Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 12:02 AM
NCT ID:
NCT03844958
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.
Study:
NCT03844958
Study Brief:
Protocol Section:
NCT03844958