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

Effect of Consuming Red Furu On Serum Vitamin B12, Homocysteine And Other Cardio-Metabolic Risk Factors In Healthy Young Volunteers: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Red Furu; Other: Tofu

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310058
      • Zhejiang University
    • Hangzhou, Zhejiang, China
      • Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 39 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 20-39 Years
• All Races

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Red Furu; Volunteer was randomized into group red furu	Other: 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; 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
Experimental: Fresh Tofu; Volunteer was randomized into group tofu	Other: 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Folate	Serum folate concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd	0-24-72 Hours
Serum Iron	Serum iron concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd	0-24-72 Hours
Serum Ferritin	Serum ferritin concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd	0-24-72 Hours
Glucose	Serum glucose concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd	0-24-72 Hours
Total cholesterol	Serum total cholesterol concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd	0-24-72 Hours
Triglyceride	Triglyceride concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd	0-24-72 Hours
High-density cholesterol	High-density cholesterol concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd	0-24-72 Hours
Low-density cholesterol	Low-density cholesterol concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd	0-24-72 Hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Normal Dietary Nutrient Intake	Calculated at Zhejiang University by the researcher using the Chinese Food Software	0-24-72 Hours

Collaborators and Investigators

• Sponsor: Zhejiang University
• Investigators: Study Director: Duo Li, Doctor, Zhejiang University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2017
• Primary Completion (Actual): June 17, 2017
• Study Completion (Actual): June 19, 2017

Study Registration Dates

• First Submitted: February 2, 2019
• First Submitted That Met QC Criteria: February 18, 2019
• First Posted (Actual): February 19, 2019

Study Record Updates

• Last Update Posted (Actual): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 22, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Randomized; Metabolism; Red furu
• Other Study ID Numbers: Zhejiang University T.T

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No