The Effect of a Low-calorie Diet With Balanced Nutrition on Metabolic Syndrome (NCT05703438) | Clinical Trial Compass
CompletedNot Applicable
The Effect of a Low-calorie Diet With Balanced Nutrition on Metabolic Syndrome
Indonesia50 participantsStarted 2022-08-05
Plain-language summary
The study looked at how a nutritionally balanced low-calorie diet based on traditional Indonesian foods affected obese people's metabolic biomarkers. The traditional Indonesian foods presented here are Minangkabau cuisine. Body mass index, waist circumference, systolic and diastolic blood pressure, body fat mass percentage, fasting blood sugar levels, and lipid profiles are among the metabolic biomarkers measured. The provision of a balanced nutritionally low-calorie diet based on traditional Indonesian foods, according to the researchers, will have a significant effect on the metabolic biomarkers of obese people.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Employee of RSUP dr. M. Djamil, Padang who suffers from obesity (BMI ≥ 25 kg / m2)
* Willing to follow the research by signing an informed concent
Exclusion Criteria:
* Did not come and could not be found at the time of research data collection
* Unable to follow the dietary arrangements as set
* Taking anti-diabetic or anti-lipid drugs
* Use of contraceptives or hormonal drugs
* In the treatment of radiotherapy or chemotherapyi
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline body mass index at 8 weeks.
Timeframe: up to 8 weeks
2
Change from baseline waist circumference at 8 weeks.
Timeframe: up to 8 weeks
3
Change from baseline systolic and diastolic blood pressure at 8 weeks.
Timeframe: up to 8 weeks
4
Change from baseline fat mass percentage at 8 weeks.
Timeframe: up to 8 weeks
5
Change from baseline fasting blood sugar levels at 8 weeks.
Timeframe: up to 8 weeks
6
Change from baseline lipid profile levels at 8 weeks.