Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05290519 |
Other study ID # |
NTNU |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 1, 2022 |
Est. completion date |
December 31, 2022 |
Study information
Verified date |
March 2022 |
Source |
National Taiwan Normal University |
Contact |
Wan-Ju Yeh |
Phone |
886277496988 |
Email |
wandayeh[@]ntnu.edu.tw |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The investigators will try to evaluate the effects of substitution of dietary animal protein
by black soybean milk (400 mL x 2) per day on anthropocentric and metabolic parameters in
obese subjects.
Description:
According to the survey by the Ministry of Health and Welfare, the proportion of obese male
adolescents in Taiwan has been increasing year by year. Obesity is associated with chronic
low-grade inflammation. Obese people prefer to intake foods containing higher levels of
advanced glycation end products (AGEs). High intake of dietary AGEs (dAGEs) results in
abdominal obesity, and shows positive correlation with body mass index (BMI) and waist
circumference. When a large amount of AGEs accumulates in the body, inflammation usually
occurs. Therefore, reducing dAGEs intake prevents the incidence of obesity, chronic diseases
and aging. Black beans are high in protein. The black bean coats contain high level of
anthocyanins. Previous studies demonstrated the biological functions of anthocyanins on blood
lipid regulation, inflammation, and also inhibition of AGEs formation. Compared with meat
(beef, pork, lamb, chicken, and seafood), the plant protein source, soy milk, under the same
protein content showed significantly lower dAGE. In this study, the investigators will try to
eveluate the effects of substitution of dietary animal protein by black soybean milk (400 mL
x 2) per day on anthropocentric and metabolic parameters in obese subjects. This will be a
randomized crossover interventional trial for 16 weeks: 0 to 4 weeks will be run-in period, 4
to 8 weeks and 12 to 16 weeks will be the soy milk or meat intervention period, and the
between of two interventions (8 to 12 weeks) will be washout period. The body composition,
blood pressure and AGE level will be measured. The blood, urine and feces sample will be
collected for biochemical analysis and gut microbiome. The investigators expect the results
could support the promotion of plant protein as part of dietary protein source to improve
abnormal anthropometric and metabolic parameters in obese subjects.