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Completed

NCT Number: NCT07614178

Effects of a Soya-Based Fibre Beverage on Weight and Health in Overweight Adults

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Campus, Universiti Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Soya-based dietary fibre beverage

Dietary Supplement

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.

Primary outcomes

  1. Change in weight (kg)

    Time frame: Baseline, week 4, week 8 and week 12

    Changes in body weight (kg) from baseline to week 12

  2. Change in body fat percentage (%)

    Time frame: Baseline, week 4, week 8 and week 12

    Change in body fat percentage (%) from baseline to week 12.

  3. Change in body mass index (BMI) kg/m^2

    Time frame: 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

  4. Change in waist circumference (cm)

    Time frame: Baseline, week 4, week 8 and week 12

    Change in waist circumference (cm) from baseline to week 12

  5. Change in hip circumference (cm)

    Time frame: Baseline, week 4, week 8 and week 12

    Changes in hip circumference (cm) from baseline to week 12

  6. Change in body fat mass (kg)

    Time frame: Baseline, week 4, week 8 and week 12

    Change in body fat mass (kg) from baseline to week 12.

  7. Change in body fat-free mass (kg)

    Time frame: Baseline, week 4, week 8 and week 12

    Change in body fat-free mass (kg) from baseline to week 12.

  8. Change in visceral fat rating

    Time frame: 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.

  9. Change in muscle mass (kg)

    Time frame: Baseline, week 4, week 8 and week 12

    Change in muscle mass (kg) from baseline to week 12.

Secondary outcomes

  1. Change in blood pressure (mmHg)

    Time frame: Baseline, week 4, week 8 and week 12

    Change in systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) from baseline to week 12.

  2. Change in total cholesterol (mg/dL)

    Time frame: Baseline and week 12

    Change in total cholesterol (mg/dL) from baseline to week 12

  3. Change in low-density lipoprotein (LDL) (mg/dL)

    Time frame: baseline and week 12

    Change in low-density lipoprotein (LDL) (mg/dL) from baseline to week 12

  4. Change in high-density lipoprotein (HDL) (mg/dL)

    Time frame: Baseline and week 12

    Change in high-density lipoprotein (HDL) (mg/dL) from baseline to week 12

  5. Change in triglycerides (mg/dL)

    Time frame: Baseline and week 12

    Change in triglycerides (mg/dL) from baseline to week 12

  6. Change in total protein (g/L)

    Time frame: Baseline and week 12

    Change in total protein (g/L) from baseline to week 12

  7. Change in albumin (g/L)

    Time frame: Baseline and week 12

    Change in albumin (g/L) from baseline to week 12

  8. Change in bilirubin (µmol/L)

    Time frame: Baseline and week 12

    Change in bilirubin (µmol/L) from baseline to week 12

  9. Change in alkaline phosphatase (ALP) (U/L)

    Time frame: Baseline and week 12

    Change in alkaline phosphatase (ALP) (U/L) from baseline to week 12

  10. Change in alanine transaminase (ALT) (U/L)

    Time frame: Baseline and week 12

    Change in alanine transaminase (ALT) (U/L) from baseline to week 12

  11. Change in aspartate aminotransferase (AST) (U/L)

    Time frame: Baseline and week 12

    Change in aspartate aminotransferase (AST) (U/L)

  12. Change in gamma-glutamyl transferase (GGT) (U/L)

    Time frame: Baseline and week 12

    Change in gamma-glutamyl transferase (GGT) (U/L) from baseline to week 12

  13. Change in urea (mmol/L)

    Time frame: Baseline and week 12

    Change in urea (mmol/L) from baseline to week 12

  14. Change in estimated Glomerular Filtration Rate (eGFR) (mL/min)

    Time frame: Baseline and week 12

    Change in estimated Glomerular Filtration Rate (eGFR) (mL/min) from baseline to week 12

  15. Change in creatinine (µmol/L)

    Time frame: Baseline and week 12

    Change in creatinine (µmol/L) from baseline to week 12

  16. Change in Interleukin-6 (IL-6) (pg/mL)

    Time frame: Baseline and week 12

    Change in IL-6 (pg/mL) and C-reactive protein from baseline to week 12

  17. Change in C-reactive protein (mg/mL)

    Time frame: Baseline and week 12

    Change in C-reactive protein (mg/mL) from baseline to week 12.

Other outcomes

  1. Physical activity level (MET-minutes/week)

    Time frame: Baseline and week 12

    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.

  2. Change in Diet

    Time frame: Baseline, week 4 and week 12

    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.

  3. Change in appetite

    Time frame: Baseline, week 4 and week 12

    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.

  4. Frequency of defecation

    Time frame: Baseline, week 4 and week 12

    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.

  5. Time of defecation

    Time frame: Baseline, week 4 and week 12

    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.

  6. Stool consistency

    Time frame: Baseline, week 4 and week 12

    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.

  7. Stool color

    Time frame: Baseline, week 4 and week 12

    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.

  8. Stool amount per defecation

    Time frame: Baseline, week 4 and week 12

    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.

  9. Feces odor

    Time frame: Baseline, week 4 and week 12

    Feces odor will be assessed using the Questionnaire of Regularity of Defecation Behavior and categorized as regular or irregular.

  10. Ease of defecation

    Time frame: Baseline, week 4 and week 12

    Ease of defecation will be assessed using the Questionnaire of Regularity of Defecation Behavior and categorized as easy or hard defecation.

  11. Effect on quality of life

    Time frame: Baseline and week 12

    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).

Sponsors and collaborators

Lead sponsor

Universiti Sains Malaysia

Other

Registry information

Official study title

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

Acronym: SBB-WEIGHTLOSS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 29, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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