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

21. maj 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

42

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Kosttilskud: 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.
Ingen indgriben: Habitual diet
The control group was asked to continue their usual breakfast, lunch, and dinner meals during the study period

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in weight (kg)
Tidsramme: Baseline, week 4, week 8 and week 12
Changes in body weight (kg) from baseline to week 12
Baseline, week 4, week 8 and week 12
Change in body fat percentage (%)
Tidsramme: Baseline, week 4, week 8 and week 12
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
Tidsramme: 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
Baseline, week 4, week 8 and week 12
Change in waist circumference (cm)
Tidsramme: Baseline, week 4, week 8 and week 12
Change in waist circumference (cm) from baseline to week 12
Baseline, week 4, week 8 and week 12
Change in hip circumference (cm)
Tidsramme: Baseline, week 4, week 8 and week 12
Changes in hip circumference (cm) from baseline to week 12
Baseline, week 4, week 8 and week 12
Change in body fat mass (kg)
Tidsramme: Baseline, week 4, week 8 and week 12
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)
Tidsramme: Baseline, week 4, week 8 and week 12
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
Tidsramme: 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.
Baseline, week 4, week 8 and week 12
Change in muscle mass (kg)
Tidsramme: Baseline, week 4, week 8 and week 12
Change in muscle mass (kg) from baseline to week 12.
Baseline, week 4, week 8 and week 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in blood pressure (mmHg)
Tidsramme: Baseline, week 4, week 8 and week 12
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)
Tidsramme: Baseline and week 12
Change in total cholesterol (mg/dL) from baseline to week 12
Baseline and week 12
Change in low-density lipoprotein (LDL) (mg/dL)
Tidsramme: baseline and week 12
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)
Tidsramme: Baseline and week 12
Change in high-density lipoprotein (HDL) (mg/dL) from baseline to week 12
Baseline and week 12
Change in triglycerides (mg/dL)
Tidsramme: Baseline and week 12
Change in triglycerides (mg/dL) from baseline to week 12
Baseline and week 12
Change in total protein (g/L)
Tidsramme: Baseline and week 12
Change in total protein (g/L) from baseline to week 12
Baseline and week 12
Change in albumin (g/L)
Tidsramme: Baseline and week 12
Change in albumin (g/L) from baseline to week 12
Baseline and week 12
Change in bilirubin (µmol/L)
Tidsramme: Baseline and week 12
Change in bilirubin (µmol/L) from baseline to week 12
Baseline and week 12
Change in alkaline phosphatase (ALP) (U/L)
Tidsramme: Baseline and week 12
Change in alkaline phosphatase (ALP) (U/L) from baseline to week 12
Baseline and week 12
Change in alanine transaminase (ALT) (U/L)
Tidsramme: Baseline and week 12
Change in alanine transaminase (ALT) (U/L) from baseline to week 12
Baseline and week 12
Change in aspartate aminotransferase (AST) (U/L)
Tidsramme: Baseline and week 12
Change in aspartate aminotransferase (AST) (U/L)
Baseline and week 12
Change in gamma-glutamyl transferase (GGT) (U/L)
Tidsramme: Baseline and week 12
Change in gamma-glutamyl transferase (GGT) (U/L) from baseline to week 12
Baseline and week 12
Change in urea (mmol/L)
Tidsramme: Baseline and week 12
Change in urea (mmol/L) from baseline to week 12
Baseline and week 12
Change in estimated Glomerular Filtration Rate (eGFR) (mL/min)
Tidsramme: Baseline and week 12
Change in estimated Glomerular Filtration Rate (eGFR) (mL/min) from baseline to week 12
Baseline and week 12
Change in creatinine (µmol/L)
Tidsramme: Baseline and week 12
Change in creatinine (µmol/L) from baseline to week 12
Baseline and week 12
Change in Interleukin-6 (IL-6) (pg/mL)
Tidsramme: Baseline and week 12
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)
Tidsramme: Baseline and week 12
Change in C-reactive protein (mg/mL) from baseline to week 12.
Baseline and week 12

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Physical activity level (MET-minutes/week)
Tidsramme: 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.
Baseline and week 12
Change in Diet
Tidsramme: 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.
Baseline, week 4 and week 12
Change in appetite
Tidsramme: 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.
Baseline, week 4 and week 12
Frequency of defecation
Tidsramme: 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.
Baseline, week 4 and week 12
Time of defecation
Tidsramme: 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.
Baseline, week 4 and week 12
Stool consistency
Tidsramme: 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.
Baseline, week 4 and week 12
Stool color
Tidsramme: 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.
Baseline, week 4 and week 12
Stool amount per defecation
Tidsramme: 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.
Baseline, week 4 and week 12
Feces odor
Tidsramme: 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.
Baseline, week 4 and week 12
Ease of defecation
Tidsramme: 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.
Baseline, week 4 and week 12
Effect on quality of life
Tidsramme: 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).
Baseline and week 12

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Universiti Sains Malaysia

Efterforskere

  • Ledende efterforsker: Wan Rosli Wan Ishak, PhD, School of Health Sciences, Universiti Sains Malaysia, Health Campus, 16150 Kubang Kerian, Kelantan, Malaysia

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. juni 2025

Primær færdiggørelse (Faktiske)

1. december 2025

Studieafslutning (Faktiske)

1. december 2025

Datoer for studieregistrering

Først indsendt

15. maj 2026

Først indsendt, der opfyldte QC-kriterier

21. maj 2026

Først opslået (Faktiske)

29. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • USM/JEPeM/KK/24111003
  • R504-LR-GAL007-0000000410-M201 (Andet bevillings-/finansieringsnummer: MELILEA SDN BHD)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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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