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The Effect of Concord Grape Polyphenol-soy Protein Isolate Complex (GP-SPI) on Gut Microbiota

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ClinicalTrials.gov Identifier: NCT04018066
Recruitment Status : Recruiting
First Posted : July 12, 2019
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Diana Roopchand, Ph.D., Rutgers, The State University of New Jersey

Brief Summary:
The overall purpose of this study is to evaluate the effect of nutritional supplementation with a well-characterized preparation of Concord grape polyphenol-soy protein isolate (GP-SPI) on the composition of the gut microbiota.

Condition or disease Intervention/treatment Phase
Mechanisms, Defense Dietary Supplement: GP-SPI Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Longitudinal study
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effect of Concord Grape Polyphenol-soy Protein Isolate Complex (GP-SPI) on Gut Microbiota
Actual Study Start Date : June 28, 2019
Estimated Primary Completion Date : January 28, 2020
Estimated Study Completion Date : March 1, 2021

Arm Intervention/treatment
Experimental: GP-SPI intervention
20 g of GP-SPI taken twice per day for 10 days
Dietary Supplement: GP-SPI
grape polyphenol-soy protein isolate complex (GP-SPI)




Primary Outcome Measures :
  1. Gut microbiota composition [ Time Frame: De-identified samples will be processed and analyzed after all subjects complete the study and within 1 year. ]
    Evaluate the effect of nutritional supplementation with GP-SPI on gut microbiota composition by amplicon sequencing


Secondary Outcome Measures :
  1. Comprehensive metabolic panel (CMP) blood test [ Time Frame: Samples will be analyzed within one week of blood collection ]
    Evaluate the effect of GP-SPI on kidney and liver health/function via CMP blood tests

  2. Microbiome-wide association study [ Time Frame: De-identified samples will be processed and analyzed after all subjects complete the study and within 1 year. ]
    Collect fecal, blood, and urine samples for a microbiome-wide association study (MWAS)

  3. Data sharing [ Time Frame: Data will be deposited no later than within 1 year of the completion of the funded project period for the parent award or upon acceptance of the data for publication, or public disclosure of a submitted patent application ]
    Enter de-identified study results into microbiome and metabolome nationwide data sharing database



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy as assessed based on a medical evaluation including a comprehensive metabolic panel (CMP) test with values in normal range, medical history and not presently taking any medication
  2. Adults between 18 and 35 years
  3. BMI 18.5 -29.9
  4. Have at least one bowel movement per day
  5. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Exclusion Criteria:

  1. History/current cancer, rheumatoid arthritis immunologic, renal, hepatic, endocrine, neurologic or heart disease, hypertension, diabetes, GI dysfunction, or CMP test results showing values outside of normal range.
  2. Cannot provide written informed consent.
  3. Exposure to any experimental agent or procedure within 30 days of study.
  4. Pregnancy or breast-feeding
  5. Taking dietary supplements
  6. Current smoker or have smoked within previous 6 months
  7. Taking medications regularly (prescription, over the counter, supplements etc.)
  8. Treated with antibiotics during the past 6 months
  9. Have an allergy to soy or grapes

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): NCT04018066


Contacts
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Contact: Diana E Roopchand, PhD 805-272-5163 roopchand@sebs.rutgers.edu
Contact: Susette Coyle, RN, MSN 732-235-8142 coylesu@rwjms.rutgers.edu

Locations
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United States, New Jersey
Rutgers, The State University of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Diana Roopchand, PhD    848-932-0248    roopchand@sebs.rutgers.edu   
Contact: Susette Coyle, RN, MSN    732-235-8142    coylesu@rwjms.rutgers.edu   
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
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Principal Investigator: Diana Roopchand, PhD Rutgers University

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Responsible Party: Diana Roopchand, Ph.D., Assistant Professor, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT04018066     History of Changes
Other Study ID Numbers: Pro2018002579
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Diana Roopchand, Ph.D., Rutgers, The State University of New Jersey:
gut microbiome
metabolome
dietary polyphenols
grape
nutrition