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To Determine the Metabolomics and Microbiome Changes After Cranberry Juice Consumption Among Young Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02860468
Recruitment Status : Completed
First Posted : August 9, 2016
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief Summary:
The compliance of participants in cranberry related clinical trial is poor due to the bitterness and astringency of cranberry products. There is a pressing need for an effective approach to verify participant compliance. The PLS-DA (Partial Least Squares Discriminant Analysis) /OPLS-DA (Orthogonal Partial Least Squares Discriminant Analysis) models established from the investigator's previous study provide an opportunity to identify cranberry juice consumers. In this blinded, placebo-controlled, cross-over study, investigators hypothesize that the established statistical models of PLS-DA (Partial least squares discriminant analysis) /OPLS-DA (Orthogonal partial least squares discriminant analysis) can identify cranberry juice consumers and non-consumers by analyzing the metabolomic changes in blood and urine among young women. In order to further explore the function of cranberry, microbiome profile will also be compared between cranberry juice consumption and placebo consumption after long-term treatment. Another comparison of metabolomic changes between short-term treatment and long-term treatment will be made to further identify candidate biomarkers of cranberry consumption and explore the correlation between acute effects and chronic effects of cranberry.

Condition or disease Intervention/treatment Phase
Healthy Other: Cranberry juice Other: Placebo juice Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: To Determine the Metabolomics and Microbiome Changes After Cranberry Juice Consumption Among Young Women
Actual Study Start Date : January 16, 2017
Actual Primary Completion Date : March 25, 2018
Actual Study Completion Date : November 15, 2018

Arm Intervention/treatment
Experimental: Cranberry juice consumption
participants in this arm will be provided cranberry juice to consume for 21 days in total
Other: Cranberry juice
cranberry juice cocktail provided by Ocean Spray Cranberries, Inc.

Placebo Comparator: Placebo juice consumption
participants in this arm will be provided placebo juice to consume for 21 days in total
Other: Placebo juice
apple juice added with flavor and colorants provided by Ocean Spray Cranberries, Inc.




Primary Outcome Measures :
  1. The correct rate of identifying cranberry consumers and non-cranberry consumers by previously established multivariate statistical models of PLS-DA/OPLS-DA combined with UHPLC-Q-Orbitrap-HRMS. [ Time Frame: up to 6 months ]

Secondary Outcome Measures :
  1. Number of healthier microbial community in the stool sample after short-term (3 days) and long-term (21 days) cranberry juice consumption. [ Time Frame: 3 days and 21 days ]
  2. The change in quantity of endogenous and exogenous metabolites in blood/urine after 3-day consumption and 21-day consumption of cranberry juice comparing to baseline blood/urine sample [ Time Frame: 3 days and 21 days ]


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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy
  • Normal BMI (18.5-25)
  • Body weight ≥110 pounds

Exclusion Criteria:

  • Gastrointestinal disorders
  • Urological diseases
  • Metabolic disorders
  • Smokers
  • Pregnancy
  • Previous use of antibiotics or probiotics.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860468


Locations
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United States, Florida
Food Science and human nutrition department at University of Florida
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Liwei Gu, PhD University of Florida
Publications:
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02860468    
Other Study ID Numbers: IRB201601249
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No