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Clinical Trials/NCT07614178
NCT07614178CompletedNot Applicable

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

Universiti Sains Malaysia1 site in 1 country42 target enrollmentStarted: June 30, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
42
Locations
1

Study Overview

Brief 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 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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Wan Rosli Wan Ishak

Dean of School of Health Sciences, USM Health Campus

Universiti Sains Malaysia

Study Sites (1)

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