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Overweight AdultsSBB-WEIGHTLOSSNCT07614178

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

A study testing Soya-based dietary fibre beverage in people with Overweight Adults, run by Universiti Sains Malaysia at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Overweight Adults
What is being tested?
Soya-based dietary fibre beverage
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteMalaysia
Study dates
30 Jun 2025to 1 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

  • Health Campus, Universiti Sains Malaysia

    Kubang Kerian, Kelantan, 16150

Other trials in Malaysia

About this study

Official 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

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.

Read the detailed description

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.

Being tested
Soya-based dietary fibre beverage
Keywords
dietary fiber beverage, soya beverage, overweight, weight loss, functional drink, randomized controlled trial
Medical subject headings
Overweight, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Soya-based dietary fibre beverageDietary 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.

Study groups in NCT07614178
Study groupRoleWhat they receive
Soya-based dietary fibre beverageExperimentalThe 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.
Receives: Dietary Supplement: Soya-based dietary fibre beverage
Habitual dietNo interventionThe control group was asked to continue their usual breakfast, lunch, and dinner meals during the study period

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in weight (kg)

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

    Measured: Baseline, week 4, week 8 and week 12

  2. Change in body fat percentage (%)

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

    Measured: Baseline, week 4, week 8 and week 12

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

    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

    Measured: Baseline, week 4, week 8 and week 12

  4. Change in waist circumference (cm)

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

    Measured: Baseline, week 4, week 8 and week 12

  5. Change in hip circumference (cm)

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

    Measured: Baseline, week 4, week 8 and week 12

  6. Change in body fat mass (kg)

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

    Measured: Baseline, week 4, week 8 and week 12

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

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

    Measured: Baseline, week 4, week 8 and week 12

  8. Change in visceral fat rating

    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.

    Measured: Baseline, week 4, week 8 and week 12

  9. Change in muscle mass (kg)

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

    Measured: Baseline, week 4, week 8 and week 12

Secondary outcomes (17)

  1. Change in blood pressure (mmHg)

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

    Measured: Baseline, week 4, week 8 and week 12

  2. Change in total cholesterol (mg/dL)

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

    Measured: Baseline and week 12

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

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

    Measured: baseline and week 12

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

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

    Measured: Baseline and week 12

  5. Change in triglycerides (mg/dL)

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

    Measured: Baseline and week 12

  6. Change in total protein (g/L)

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

    Measured: Baseline and week 12

  7. Change in albumin (g/L)

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

    Measured: Baseline and week 12

  8. Change in bilirubin (µmol/L)

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

    Measured: Baseline and week 12

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

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

    Measured: Baseline and week 12

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

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

    Measured: Baseline and week 12

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

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

    Measured: Baseline and week 12

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

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

    Measured: Baseline and week 12

  13. Change in urea (mmol/L)

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

    Measured: Baseline and week 12

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

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

    Measured: Baseline and week 12

  15. Change in creatinine (µmol/L)

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

    Measured: Baseline and week 12

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

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

    Measured: Baseline and week 12

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

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

    Measured: Baseline and week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2026
  2. Study start30 Jun 2025
  3. Primary completion1 Dec 2025
  4. Study completion1 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups: an intervention group receiving SBB supplementation or a control group
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07614178
Sponsor's protocol ID
USM/JEPeM/KK/24111003
Other IDs
R504-LR-GAL007-0000000410-M201
Acronym
SBB-WEIGHTLOSS
Status last verified
May 2026
First submitted
15 May 2026
Last updated
29 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be made publicly available to protect participant confidentiality and comply with institutional and ethical regulations governing clinical research data.

Questions about this trial

What is this clinical trial studying?

A study testing Soya-based dietary fibre beverage in people with Overweight Adults, run by Universiti Sains Malaysia at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in weight (kg) (time frame: Baseline, week 4, week 8 and week 12). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07614178.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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