Effects of a Soya-Based Fibre Beverage on Weight and Health in Overweight Adults (SBB-WEIGHTLOSS)
21. května 2026 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
42
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Kelantan
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Kubang Kerian, Kelantan, Malajsie, 16150
- Health Campus, Universiti Sains Malaysia
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Ano
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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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Žádný zásah: Habitual diet
The control group was asked to continue their usual breakfast, lunch, and dinner meals during the study period
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in weight (kg)
Časové okno: 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 (%)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in blood pressure (mmHg)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Physical activity level (MET-minutes/week)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Wan Rosli Wan Ishak, PhD, School of Health Sciences, Universiti Sains Malaysia, Health Campus, 16150 Kubang Kerian, Kelantan, Malaysia
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
30. června 2025
Primární dokončení (Aktuální)
1. prosince 2025
Dokončení studie (Aktuální)
1. prosince 2025
Termíny zápisu do studia
První předloženo
15. května 2026
První předloženo, které splnilo kritéria kontroly kvality
21. května 2026
První zveřejněno (Aktuální)
29. května 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
29. května 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
21. května 2026
Naposledy ověřeno
1. května 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- USM/JEPeM/KK/24111003
- R504-LR-GAL007-0000000410-M201 (Jiné číslo grantu/financování: MELILEA SDN BHD)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Popis plánu IPD
Individual participant data will not be made publicly available to protect participant confidentiality and comply with institutional and ethical regulations governing clinical research data.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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