Clinical trial NCT03844958: Effect of Red Furu Consumption on Serum Vitamin B12 and Homocysteine Concentration In Healthy Young Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Red furu
Metabolism
Randomized
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2019-02-19
Enrollment: 23
Sex: ALL
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will apply the parallel method and volunteers will be randomized into two groups.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 20-39 Years
* All Races

Exclusion Criteria:

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

Primary outcomes:
measure: Serum Vitamin B12
timeFrame: 0-24-72 Hours
measure: Serum Homocysteine
timeFrame: 0-24-72 Hours
Secondary outcomes:
measure: Serum Folate
timeFrame: 0-24-72 Hours
measure: Serum Iron
timeFrame: 0-24-72 Hours
measure: Serum Ferritin
timeFrame: 0-24-72 Hours
measure: Glucose
timeFrame: 0-24-72 Hours
measure: Total cholesterol
timeFrame: 0-24-72 Hours
measure: Triglyceride
timeFrame: 0-24-72 Hours
measure: High-density cholesterol
timeFrame: 0-24-72 Hours
measure: Low-density cholesterol
timeFrame: 0-24-72 Hours
Other outcomes:
measure: Normal Dietary Nutrient Intake
timeFrame: 0-24-72 Hours
Locations:
city: Hangzhou
country: China
facility: Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang University
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Duo Li, Doctor
role: STUDY_DIRECTOR
References:
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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.
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.