The goal of this intervention study is to evaluate the effect of soya-based dietary fiber beverage (SBB) in overweight adults. The main question it aims to answer is: Does the SBB effective in improving the weight and metabolic parameters among overweight adults? Overweight participants will be randomly assigned to intervention or control group for a defined intervention period. The intervention involved the consumption of the SBB beverage powder while allowing participants to maintain their usual meal portions. while the control group will be asked to continue their usual breakfast, lunch, and dinner meals during the study period. Clinical and biochemical parameters will be assessed at baseline and after the intervention period to evaluate potential metabolic changes. Anthropometric and body composition will be recorded. Assessments will include questionnaires related to food frequency (FFQ), food diary, physical activity (IPAQ), satiety and appetite, and defecation behavior.
Dietary fiber plays a crucial role in weight management by enhancing satiety, reducing caloric intake, and modulating gut microbiota. Among various fiber sources, soya- based dietary fiber (SBB) is of particular interest due to its combined benefits of soluble and insoluble fiber, plant-based proteins, and bioactive compounds. Studies have shown that soya proteins and isoflavones contribute to lipid metabolism, insulin sensitivity, and overall weight reduction. However, there is limited research on the direct impact of soya-based dietary fiber beverages (SBB) on weight loss and metabolic health outcomes. In this study, the investigators have already developed soya-based dietary fiber beverage (SBB) formulated with soymilk powder, apple mixture powder, and botanical powder. While the formulation has been completed, its efficacy in improving anthropometric parameters and metabolic profiles among overweight adults remains untested. Individuals who agree to participate in this study will be divided into two groups: the Control Group and the Intervention Group. The intervention involves consume two servings of the beverage at least 30 min before each breakfast and teatime every day for 12 weeks, while the control group will be asked to continue their usual breakfast, lunch, and dinner meals during the study period. Regular consumption of the SBB beverage over three months may lead to significant improvements in metabolic health, including a reduction in body weight, improved body composition, and enhanced satiety response. Additionally, participants are expected to show positive changes in dietary intake patterns, physical activity levels, and quality of life. Biomarker analysis will further assess the impact of the intervention on metabolic and inflammatory parameters.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
The intervention consume two servings of the beverage at least 30 min before each breakfast and teatime every day for 12 weeks. One serving is one sachet (53g) of beverage powder in 250 mL cold water. There was no strict portion control, and participants could continue their habitual eating patterns. The focus was on incorporating the SBB beverage as part of their daily diet without restricting overall food intake.
Health Campus, Universiti Sains Malaysia
Kubang Kerian, Kelantan, Malaysia
Change in weight (kg)
Changes in body weight (kg) from baseline to week 12
Time frame: Baseline, week 4, week 8 and week 12
Change in body fat percentage (%)
Change in body fat percentage (%) from baseline to week 12.
Time frame: Baseline, week 4, week 8 and week 12
Change in body mass index (BMI) kg/m^2
Changes in BMI (kg/m\^2) from baseline to week 12. Weight (kg) and height (m) will be measured and combined to report BMI in kg/m²
Time frame: Baseline, week 4, week 8 and week 12
Change in waist circumference (cm)
Change in waist circumference (cm) from baseline to week 12
Time frame: Baseline, week 4, week 8 and week 12
Change in hip circumference (cm)
Changes in hip circumference (cm) from baseline to week 12
Time frame: Baseline, week 4, week 8 and week 12
Change in body fat mass (kg)
Change in body fat mass (kg) from baseline to week 12.
Time frame: Baseline, week 4, week 8 and week 12
Change in body fat-free mass (kg)
Change in body fat-free mass (kg) from baseline to week 12.
Time frame: Baseline, week 4, week 8 and week 12
Change in visceral fat rating
Change in visceral fat rating from baseline to week 12. Visceral Fat Rating from 1 to 12: Indicates a healthy level of visceral fat. Visceral Fat Rating from 13 to 59: Indicates an excess level of visceral fat.
Time frame: Baseline, week 4, week 8 and week 12
Change in muscle mass (kg)
Change in muscle mass (kg) from baseline to week 12.
Time frame: Baseline, week 4, week 8 and week 12
Change in blood pressure (mmHg)
Change in systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) from baseline to week 12.
Time frame: Baseline, week 4, week 8 and week 12
Change in total cholesterol (mg/dL)
Change in total cholesterol (mg/dL) from baseline to week 12
Time frame: Baseline and week 12
Change in low-density lipoprotein (LDL) (mg/dL)
Change in low-density lipoprotein (LDL) (mg/dL) from baseline to week 12
Time frame: baseline and week 12
Change in high-density lipoprotein (HDL) (mg/dL)
Change in high-density lipoprotein (HDL) (mg/dL) from baseline to week 12
Time frame: Baseline and week 12
Change in triglycerides (mg/dL)
Change in triglycerides (mg/dL) from baseline to week 12
Time frame: Baseline and week 12
Change in total protein (g/L)
Change in total protein (g/L) from baseline to week 12
Time frame: Baseline and week 12
Change in albumin (g/L)
Change in albumin (g/L) from baseline to week 12
Time frame: Baseline and week 12
Change in bilirubin (µmol/L)
Change in bilirubin (µmol/L) from baseline to week 12
Time frame: Baseline and week 12
Change in alkaline phosphatase (ALP) (U/L)
Change in alkaline phosphatase (ALP) (U/L) from baseline to week 12
Time frame: Baseline and week 12
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Change in alanine transaminase (ALT) (U/L)
Change in alanine transaminase (ALT) (U/L) from baseline to week 12
Time frame: Baseline and week 12
Change in aspartate aminotransferase (AST) (U/L)
Change in aspartate aminotransferase (AST) (U/L)
Time frame: Baseline and week 12
Change in gamma-glutamyl transferase (GGT) (U/L)
Change in gamma-glutamyl transferase (GGT) (U/L) from baseline to week 12
Time frame: Baseline and week 12
Change in urea (mmol/L)
Change in urea (mmol/L) from baseline to week 12
Time frame: Baseline and week 12
Change in estimated Glomerular Filtration Rate (eGFR) (mL/min)
Change in estimated Glomerular Filtration Rate (eGFR) (mL/min) from baseline to week 12
Time frame: Baseline and week 12
Change in creatinine (µmol/L)
Change in creatinine (µmol/L) from baseline to week 12
Time frame: Baseline and week 12
Change in Interleukin-6 (IL-6) (pg/mL)
Change in IL-6 (pg/mL) and C-reactive protein from baseline to week 12
Time frame: Baseline and week 12
Change in C-reactive protein (mg/mL)
Change in C-reactive protein (mg/mL) from baseline to week 12.
Time frame: Baseline and week 12