NCT01398150

Brief Summary

The purpose of this study is to determine whether consuming a beverage made with cranberry polyphenols and proanthocyanidins is effective in modifying immune function by enhancing immune cell proliferation, cytokine production, and antioxidant capacity. If immune cell proliferation is improved, the subjects are expected to have fewer cold and flu symptoms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2009

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

Study Start

First participant enrolled

March 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2011

Completed
Last Updated

September 20, 2011

Status Verified

February 1, 2010

Enrollment Period

2 months

First QC Date

July 18, 2011

Last Update Submit

September 16, 2011

Conditions

Keywords

gamma delta T cellproliferationcytokine secretionimmune functionantioxidant status

Outcome Measures

Primary Outcomes (1)

  • Physiological modifications to immune cell function

    Proliferation of γδ-T cells when cultured ex vivo in autologous serum

    70 days

Secondary Outcomes (2)

  • Cold and flu symptoms

    70 days

  • Anti-inflammatory outcome

    70 days

Study Arms (2)

Sweetened Beverage

PLACEBO COMPARATOR

looks like and is given in the same way as the experimental treatment but contains no active ingredient

Dietary Supplement: Beverage made to look like the cranberry beverage

Cranberry Beverage

EXPERIMENTAL

15 ounce bottle of cranberry beverage consumed daily for 70 days

Dietary Supplement: Beverage made from cranberry compounds

Interventions

one 15 ounce bottle of beverage consumed daily

Sweetened Beverage

one 15 ounce bottle consumed daily for 70 days

Cranberry Beverage

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Health male or non-pregnant female
  • Between the ages of 21 and 50
  • BMI between 18 and 35

You may not qualify if:

  • High blood pressure define as 140/90
  • Ongoing or chronic illness or infection
  • On hypertensive medication, immunosuppressive drugs, antibiotics, or chronic use of NSAIDS
  • Taking plant-based dietary supplements, antioxidant supplements, or probiotics
  • Vegetarian or strict vegan
  • Consume more than 1 cup of tea (iced or hot) per day
  • Consumes more than 2 glasses of alcoholic beverages per day
  • Consume more than 7 fruits and vegetables per day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

449 Food Science and Human Nutrition Department

Gainesville, Florida, 32611, United States

Location

Related Publications (1)

  • Nantz MP, Rowe CA, Muller C, Creasy R, Colee J, Khoo C, Percival SS. Consumption of cranberry polyphenols enhances human gammadelta-T cell proliferation and reduces the number of symptoms associated with colds and influenza: a randomized, placebo-controlled intervention study. Nutr J. 2013 Dec 13;12:161. doi: 10.1186/1475-2891-12-161.

Study Officials

  • Susan S Percival, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 18, 2011

First Posted

July 20, 2011

Study Start

March 1, 2009

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

September 20, 2011

Record last verified: 2010-02

Locations