Effects of a Soya-Based Fibre Beverage on Weight and Health in Overweight Adults (SBB-WEIGHTLOSS)

Research on the Effect of Soya-Based Dietary Fibre Beverages (SBB) in Improving Anthropometric Parameters and Biomarker Profiles Among Overweight Students and Staff in Health Campus, Universiti Sains Malaysia, Kelantan

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.

Study Overview

• Status: Completed
• Conditions: Overweight Adults
• Intervention / Treatment: Dietary supplement: Soya-based dietary fibre beverage

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Kelantan
    • Kubang Kerian, Kelantan, Malaysia, 16150
      • Health Campus, Universiti Sains Malaysia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Soya-based dietary fibre beverage; The SBB beverage was in powdered form (1 sachet contain 53g of powder), and participants were instructed to prepare the liquid shake by mixing the 1 sachet of the powder with 250 mL of cold water in a shaker that had been provided. They were asked to consume two servings of the beverage at least 30 min before each breakfast and teatime every day for 12 weeks. The intervention group was given a sufficiently SBB sachet with a label indicating the ingredients and the preparation method. The breakfast, lunch, and dinner meals were recommended as normal meals (the meals that they habitually eat). The intervention involved the consumption of the SBB beverage powder while allowing participants to maintain their usual meal portions. 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.	Dietary supplement: Soya-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.
No Intervention: Habitual diet; The control group was asked to continue their usual breakfast, lunch, and dinner meals during the study period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in weight (kg)	Changes in body weight (kg) from baseline to week 12	Baseline, week 4, week 8 and week 12
Change in body fat percentage (%)	Change in body fat percentage (%) from baseline to week 12.	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	Baseline, week 4, week 8 and week 12
Change in waist circumference (cm)	Change in waist circumference (cm) from baseline to week 12	Baseline, week 4, week 8 and week 12
Change in hip circumference (cm)	Changes in hip circumference (cm) from baseline to week 12	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.	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.	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.	Baseline, week 4, week 8 and week 12
Change in muscle mass (kg)	Change in muscle mass (kg) from baseline to week 12.	Baseline, week 4, week 8 and week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood pressure (mmHg)	Change in systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) from baseline to week 12.	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	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	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	Baseline and week 12
Change in triglycerides (mg/dL)	Change in triglycerides (mg/dL) from baseline to week 12	Baseline and week 12
Change in total protein (g/L)	Change in total protein (g/L) from baseline to week 12	Baseline and week 12
Change in albumin (g/L)	Change in albumin (g/L) from baseline to week 12	Baseline and week 12
Change in bilirubin (µmol/L)	Change in bilirubin (µmol/L) from baseline to week 12	Baseline and week 12
Change in alkaline phosphatase (ALP) (U/L)	Change in alkaline phosphatase (ALP) (U/L) from baseline to week 12	Baseline and week 12
Change in alanine transaminase (ALT) (U/L)	Change in alanine transaminase (ALT) (U/L) from baseline to week 12	Baseline and week 12
Change in aspartate aminotransferase (AST) (U/L)	Change in aspartate aminotransferase (AST) (U/L)	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	Baseline and week 12
Change in urea (mmol/L)	Change in urea (mmol/L) from baseline to week 12	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	Baseline and week 12
Change in creatinine (µmol/L)	Change in creatinine (µmol/L) from baseline to week 12	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	Baseline and week 12
Change in C-reactive protein (mg/mL)	Change in C-reactive protein (mg/mL) from baseline to week 12.	Baseline and week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity level (MET-minutes/week)	Physical activity was assessed using the Malay version of the International Physical Activity Questionnaire (IPAQ). The data was processed according to the official IPAQ scoring protocol. The results are reported as continuous scores expressed in Metabolic Equivalent of Task (MET)-minutes per week. Higher scores indicate a greater volume of physical activity expenditure.	Baseline and week 12
Change in Diet	Change in average daily diet intake, assessed using 24-hour recalls and 3-day food records. Dietary data were entered into Nutritionist Pro™ software (Axxya Systems, USA) to estimate mean daily energy and nutrient intake, including macronutrients and dietary fibre. For food items that are not available in the Malaysian Nutrient Composition of Foods, the USDA nutrient database was referred. For mixed dishes that were not available in the database, local recipes were entered into the software.	Baseline, week 4 and week 12
Change in appetite	Subjective appetite sensations were assessed using an eleven-point numerical rating scale (NRS), with anchors at 0 ("not at all") and 10 ("very much"), to evaluate hunger, fullness, desire to eat, thirst, and prospective food consumption. Participants completed the questionnaire before and after breakfast, lunch, and dinner at each study time point (pre, week 4, and post). For analysis and comparability with conventional visual analogue scale (VAS) methods, NRS scores were linearly transformed to a 0-100 scale by multiplying each value by 10.	Baseline, week 4 and week 12
Frequency of defecation	Frequency of defecation will be assessed using the Questionnaire of Regularity of Defecation Behavior. Participants will report the frequency of bowel movements categorized as 1 time/day, more than 1 time/day, 2-3 times/week, or 4-5 times/week.	Baseline, week 4 and week 12
Time of defecation	Time of defecation will be assessed using the Questionnaire of Regularity of Defecation Behavior. Participants will report the usual timing of bowel movements within specified time intervals over a 24-hour period.	Baseline, week 4 and week 12
Stool consistency	Stool consistency will be assessed using the Bristol Stool Form Scale, a 7-point scale ranging from Type 1 (hard lumps indicating constipation) to Type 7 (watery stool indicating diarrhea). Types 3 and 4 indicate normal stool consistency.	Baseline, week 4 and week 12
Stool color	Stool color will be assessed using the Questionnaire of Regularity of Defecation Behavior. Participants will report stool color categorized as brown, yellow, black, red, green, or blue.	Baseline, week 4 and week 12
Stool amount per defecation	Amount of stool per defecation will be assessed using the Questionnaire of Regularity of Defecation Behavior and categorized as 1-2 stools, 3-4 stools, or more than 5 stools.	Baseline, week 4 and week 12
Feces odor	Feces odor will be assessed using the Questionnaire of Regularity of Defecation Behavior and categorized as regular or irregular.	Baseline, week 4 and week 12
Ease of defecation	Ease of defecation will be assessed using the Questionnaire of Regularity of Defecation Behavior and categorized as easy or hard defecation.	Baseline, week 4 and week 12
Effect on quality of life	The quality of life outcome will be assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire, a 26-item instrument evaluating four domains: physical health, psychological health, social relationships, and environment. Each domain score ranges from 0 to 100, with higher scores indicating better quality of life. Assessments will be conducted at baseline (pre-intervention) and after completion of the intervention (post-intervention).	Baseline and week 12

Collaborators and Investigators

• Sponsor: Universiti Sains Malaysia
• Investigators: Principal Investigator: Wan Rosli Wan Ishak, PhD, School of Health Sciences, Universiti Sains Malaysia, Health Campus, 16150 Kubang Kerian, Kelantan, Malaysia

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2025
• Primary Completion (Actual): December 1, 2025
• Study Completion (Actual): December 1, 2025

Study Registration Dates

• First Submitted: May 15, 2026
• First Submitted That Met QC Criteria: May 21, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: randomized controlled trial; overweight; weight loss; dietary fiber beverage; soya beverage; functional drink
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Body Weight Changes; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Weight Loss
• Other Study ID Numbers: USM/JEPeM/KK/24111003; R504-LR-GAL007-0000000410-M201 (Other Grant/Funding Number: MELILEA SDN BHD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be made publicly available to protect participant confidentiality and comply with institutional and ethical regulations governing clinical research data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No