NCT03844958

Brief Summary

The aim of the present study is to investigate the effect of red furu (Chinese fermented soybean product) consumption on serum vitamin B12, Homocysteine concentration and other cardio-metabolic risk factors in healthy young volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

2 active sites

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 15, 2017

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2017

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2017

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 19, 2019

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

2 days

First QC Date

February 2, 2019

Last Update Submit

February 22, 2019

Conditions

Keywords

Red furuMetabolismRandomized

Outcome Measures

Primary Outcomes (2)

  • Serum Vitamin B12

    Serum vitamin B12 concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd

    0-24-72 Hours

  • Serum Homocysteine

    Serum homocysteine concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd

    0-24-72 Hours

Secondary Outcomes (8)

  • Serum Folate

    0-24-72 Hours

  • Serum Iron

    0-24-72 Hours

  • Serum Ferritin

    0-24-72 Hours

  • Glucose

    0-24-72 Hours

  • Total cholesterol

    0-24-72 Hours

  • +3 more secondary outcomes

Other Outcomes (1)

  • Normal Dietary Nutrient Intake

    0-24-72 Hours

Study Arms (2)

Red Furu

EXPERIMENTAL

Volunteer was randomized into group red furu

Other: Red FuruOther: Tofu

Fresh Tofu

EXPERIMENTAL

Volunteer was randomized into group tofu

Other: Red FuruOther: Tofu

Interventions

50 g red furu was consumed with 2 slices of plain bread for one-day 50 g Fresh tofu was consumed with 2 slices of plain bread for one-day

Fresh TofuRed Furu
TofuOTHER

50 g Fresh tofu was consumed with 2 slices of plain bread for one-day 50 g red furu was consumed with 2 slices of plain bread for one-day

Fresh TofuRed Furu

Eligibility Criteria

Age20 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Years
  • All Races

You may not qualify if:

  • Taking antibiotics or vitamin B12 supplements within 1 month prior to enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Zhejiang University

Hangzhou, Zhejiang, 310058, China

Location

Zhejiang University

Hangzhou, Zhejiang, China

Location

Related Publications (3)

  • Han BZ, Rombouts FM, Nout MJ. A Chinese fermented soybean food. Int J Food Microbiol. 2001 Apr 11;65(1-2):1-10. doi: 10.1016/s0168-1605(00)00523-7.

    PMID: 11322691BACKGROUND
  • Kwak CS, Lee MS, Oh SI, Park SC. Discovery of novel sources of vitamin b(12) in traditional korean foods from nutritional surveys of centenarians. Curr Gerontol Geriatr Res. 2010;2010:374897. doi: 10.1155/2010/374897. Epub 2011 Mar 8.

    PMID: 21436999BACKGROUND
  • Xu L, Du B, Xu B. A systematic, comparative study on the beneficial health components and antioxidant activities of commercially fermented soy products marketed in China. Food Chem. 2015 May 1;174:202-13. doi: 10.1016/j.foodchem.2014.11.014. Epub 2014 Nov 8.

    PMID: 25529671BACKGROUND

MeSH Terms

Interventions

Soy Foods

Intervention Hierarchy (Ancestors)

Fermented FoodsDiet, Food, and NutritionPhysiological PhenomenaVegetable ProductsVegetablesFoodFood and Beverages

Study Officials

  • Duo Li, Doctor

    Zhejiang University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study will apply the parallel method and volunteers will be randomized into two groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 2, 2019

First Posted

February 19, 2019

Study Start

June 15, 2017

Primary Completion

June 17, 2017

Study Completion

June 19, 2017

Last Updated

February 26, 2019

Record last verified: 2019-02

Locations