Effect of Red Furu Consumption on Serum Vitamin B12 and Homocysteine Concentration In Healthy Young Volunteers

NCT ID: NCT03844958

Last Updated: 2019-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-15

Study Completion Date

2017-06-19

Brief Summary

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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.

Detailed Description

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The study will apply the parallel study method and participants will be randomized into two groups. In the randomized controlled clinical trial, twenty-three healthy young volunteers (11 females and 12 males, aged 19-39 years) were recruited from Zhejiang University, China. They were randomly assigned to two groups of either red furu (n=11, 5 females and 6 males) or tofu (n=12, 6 females and 6 males). Volunteers consumed a provided meal, either 50 g of red furu or tofu with two slices of bread for 1 day breakfast meal. Volunteers also recorded their normal dietary intake during the 3 days trial period using provided self-report food diary. Fasting blood sample was drawn at 0h, 24h and 72h. Serum VB12, Hcy and other cardio-metabolic risk factors were measured by standard methods.

Test Meals:

Red Furu Group: 50 g of red furu with 2 slices of bread. Tofu Group: 50 g of plain tofu eaten with 2 slices of bread. Volunteers will refrain from consumption of fermented products 1 week prior to the study. Thereafter subject feed on control diet and intervention diet for 1 day. Volunteers' normal diets and test meals will be recorded on a self-administered questionnaire, followed by testing serum vitamin B12, Homocysteine and other biochemical parameters.

5-10 mL blood will be collected per session. Blood will be collected: 3 times (0h-24h-72h).Participants will be asked to fast for 10-12 hours prior to the blood draw.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study will apply the parallel method and volunteers will be randomized into two groups.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Red Furu

Volunteer was randomized into group red furu

Group Type EXPERIMENTAL

Red Furu

Intervention Type OTHER

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

Tofu

Intervention Type OTHER

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 Tofu

Volunteer was randomized into group tofu

Group Type EXPERIMENTAL

Red Furu

Intervention Type OTHER

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

Tofu

Intervention Type OTHER

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

Interventions

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Red Furu

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

Intervention Type OTHER

Tofu

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 20-39 Years
* All Races

Exclusion Criteria

* Taking antibiotics or vitamin B12 supplements within 1 month prior to enrollment
Minimum Eligible Age

20 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Duo li

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Duo Li, Doctor

Role: STUDY_DIRECTOR

Zhejiang University

Locations

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Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 11322691 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21436999 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25529671 (View on PubMed)

Other Identifiers

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Zhejiang University T.T

Identifier Type: -

Identifier Source: org_study_id

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