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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03844958
• Other study ID #: Zhejiang University T.T
• Status: Completed
• Phase: N/A
• Start date: June 15, 2017
• Est. completion date: June 19, 2017

Study information

• Verified date: February 2019
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: June 19, 2017
• Est. primary completion date: June 17, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 39 Years

Eligibility

Inclusion Criteria:

• 20-39 Years

• All Races

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Healthy

Intervention

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
• 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

Locations

Country	Name	City	State
China	Zhejiang University	Hangzhou	Zhejiang
China	Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

References & 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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Normal Dietary Nutrient Intake	Calculated at Zhejiang University by the researcher using the Chinese Food Software	0-24-72 Hours
Primary	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
Primary	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	Serum Folate	Serum folate concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd	0-24-72 Hours
Secondary	Serum Iron	Serum iron concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd	0-24-72 Hours
Secondary	Serum Ferritin	Serum ferritin concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd	0-24-72 Hours
Secondary	Glucose	Serum glucose concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd	0-24-72 Hours
Secondary	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
Secondary	Triglyceride	Triglyceride concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd	0-24-72 Hours
Secondary	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
Secondary	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