry Extract

Placebo

PLACEBO COMPARATOR

Placebo 15.2oz beverage daily for 8 weeks

Other: Placebo

Interventions

Cranberry Extract DIETARY_SUPPLEMENT

Participants will drink one 15.2 oz bottle of Cranberry Extract beverage daily for 8 weeks.

Cranberry Extract

Placebo OTHER

Participants will drink one 15.2oz bottle of placebo beverage daily for 8 weeks.

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• Ocean Spray, Inc.: collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Insulin Resistance; Atherosclerosis

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Daniel Hsia, MD

  Principal and Medical Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal and Medical Investigator

Study Record Dates

• First Submitted: February 18, 2014
• First Posted: February 21, 2014
• Study Start: February 1, 2014
• Primary Completion: June 2, 2016
• Study Completion: July 11, 2018
• Last Updated: August 28, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)