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NCT Number: NCT03844958

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

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.

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Key information

Conditions

Age range

20 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhejiang University, Hangzhou, Zhejiang, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 20-39 Years
  • All Races

Exclusion criteria

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

Treatment and study plan

Red Furu

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

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

Primary outcomes

  1. Serum Vitamin B12

    Time frame: 0-24-72 Hours

    Serum vitamin B12 concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd

  2. Serum Homocysteine

    Time frame: 0-24-72 Hours

    Serum homocysteine concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd

Secondary outcomes

  1. Serum Folate

    Time frame: 0-24-72 Hours

    Serum folate concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd

  2. Serum Iron

    Time frame: 0-24-72 Hours

    Serum iron concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd

  3. Serum Ferritin

    Time frame: 0-24-72 Hours

    Serum ferritin concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd

  4. Glucose

    Time frame: 0-24-72 Hours

    Serum glucose concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd

  5. Total cholesterol

    Time frame: 0-24-72 Hours

    Serum total cholesterol concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd

  6. Triglyceride

    Time frame: 0-24-72 Hours

    Triglyceride concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd

  7. High-density cholesterol

    Time frame: 0-24-72 Hours

    High-density cholesterol concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd

  8. Low-density cholesterol

    Time frame: 0-24-72 Hours

    Low-density cholesterol concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd

Other outcomes

  1. Normal Dietary Nutrient Intake

    Time frame: 0-24-72 Hours

    Calculated at Zhejiang University by the researcher using the Chinese Food Software

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 19, 2019
Registry last updated
Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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