NCT01295684

Brief Summary

Previous studies have shown that consumption of a low calorie cranberry beverage imparts a favorable impact on HDL cholesterol, LDL oxidation, and cell adhesion molecules in men. However, these studies were not well controlled. Thus, it is important to confirm these effects in a blinded, placebo-controlled feeding study. The investigators goal is to verify the cardioprotective effects of cranberries by conducting a dietary intervention trial with healthy subjects in a controlled environment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 14, 2011

Completed
Last Updated

February 14, 2011

Status Verified

February 1, 2011

Enrollment Period

3 months

First QC Date

May 11, 2010

Last Update Submit

February 11, 2011

Conditions

Cardiovascular Disease

Keywords

cranberrycardiovascularadhesionpolyphenol

Outcome Measures

Primary Outcomes (1)

  • Change in biomarkers of cardiovascular disease and polyphenol absorption

    A blood lipid panel will include plasma total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, Apo A-1, Apo A-II, Apo B, Lpa. Inflammatory markers (IL-6, IL-10, IL-1-alpha, CRP, TNF-alpha, fibrinogen, iCAM) will be determined by ELISA. Serum will be analyzed for polyphenol concentration.

    Days 1&2; Days 27&28; Days 55&56

Secondary Outcomes (3)

  • Change from baseline in systolic and diastolic blood pressure

    Days 1, 28, and 56

  • Change in urine metabolomics and adhesion analysis

    Days 1 & 56

  • Change in fecal microbiota

    Days 1 & 56

Study Arms (2)

placebo

PLACEBO COMPARATOR

Base diet supplemented with two 8 ounce servings of a color and flavor matched placebo beverage.

Other: Placebo

Cranberry Juice

EXPERIMENTAL

Base diet supplemented with two 8 ounce servings of low calorie cranberry juice per day.

Other: Cranberry juice

Interventions

Cranberry juiceOTHER

base diet supplemented with two 8 ounce servings of low calorie cranberry juice per day

Cranberry Juice
PlaceboOTHER

base diet supplemented with two 8 ounce servings of a color and flavor matched placebo beverage

placebo

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 65 years of age
  • BMI 20 to 38 kg/m2

You may not qualify if:

  • history of bariatric or certain other surgeries related to weight control
  • kidney disease, liver disease, certain cancers, gout, hyperthyroidism, untreated or unstable hypothyroidism, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes
  • Type 2 diabetes or use of glucose-lowering medication
  • Have a fasting blood sugar greater than 126 mg/dL
  • LDL-cholesterol less than 130 mg/dL
  • fasting triglycerides greater than 300 mg/dL
  • use of cholesterol-lowering medication or supplements
  • use of blood pressure-lowering medication
  • smoking or use of other tobacco products (within 6 months prior to the start of the study)
  • unwillingness to abstain from vitamin, mineral, and herbal supplements for 2 weeks prior to the study and during the study
  • use antibiotics during the study,or for 3 weeks prior to starting the study.
  • history of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
  • weight loss of \>/= 10% of your body weight within the last 12 months or plan to initiate a weight loss program during the next 10 months
  • inability to eat cranberries
  • inability or unwillingness to give informed consent or communicate with study staff
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USDA's Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

Location

Related Publications (1)

  • Novotny JA, Baer DJ, Khoo C, Gebauer SK, Charron CS. Cranberry juice consumption lowers markers of cardiometabolic risk, including blood pressure and circulating C-reactive protein, triglyceride, and glucose concentrations in adults. J Nutr. 2015 Jun;145(6):1185-93. doi: 10.3945/jn.114.203190. Epub 2015 Apr 22.

    PMID: 25904733DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesTissue Adhesions

Condition Hierarchy (Ancestors)

CicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Janet Novotny, Ph. D.

    USDA Beltsville Human Nutrition Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

May 11, 2010

First Posted

February 14, 2011

Study Start

September 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

February 14, 2011

Record last verified: 2011-02

Locations

US(1)