Effects of a Soya-Based Fibre Beverage on Weight and Health in Overweight Adults (SBB-WEIGHTLOSS)
21 mai 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
42
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Kelantan
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Kubang Kerian, Kelantan, Malaisie, 16150
- Health Campus, Universiti Sains Malaysia
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Oui
La 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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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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Aucune intervention: Habitual diet
The control group was asked to continue their usual breakfast, lunch, and dinner meals during the study period
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in weight (kg)
Délai: 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 (%)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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)
Délai: Baseline, week 4, week 8 and week 12
|
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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in blood pressure (mmHg)
Délai: 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)
Délai: 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)
Délai: baseline and week 12
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Change in low-density lipoprotein (LDL) (mg/dL) from baseline to week 12
|
baseline and week 12
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Change in high-density lipoprotein (HDL) (mg/dL)
Délai: 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)
Délai: 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)
Délai: Baseline and week 12
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Change in total protein (g/L) from baseline to week 12
|
Baseline and week 12
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Change in albumin (g/L)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: Baseline and week 12
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Change in alanine transaminase (ALT) (U/L) from baseline to week 12
|
Baseline and week 12
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Change in aspartate aminotransferase (AST) (U/L)
Délai: Baseline and week 12
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Change in aspartate aminotransferase (AST) (U/L)
|
Baseline and week 12
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Change in gamma-glutamyl transferase (GGT) (U/L)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Physical activity level (MET-minutes/week)
Délai: 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.
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Baseline and week 12
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Change in Diet
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.
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Baseline, week 4 and week 12
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Stool amount per defecation
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Wan Rosli Wan Ishak, PhD, School of Health Sciences, Universiti Sains Malaysia, Health Campus, 16150 Kubang Kerian, Kelantan, Malaysia
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
30 juin 2025
Achèvement primaire (Réel)
1 décembre 2025
Achèvement de l'étude (Réel)
1 décembre 2025
Dates d'inscription aux études
Première soumission
15 mai 2026
Première soumission répondant aux critères de contrôle qualité
21 mai 2026
Première publication (Réel)
29 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
29 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
21 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- USM/JEPeM/KK/24111003
- R504-LR-GAL007-0000000410-M201 (Autre subvention/numéro de financement: MELILEA SDN BHD)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime 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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .