NCT04018066

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

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

June 28, 2019

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

November 10, 2021

Completed
Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

July 8, 2019

Results QC Date

July 29, 2021

Last Update Submit

December 4, 2025

Conditions

Mechanisms, Defense

Keywords

gut microbiomemetabolomedietary polyphenolsgrapenutrition

Outcome Measures

Primary Outcomes (1)

  • Gut Microbiota Composition

    Evaluate the effect of nutritional supplementation with GP-SPI on gut microbiota composition by 16S rRNA amplicon sequencing and analysis

    16S rRNA amplicon sequencing will be performed on samples collected at baseline (before intervention, day -5), after 5 days of SPI supplementation (day 0), and after 10 days of GP-SPI supplementation (day 10). Total time frame is 17 days.

Secondary Outcomes (7)

  • Comprehensive Metabolic Panel (CMP) Blood Test (ALP, AST, ALT)

    Samples will be analyzed within one week of blood collection

  • Comprehensive Metabolic Panel (CMP) Blood Test (Glucose, Blood Urea Nitrogen, Creatine, Calcium, Bilirubin Total)

    Samples will be analyzed within one week of blood collection

  • Comprehensive Metabolic Panel Blood Test (Anion Gap)

    Samples will be analyzed within one week of blood collection

  • Comprehensive Metabolic Panel (CMP) Blood Test (Sodium, Potassium, Chloride, Total Carbon Dioxide)

    Samples will be analyzed within one week of blood collection

  • Comprehensive Metabolic Panel (CMP) Blood Test (Protein, Albumin)

    Samples will be analyzed within one week of blood collection

  • +2 more secondary outcomes

Study Arms (1)

GP-SPI intervention

EXPERIMENTAL

20 g of GP-SPI taken twice per day for 10 days

Dietary Supplement: GP-SPI

Interventions

GP-SPIDIETARY_SUPPLEMENT

grape polyphenol-soy protein isolate complex (GP-SPI)

GP-SPI intervention

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • Adults between 18 and 35 years
  • BMI 18.5 -29.9
  • Have at least one bowel movement per day
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

You may not qualify if:

  • 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.
  • Cannot provide written informed consent.
  • Exposure to any experimental agent or procedure within 30 days of study.
  • Pregnancy or breast-feeding
  • Taking dietary supplements
  • Current smoker or have smoked within previous 6 months
  • Taking medications regularly (prescription, over the counter, supplements etc.)
  • Treated with antibiotics during the past 6 months
  • Have an allergy to soy or grapes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rutgers, The State University of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (1)

  • Mezhibovsky E, Wu G, Wu Y, Ning Z, Bacalia K, Sadangi S, Patel R, Poulev A, Duran RM, Macor M, Coyle S, Lam YY, Raskin I, Figeys D, Zhao L, Roopchand DE. Grape polyphenols reduce fasting glucose and increase hyocholic acid in healthy humans: a meta-omics study. NPJ Sci Food. 2025 May 27;9(1):87. doi: 10.1038/s41538-025-00443-6.

    PMID: 40425565RESULT

Related Links

Results Point of Contact

Title
Dr. Diana Roopchand, Study Investigator
Organization
Rutgers, The State University of New Jersey
roopchand@sebs.rutgers.edu
8489320248

Study Officials

  • Diana Roopchand, PhD

    Rutgers University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Longitudinal study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 8, 2019

First Posted

July 12, 2019

Study Start

June 28, 2019

Primary Completion

December 20, 2019

Study Completion

December 20, 2019

Last Updated

December 23, 2025

Results First Posted

November 10, 2021

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)