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

NCT07614178 | Completed DMC

• 2 other identifiers: USM/JEPeM/KK/24111003R504-LR-GAL007-0000000410-M201
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight Adults

Keywords

dietary fiber beverage; soya beverage; overweight; weight loss; functional drink; randomized controlled trial

Outcome Measures

Primary Outcomes (9)

• Change in weight (kg)

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

  Baseline, week 4, week 8 and week 12

• Change in body fat percentage (%)

  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

  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)

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

  Baseline, week 4, week 8 and week 12

• Change in hip circumference (cm)

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

  Baseline, week 4, week 8 and week 12

• Change in body fat mass (kg)

  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)

  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

  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)

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

  Baseline, week 4, week 8 and week 12

Secondary Outcomes (17)

• Change in blood pressure (mmHg)

  Baseline, week 4, week 8 and week 12

• Change in total cholesterol (mg/dL)

  Baseline and week 12

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

  baseline and week 12

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

  Baseline and week 12

• Change in triglycerides (mg/dL)

  Baseline and week 12

Other Outcomes (11)

• Physical activity level (MET-minutes/week)

  Baseline and week 12

• Change in Diet

  Baseline, week 4 and week 12

• Change in appetite

  Baseline, week 4 and week 12

Study Arms (2)

Soya-based dietary fibre beverage

EXPERIMENTAL

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.

Dietary Supplement: Soya-based dietary fibre beverage

Habitual diet

NO INTERVENTION

The control group was asked to continue their usual breakfast, lunch, and dinner meals during the study period

Interventions

Soya-based dietary fibre beverage DIETARY_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.

Soya-based dietary fibre beverage

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Health Campus, Universiti Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

Location

MeSH Terms

Conditions

Overweight; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Wan Rosli Wan Ishak, PhD

  School of Health Sciences, Universiti Sains Malaysia, Health Campus, 16150 Kubang Kerian, Kelantan, Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of School of Health Sciences, USM Health Campus

Model Details: 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

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 29, 2026
• Study Start: June 30, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)