Effects of a Soya-Based Fibre Beverage on Weight and Health in Overweight Adults (SBB-WEIGHTLOSS)
2026. május 21. frissítette: Wan Rosli Wan Ishak, Universiti Sains Malaysia
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.
A tanulmány áttekintése
Állapot
Befejezve
Körülmények
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
42
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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Kelantan
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Kubang Kerian, Kelantan, Malaysia, 16150
- Health Campus, Universiti Sains Malaysia
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
Egészséges önkénteseket fogad
Igen
Leírás
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.
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Kísérleti: 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.
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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.
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Nincs beavatkozás: Habitual diet
The control group was asked to continue their usual breakfast, lunch, and dinner meals during the study period
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Change in weight (kg)
Időkeret: Baseline, week 4, week 8 and week 12
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Changes in body weight (kg) from baseline to week 12
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Baseline, week 4, week 8 and week 12
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Change in body fat percentage (%)
Időkeret: Baseline, week 4, week 8 and week 12
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Change in body fat percentage (%) from baseline to week 12.
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Baseline, week 4, week 8 and week 12
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Change in body mass index (BMI) kg/m^2
Időkeret: Baseline, week 4, week 8 and week 12
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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
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Baseline, week 4, week 8 and week 12
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Change in waist circumference (cm)
Időkeret: Baseline, week 4, week 8 and week 12
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Change in waist circumference (cm) from baseline to week 12
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Baseline, week 4, week 8 and week 12
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Change in hip circumference (cm)
Időkeret: Baseline, week 4, week 8 and week 12
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Changes in hip circumference (cm) from baseline to week 12
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Baseline, week 4, week 8 and week 12
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Change in body fat mass (kg)
Időkeret: Baseline, week 4, week 8 and week 12
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Change in body fat mass (kg) from baseline to week 12.
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Baseline, week 4, week 8 and week 12
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Change in body fat-free mass (kg)
Időkeret: Baseline, week 4, week 8 and week 12
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Change in body fat-free mass (kg) from baseline to week 12.
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Baseline, week 4, week 8 and week 12
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Change in visceral fat rating
Időkeret: Baseline, week 4, week 8 and week 12
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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.
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Baseline, week 4, week 8 and week 12
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Change in muscle mass (kg)
Időkeret: Baseline, week 4, week 8 and week 12
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Change in muscle mass (kg) from baseline to week 12.
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Baseline, week 4, week 8 and week 12
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Change in blood pressure (mmHg)
Időkeret: Baseline, week 4, week 8 and week 12
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Change in systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) from baseline to week 12.
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Baseline, week 4, week 8 and week 12
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Change in total cholesterol (mg/dL)
Időkeret: Baseline and week 12
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Change in total cholesterol (mg/dL) from baseline to week 12
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Baseline and week 12
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Change in low-density lipoprotein (LDL) (mg/dL)
Időkeret: baseline and week 12
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Change in low-density lipoprotein (LDL) (mg/dL) from baseline to week 12
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baseline and week 12
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Change in high-density lipoprotein (HDL) (mg/dL)
Időkeret: Baseline and week 12
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Change in high-density lipoprotein (HDL) (mg/dL) from baseline to week 12
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Baseline and week 12
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Change in triglycerides (mg/dL)
Időkeret: Baseline and week 12
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Change in triglycerides (mg/dL) from baseline to week 12
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Baseline and week 12
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Change in total protein (g/L)
Időkeret: Baseline and week 12
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Change in total protein (g/L) from baseline to week 12
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Baseline and week 12
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Change in albumin (g/L)
Időkeret: Baseline and week 12
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Change in albumin (g/L) from baseline to week 12
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Baseline and week 12
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Change in bilirubin (µmol/L)
Időkeret: Baseline and week 12
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Change in bilirubin (µmol/L) from baseline to week 12
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Baseline and week 12
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Change in alkaline phosphatase (ALP) (U/L)
Időkeret: Baseline and week 12
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Change in alkaline phosphatase (ALP) (U/L) from baseline to week 12
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Baseline and week 12
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Change in alanine transaminase (ALT) (U/L)
Időkeret: Baseline and week 12
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Change in alanine transaminase (ALT) (U/L) from baseline to week 12
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Baseline and week 12
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Change in aspartate aminotransferase (AST) (U/L)
Időkeret: Baseline and week 12
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Change in aspartate aminotransferase (AST) (U/L)
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Baseline and week 12
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Change in gamma-glutamyl transferase (GGT) (U/L)
Időkeret: Baseline and week 12
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Change in gamma-glutamyl transferase (GGT) (U/L) from baseline to week 12
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Baseline and week 12
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Change in urea (mmol/L)
Időkeret: Baseline and week 12
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Change in urea (mmol/L) from baseline to week 12
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Baseline and week 12
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Change in estimated Glomerular Filtration Rate (eGFR) (mL/min)
Időkeret: Baseline and week 12
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Change in estimated Glomerular Filtration Rate (eGFR) (mL/min) from baseline to week 12
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Baseline and week 12
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Change in creatinine (µmol/L)
Időkeret: Baseline and week 12
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Change in creatinine (µmol/L) from baseline to week 12
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Baseline and week 12
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Change in Interleukin-6 (IL-6) (pg/mL)
Időkeret: Baseline and week 12
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Change in IL-6 (pg/mL) and C-reactive protein from baseline to week 12
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Baseline and week 12
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Change in C-reactive protein (mg/mL)
Időkeret: Baseline and week 12
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Change in C-reactive protein (mg/mL) from baseline to week 12.
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Baseline and week 12
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Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Physical activity level (MET-minutes/week)
Időkeret: Baseline and week 12
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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.
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Baseline and week 12
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Change in Diet
Időkeret: Baseline, week 4 and week 12
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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.
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Baseline, week 4 and week 12
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Change in appetite
Időkeret: Baseline, week 4 and week 12
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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.
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Baseline, week 4 and week 12
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Frequency of defecation
Időkeret: Baseline, week 4 and week 12
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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.
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Baseline, week 4 and week 12
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Time of defecation
Időkeret: Baseline, week 4 and week 12
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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.
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Baseline, week 4 and week 12
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Stool consistency
Időkeret: Baseline, week 4 and week 12
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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.
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Baseline, week 4 and week 12
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Stool color
Időkeret: Baseline, week 4 and week 12
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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.
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Baseline, week 4 and week 12
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Stool amount per defecation
Időkeret: Baseline, week 4 and week 12
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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.
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Baseline, week 4 and week 12
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Feces odor
Időkeret: Baseline, week 4 and week 12
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Feces odor will be assessed using the Questionnaire of Regularity of Defecation Behavior and categorized as regular or irregular.
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Baseline, week 4 and week 12
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Ease of defecation
Időkeret: Baseline, week 4 and week 12
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Ease of defecation will be assessed using the Questionnaire of Regularity of Defecation Behavior and categorized as easy or hard defecation.
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Baseline, week 4 and week 12
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Effect on quality of life
Időkeret: Baseline and week 12
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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).
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Baseline and week 12
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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Nyomozók
- Kutatásvezető: Wan Rosli Wan Ishak, PhD, School of Health Sciences, Universiti Sains Malaysia, Health Campus, 16150 Kubang Kerian, Kelantan, Malaysia
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
2025. június 30.
Elsődleges befejezés (Tényleges)
2025. december 1.
A tanulmány befejezése (Tényleges)
2025. december 1.
Tanulmányi regisztráció dátumai
Először benyújtva
2026. május 15.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2026. május 21.
Első közzététel (Tényleges)
2026. május 29.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2026. május 29.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2026. május 21.
Utolsó ellenőrzés
2026. május 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- USM/JEPeM/KK/24111003
- R504-LR-GAL007-0000000410-M201 (Egyéb támogatási/finanszírozási szám: MELILEA SDN BHD)
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
NEM
IPD terv leírása
Individual participant data will not be made publicly available to protect participant confidentiality and comply with institutional and ethical regulations governing clinical research data.
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