NCT01527617

Brief Summary

The objective of this randomized, double-blind, placebo-controlled, parallel-design clinical trial is to investigate the potential antioxidant benefits of a cranberry beverage. The investigators hypothesize the chronic consumption of this beverage will improve indices of oxidative stress, inflammation, endothelial function, and glucoregulation. The investigators also hypothesize that these benefits will be particularly evident following an oral glucose tolerance test.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 7, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

June 2, 2016

Status Verified

June 1, 2016

Enrollment Period

11 months

First QC Date

January 30, 2012

Last Update Submit

June 1, 2016

Conditions

Inflammation

Outcome Measures

Primary Outcomes (2)

  • Change in biomarkers of inflammation compared with placebo

    Baseline and 8 weeks

  • Change in biomarkers of oxidative stress compared with placebo.

    Baseline and 8 weeks

Study Arms (2)

Cranberry beverage

ACTIVE COMPARATOR
Other: Cranberry

Non-cranberry beverage

PLACEBO COMPARATOR
Other: Non-Cranberry beverage

Interventions

CranberryOTHER

beverage containing cranberry at a dose of 15.2 ounces per day for 56 days.

Cranberry beverage
Non-Cranberry beverageOTHER

Placebo Comparator - beverage absent cranberry at a dose of 15.2 ounces per day for 56 days.

Non-cranberry beverage

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men \& women, aged 30-70 years
  • BMI 27-34.9 kg/m2
  • waist:hip ratio \> 0.8 for women and \> 0.9 for men

You may not qualify if:

  • Cigarette smoking and/or nicotine replacement use within last 6 months
  • Individuals taking estrogen or testosterone
  • Use of cholesterol-lowering medications
  • Use of blood pressure-lowering medications
  • Regular use (\> 1x/wk) of any stomach acid-lowering medications or laxatives (including fiber supplements)
  • Cardiovascular (heart) disease
  • Gastrointestinal disease
  • Kidney disease
  • Endocrine disease: including diabetes, untreated thyroid disease
  • Rheumatoid arthritis
  • Immune deficiency conditions
  • Active treatment for any type of cancer, except basal cell carcinoma, within 1 year prior to study admission
  • Systolic blood pressure \> 139 mmHg and/or diastolic blood pressure \> 89 mmHg
  • Regular use of systemic steroids, oral or injectable
  • Regular daily intake of ≥ 2 alcoholic drinks
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, 02111, United States

Location

Washington State University

Pullman, Washington, 99164, United States

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2012

First Posted

February 7, 2012

Study Start

February 1, 2012

Primary Completion

January 1, 2013

Study Completion

February 1, 2013

Last Updated

June 2, 2016

Record last verified: 2016-06

Locations

US(2)