NCT02860468

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable healthy

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

July 25, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 9, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

January 16, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2018

Completed
Last Updated

November 16, 2018

Status Verified

November 1, 2018

Enrollment Period

1.2 years

First QC Date

July 25, 2016

Last Update Submit

November 15, 2018

Conditions

Healthy

Outcome Measures

Primary Outcomes (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.

    up to 6 months

Secondary Outcomes (2)

  • Number of healthier microbial community in the stool sample after short-term (3 days) and long-term (21 days) cranberry juice consumption.

    3 days and 21 days

  • 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

    3 days and 21 days

Study Arms (2)

Cranberry juice consumption

EXPERIMENTAL

participants in this arm will be provided cranberry juice to consume for 21 days in total

Other: Cranberry juice

Placebo juice consumption

PLACEBO COMPARATOR

participants in this arm will be provided placebo juice to consume for 21 days in total

Other: Placebo juice

Interventions

Cranberry juiceOTHER

cranberry juice cocktail provided by Ocean Spray Cranberries, Inc.

Cranberry juice consumption
Placebo juiceOTHER

apple juice added with flavor and colorants provided by Ocean Spray Cranberries, Inc.

Placebo juice consumption

Eligibility Criteria

Age18 Years - 29 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Food Science and human nutrition department at University of Florida

Gainesville, Florida, 32611, United States

Location

Related Publications (3)

  • Jepson R, Craig J, Williams G. Cranberry products and prevention of urinary tract infections. JAMA. 2013 Oct 2;310(13):1395-6. doi: 10.1001/jama.2013.277509.

    PMID: 24084925BACKGROUND

  • Liu H, Garrett TJ, Tayyari F, Gu L. Profiling the metabolome changes caused by cranberry procyanidins in plasma of female rats using (1) H NMR and UHPLC-Q-Orbitrap-HRMS global metabolomics approaches. Mol Nutr Food Res. 2015 Nov;59(11):2107-18. doi: 10.1002/mnfr.201500236. Epub 2015 Sep 15.

    PMID: 26264887BACKGROUND

  • Ou K, Sarnoski P, Schneider KR, Song K, Khoo C, Gu L. Microbial catabolism of procyanidins by human gut microbiota. Mol Nutr Food Res. 2014 Nov;58(11):2196-205. doi: 10.1002/mnfr.201400243. Epub 2014 Aug 22.

    PMID: 25045165BACKGROUND

Study Officials

  • Liwei Gu, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 25, 2016

First Posted

August 9, 2016

Study Start

January 16, 2017

Primary Completion

March 25, 2018

Study Completion

November 15, 2018

Last Updated

November 16, 2018

Record last verified: 2018-11

Locations

US(1)