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

Study Overview
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Other: Red Furu
* Other: Tofu


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study will apply the parallel method and volunteers will be randomized into two groups.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Red Furu<br>Volunteer was randomized into group red furu | Other: Red Furu<br>* 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<br>Other: Tofu<br>* 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<br>|
| Experimental: Fresh Tofu<br>Volunteer was randomized into group tofu | Other: Red Furu<br>* 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<br>Other: Tofu<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Red furu, Metabolism, Randomized