NCT07371949

Brief Summary

The goal of this observational study is to learn about the effects of pre meal fiber jelly in overweight women over the age of 20-60 who take intervention pre meal fiber jelly on their postprandial blood glucose level and appetite level. The main question it aims to answer is: Does pre meal fiber jelly in overweight women effect on their postprandial blood glucose level and appetite level?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2025

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 2, 2026

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 28, 2026

Completed
Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

January 2, 2026

Last Update Submit

January 21, 2026

Conditions

Keywords

overweight

Outcome Measures

Primary Outcomes (2)

  • Blood Glucose level

    Post prandial blood glucose level

    0, 30, 45, 60, 90, 120 minute

  • Appetite level

    Visual analog scale of hunger, fullness, appetite, prospective food, and satisfaction

    0 minute, 30 minute, 45 minute, 60 minute, 90 minute, 120 minute, 180 minute, 240 minute

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Fibre jelly was formulated using basil seeds, psyllium husk, rosella water extract, and carrageenan. Fibre jelly contained approximately 7.89 g of fibre in each pouch (\~100 g).

Combination Product: Fiber jelly

Placebo

PLACEBO COMPARATOR

the control jelly was formulated using water and carrageenan as a gelling agent. Both types of jelly contained the same amount of stevia and fructose as sweeteners.

Combination Product: Fiber jelly

Interventions

Fiber jellyCOMBINATION_PRODUCT

Fibre jelly was formulated using basil seeds, psyllium husk, rosella water extract, and carrageenan, while the control jelly was formulated using water and carrageenan as a gelling agent. Both types of jelly contained the same amount of stevia and fructose as sweeteners. Fibre jelly contained approximately 7.89 g of fibre in each pouch (\~100 g).

Also known as: Intervention
InterventionPlacebo

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsthe study enrolls only biological females
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • (1) female adults aged between 20-60 years; (2) having fasting blood glucose level \<125 mg/dL; (3) having body mass index (BMI) more than or equal to 23; (4) not undergoing loss weight program during the recruitment process; (5) not allergic to rosella and basil seed

You may not qualify if:

  • Candidates were excluded if they were pregnant or lactating, had any medical conditions, including gastrointestinal disorders, cardiovascular disease, or other chronic diseases, smoking, or consuming alcohol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Sports and Health Sciences

Surabaya, Indonesia, 60213, Indonesia

Location

MeSH Terms

Conditions

Overweight

Interventions

Methods

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 2, 2026

First Posted

January 28, 2026

Study Start

June 30, 2025

Primary Completion

December 14, 2025

Study Completion

December 14, 2025

Last Updated

January 28, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

The data will not shared to protect respondent privacy

Locations