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CHRONO-NUTRITION APPLICATION: THE EFFECT OF FIBER JELLY ON POST PRANDIAL BLOOD GLUCOSE, SATIETY AND WEIGHT LOSS AMONG OVERWEIGHT WOMEN

S

Surabaya State University

Status

Completed

Conditions

Overweight and Obese Adults

Treatments

Combination Product: Fiber jelly

Study type

Interventional

Funder types

Other

Identifiers

NCT07371949
No.004/UN38.10/EC.KEPK/HK.01.0

Details and patient eligibility

About

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?

Full description

Prior to the test days, participants were asked to fast overnight following the standard procedure for fasting blood glucose measurement. Additionally, participants were asked to refrain from vigorous physical activity prior to the test days. On the test days, fasting blood glucose was taken prior to the breakfast test meal at 0 minute. Then, participants were asked to consume fibre jelly for those in the intervention group and carrageenan-based jelly for those in the control group. After consuming jelly, participants from both groups were asked to consume bread, which was equal to 50 grams of starch and 250 ml of water in 10 minutes. To measure their postprandial blood glucose levels, participants were required to fast for the next 2 hours. After blood samples were collected, participants were provided with a complete meal and unlimited water. Participants were allowed to eat and drink as much as they desire following their satiety and hunger cues (ad-libitum). The remaining foods were weighed to calculate the total calories consumed by participants.

Enrollment

28 patients

Sex

Female

Ages

20 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

(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

Exclusion criteria

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

28 participants in 2 patient groups, including a placebo group

Intervention
Active Comparator group
Description:
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).
Treatment:
Combination Product: Fiber jelly
Placebo
Placebo Comparator group
Description:
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.
Treatment:
Combination Product: Fiber jelly

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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