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SPI supplementation on some circulating biomarkers of CVD: glycemic control, lipid profiles and hs-CRP in type
2 Thai diabetic patients.
Subjects and Methods
Subjects
Thirty-six type 2 diabetes aged 35 years old and over who had FPG between 5.56-13.89 mmol/l with
used only sulfonylureas and/or biguanide as oral hypoglycemic agent with were recruited to participate in this
study. All subjects had blood pressure (BP) less than 160/100 mmHg, total cholesterol (TC) and TG level less than
6.21 mmol/l and 2.26 mmol/l, respectively and body mass index (BMI) between 18.5-29.9 kg/m
2
. They were not
currently on medicines, which affected the immune system or inflammation and any nutrition supplements or
herbal products and did not eat soy or soy product regularly. They were not vegetarians and free from chronic
diseases or conditions including liver disease, renal disease, cancer, immunodeficiency, infection, history of soy or
soy products allergy, malnutrition and surgery within 1 month before and during the study. The subjects were
randomly divided into 2 groups (SPI and control groups). The control group included 18 subjects (8 males and 10
females) and the SPI group included 18 subjects (7 males and 11 female).The experimental protocol was approved
by the Ethics Committee of Chulalongkorn University, and written informed consent was obtained from each
subject.
Study protocol
This is a quasi-experimental study. The subjects participated in a 10-week study with two
consecutive periods: a 4-week pre-experimental period followed by a 6-week experimental period.
Pre-Experimental Period
subjects received nutrition counseling to control blood glucose levels and
interviewed about personal information
.
Each subject was asked to maintain amount of energy intake, level of
physical activity, avoid taking soybean, soy products and legumes and take their regularly prescribed medications
throughout the study.
Experimental Period
after pre-experimental period, venous blood was obtained from each subject for
determining baseline of biomarkers of CVD including FPG, blood lipids and hs-CRP and anthropometric
measurements were also taken. Habitual diet was assessed by a 3-day food record prior to their experimental
period and during SPI supplementation period. The subjects in both groups were advised to maintain their regular
diets while each subjects in SPI group were received 42 packages of 30-g SPI/package and were instructed to
consume 1 package of 30-g SPI/day (containing 32 mg isoflavones) for 6 weeks by mixing with water, milk, soup
or other beverage and continued daily consuming the SPI until the end of week 6. At the end of study, venous
blood was drawn after 12 hour fast to determine biomarkers of CVD and anthropometric measurements were also
taken. Compliance was assessed by returned the all packages of SPI.
Statistical analysis
Categorical data were expressed as number and percentage of subjects. Continuous data were expressed
as mean ± standard deviation (SD). For comparison of the proportion of demographic data and subject
