NCT04119791

Brief Summary

In this study 24 adult males and adult females, with overall healthy condition, will consume approximately 30 grams of wild rice every day for 28 days. Cardiovascular risk factors will be assessed at the beginning and at the end of the study.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
21mo left

Started Nov 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress46%
Nov 2024Jan 2028

First Submitted

Initial submission to the registry

October 1, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 8, 2019

Completed
5.1 years until next milestone

Study Start

First participant enrolled

November 5, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2028

Expected
Last Updated

March 3, 2025

Status Verified

February 1, 2025

Enrollment Period

1.2 years

First QC Date

October 1, 2019

Last Update Submit

February 26, 2025

Conditions

Healthy DietHealthy

Outcome Measures

Primary Outcomes (2)

  • Wild rice alters gut microbiome.

    This study is designed to investigate the effects of wild rice consumption on gut microbiome diversity and population in volunteer healthy young adults.

    4 weeks

  • Changes in gut microbiome alters macronutrient metabolism.

    In this study, the investigators will establish whether changes in gut microbiome due to consumption of wild rice may result in altered macronutrient metabolism by studying plasma metabolomics.

    4 weeks

Secondary Outcomes (2)

  • Wild rice consumption improves blood lipid profile.

    4 weeks

  • Will rice consumption improves endothelial cell function.

    4 weeks

Study Arms (1)

Wild rice

EXPERIMENTAL

Participants will consume one serving of the test food containing wild rice every day over 28 days.

Other: wild rice

Interventions

wild riceOTHER

30 grams of wild rice in the form salad, snack bar and soup

Wild rice

Eligibility Criteria

Age20 Years - 40 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsAdult 20 - 40 years of age
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • Female
  • Both genders are healthy
  • years old

You may not qualify if:

  • Non-pregnant
  • Non-lactating
  • Non-smokers
  • Not obese (Body Mass Index (BMI) \< 30)
  • Not currently on any medications for cardiovascular, diabetes, and cancer diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Boniface Hospital Research Center Asper clinical

Winnipeg, Manitoba, R2H2A6, Canada

RECRUITING

Study Officials

  • Mohammed H Moghadasian, PhD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammed H Moghadasian, PhD

CONTACT

204-235-3934mmoghadasian@sbrc.ca

Khuong Le, Bsc

CONTACT

204-235-3954kle@sbrc.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 1, 2019

First Posted

October 8, 2019

Study Start

November 5, 2024

Primary Completion

January 30, 2026

Study Completion (Estimated)

January 30, 2028

Last Updated

March 3, 2025

Record last verified: 2025-02

Locations

CA(1)