- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07371949
CHRONO-NUTRITION APPLICATION: THE EFFECT OF FIBER JELLY ON POST PRANDIAL BLOOD GLUCOSE, SATIETY AND WEIGHT LOSS AMONG OVERWEIGHT WOMEN
APLIKASI CHRONO- NUTRITION : PENGARUH FIBER JELLY TERHADAP RESPON GLUKOSA DARAH, KEKENYANGAN POST PRANDIAL, DAN WEIGH LOSS PADA WANITA OVERWEIGHT"
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?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Indonesia
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Surabaya, Indonesia, Indonesia, 60213
- Faculty of Sports and Health Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Intervention
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).
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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).
Other Names:
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Placebo Comparator: Placebo
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 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).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Blood Glucose level
Time Frame: 0, 30, 45, 60, 90, 120 minute
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Post prandial blood glucose level
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0, 30, 45, 60, 90, 120 minute
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Appetite level
Time Frame: 0 minute, 30 minute, 45 minute, 60 minute, 90 minute, 120 minute, 180 minute, 240 minute
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Visual analog scale of hunger, fullness, appetite, prospective food, and satisfaction
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0 minute, 30 minute, 45 minute, 60 minute, 90 minute, 120 minute, 180 minute, 240 minute
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- No.004/UN38.10/EC.KEPK/HK.01.0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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