Overweight Adults
Conditions
Keywords
dietary fiber beverage, soya beverage, overweight, weight loss, functional drink, randomized controlled trial
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTSoya-based dietary fibre beverage
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.
Sponsors
Universiti Sains Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups: an intervention group receiving SBB supplementation or a control group
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Staff or students aged 18-50 years * Participants with BMI 23-30 kg/m2 * Participants physically inactive * Not having any allergies to any of the known food ingredients, especially milk and soy * Not on lipid-lowering and oral hypoglycemic drugs * No kidney diseases
Exclusion criteria
* Pregnant or lactating mothers * Having known chronic disease conditions * Having a known allergy history for soy and milk or any of the ingredients in the formula. * History of any type of minor or major surgical procedure in the past 6 months. * Currently on diet prescriptions or participating in regular physical activity sessions. * On weight loss drugs or consuming dietary supplements such as protein shakes, whey protein, casein, fruit juices or fiber-based supplements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in weight (kg) | Baseline, week 4, week 8 and week 12 | Changes in body weight (kg) from baseline to week 12 |
| Change in body fat percentage (%) | Baseline, week 4, week 8 and week 12 | Change in body fat percentage (%) from baseline to week 12. |
| Change in body mass index (BMI) kg/m^2 | Baseline, week 4, week 8 and week 12 | 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 |
| Change in waist circumference (cm) | Baseline, week 4, week 8 and week 12 | Change in waist circumference (cm) from baseline to week 12 |
| Change in hip circumference (cm) | Baseline, week 4, week 8 and week 12 | Changes in hip circumference (cm) from baseline to week 12 |
| Change in body fat mass (kg) | Baseline, week 4, week 8 and week 12 | Change in body fat mass (kg) from baseline to week 12. |
| Change in body fat-free mass (kg) | Baseline, week 4, week 8 and week 12 | Change in body fat-free mass (kg) from baseline to week 12. |
| Change in visceral fat rating | Baseline, week 4, week 8 and week 12 | 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. |
| Change in muscle mass (kg) | Baseline, week 4, week 8 and week 12 | Change in muscle mass (kg) from baseline to week 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in blood pressure (mmHg) | Baseline, week 4, week 8 and week 12 | Change in systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) from baseline to week 12. |
| Change in total cholesterol (mg/dL) | Baseline and week 12 | Change in total cholesterol (mg/dL) from baseline to week 12 |
| Change in low-density lipoprotein (LDL) (mg/dL) | baseline and week 12 | Change in low-density lipoprotein (LDL) (mg/dL) from baseline to week 12 |
| Change in high-density lipoprotein (HDL) (mg/dL) | Baseline and week 12 | Change in high-density lipoprotein (HDL) (mg/dL) from baseline to week 12 |
| Change in triglycerides (mg/dL) | Baseline and week 12 | Change in triglycerides (mg/dL) from baseline to week 12 |
| Change in total protein (g/L) | Baseline and week 12 | Change in total protein (g/L) from baseline to week 12 |
| Change in albumin (g/L) | Baseline and week 12 | Change in albumin (g/L) from baseline to week 12 |
| Change in bilirubin (µmol/L) | Baseline and week 12 | Change in bilirubin (µmol/L) from baseline to week 12 |
| Change in alkaline phosphatase (ALP) (U/L) | Baseline and week 12 | Change in alkaline phosphatase (ALP) (U/L) from baseline to week 12 |
| Change in alanine transaminase (ALT) (U/L) | Baseline and week 12 | Change in alanine transaminase (ALT) (U/L) from baseline to week 12 |
| Change in aspartate aminotransferase (AST) (U/L) | Baseline and week 12 | Change in aspartate aminotransferase (AST) (U/L) |
| Change in gamma-glutamyl transferase (GGT) (U/L) | Baseline and week 12 | Change in gamma-glutamyl transferase (GGT) (U/L) from baseline to week 12 |
| Change in urea (mmol/L) | Baseline and week 12 | Change in urea (mmol/L) from baseline to week 12 |
| Change in estimated Glomerular Filtration Rate (eGFR) (mL/min) | Baseline and week 12 | Change in estimated Glomerular Filtration Rate (eGFR) (mL/min) from baseline to week 12 |
| Change in creatinine (µmol/L) | Baseline and week 12 | Change in creatinine (µmol/L) from baseline to week 12 |
| Change in Interleukin-6 (IL-6) (pg/mL) | Baseline and week 12 | Change in IL-6 (pg/mL) and C-reactive protein from baseline to week 12 |
| Change in C-reactive protein (mg/mL) | Baseline and week 12 | Change in C-reactive protein (mg/mL) from baseline to week 12. |
Countries
Malaysia
Contacts
PRINCIPAL_INVESTIGATORWan Rosli Wan Ishak, PhD
School of Health Sciences, Universiti Sains Malaysia, Health Campus, 16150 Kubang Kerian, Kelantan, Malaysia
Outcome results
None listed