HealthyNCT03844958
Effect of Red Furu Consumption on Serum Vitamin B12 and Homocysteine Concentration In Healthy Young Volunteers
A study testing Red Furu and Tofu in people with Healthy, run by Zhejiang University at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 20 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Red Furu and Tofu
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesChina
- Study dates
- 15 Jun 2017to 19 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20-39 Years
- All Races
Who cannot join
- Taking antibiotics or vitamin B12 supplements within 1 month prior to enrollment
Trial locations and contacts
2 sites in 1 country.
China2 sites
Zhejiang University
Hangzhou, Zhejiang, 310058
Zhejiang University
Hangzhou, Zhejiang
About this study
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
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Red Furu, Tofu
- Keywords
- Red furu, Metabolism, Randomized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red FuruOther
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
TofuOther
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
| Study group | Role | What they receive |
|---|---|---|
| Red Furu | Experimental | Volunteer was randomized into group red furu Receives: Other: Red Furu; Other: Tofu |
| Fresh Tofu | Experimental | Volunteer was randomized into group tofu Receives: Other: Red Furu; Other: Tofu |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Vitamin B12
Serum vitamin B12 concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd
Measured: 0-24-72 Hours
Serum Homocysteine
Serum homocysteine concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd
Measured: 0-24-72 Hours
Secondary outcomes (8)
Serum Folate
Serum folate concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd
Measured: 0-24-72 Hours
Serum Iron
Serum iron concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd
Measured: 0-24-72 Hours
Serum Ferritin
Serum ferritin concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd
Measured: 0-24-72 Hours
Glucose
Serum glucose concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd
Measured: 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
Measured: 0-24-72 Hours
Triglyceride
Triglyceride concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd
Measured: 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
Measured: 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
Measured: 0-24-72 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start15 Jun 2017
- Primary completion17 Jun 2017
- Study completion19 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will apply the parallel method and volunteers will be randomized into two groups.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duo li, Zhejiang University
- Investigators
- Duo Li, Doctor, Study director, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844958
- Sponsor's protocol ID
- Zhejiang University T.T
- Status last verified
- Feb 2019
- First submitted
- 2 Feb 2019
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 11322691Kwak 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.
PubMed 21436999Xu 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.
PubMed 25529671
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03844958
- Acronym / sponsor ID
- Zhejiang University T.T
- Conditions
- Healthy
- Keywords
- Red furu, Metabolism, Randomized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 17 Jun 2017 (actual)
- Study completion
- 19 Jun 2017 (actual)
- First posted
- 19 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will apply the parallel method and volunteers will be randomized into two groups.
| Arm | Type | Receives |
|---|---|---|
| Red Furu | Experimental | Other: Red Furu, Other: TofuVolunteer was randomized into group red furu |
| Fresh Tofu | Experimental | Other: Red Furu, Other: TofuVolunteer was randomized into group tofu |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 20-39 Years
- All Races
Key exclusion criteria (1 listed)
- Taking antibiotics or vitamin B12 supplements within 1 month prior to enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red Furu50 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 | Fresh Tofu, Red Furu |
| Tofu50 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 | Other | Fresh Tofu, Red Furu |
Primary outcome
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
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
8 secondary outcomes
Serum Folate
Time frame: 0-24-72 Hours
Serum Iron
Time frame: 0-24-72 Hours
Serum Ferritin
Time frame: 0-24-72 Hours
Glucose
Time frame: 0-24-72 Hours
Total cholesterol
Time frame: 0-24-72 Hours
Triglyceride
Time frame: 0-24-72 Hours
High-density cholesterol
Time frame: 0-24-72 Hours
Low-density cholesterol
Time frame: 0-24-72 Hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Background: PubMed 11322691Han 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.
- Background: PubMed 21436999Kwak 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.
- Background: PubMed 25529671Xu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duo Li, Doctor study director
Zhejiang University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red Furu and Tofu in people with Healthy, run by Zhejiang University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Vitamin B12 (time frame: 0-24-72 Hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03844958, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.