Metabolic Syndrome, Protection AgainstNCT05703438
The Effect of a Low-calorie Diet With Balanced Nutrition on Metabolic Syndrome
A study testing Nutritionally balanced low-calorie diet in people with Metabolic Syndrome, Protection Against, run by Andalas University at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Protection Against
- What is being tested?
- Nutritionally balanced low-calorie diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndonesia
- Study dates
- 5 Aug 2022to 4 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Nutritionally Balanced Low Calorie Diet Based on Traditional Indonesian Foods on Obese People's Metabolic Biomarkers
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.
Read the detailed description
The research was carried out at RSUP dr. M. Djamil Padang. The research ethics commission of Andalas University's Faculty of Medicine granted the study an ethical permit. Health workers with a BMI of more than 25 kg/m2 became the study population, and officers who agreed to participate in the study after filling out the informed consent form were included in the study. There were 91 people in the study. The study lasted eight weeks (56 days). A week before the study, participants were interviewed about their daily intake using 24-hour food recall, and anthropometric measurements were taken using calibrated tools and performed by trained officers.
Subjects underwent a one-week pre-treatment period (baseline period, beginning on D-day 6 and ending on D-day 0), during which they were asked not to take any supplements. All participants had their anthropometric measurement, blood pressure, body fat percentage, fasting blood sugar levels, and lipid profile checked on day 0 and day 57.
The Nutrisurvey 2005 application was used to process the daily intake of participants obtained from a 24-hour food recall interview. Dietary interventions were given with a calorie deficit of 500-600 kcal from the participants' usual daily intake. A Minangkabau food menu is provided as part of the diet. Participants are given a list of daily menus, which include breakfast, lunch, and dinner. Researchers provided lunch for study participants, while breakfast and dinner were prepared independently by participants using the dietary guidelines and menus provided. Participants kept a food diary, which was collected and evaluated twice a week. The research team also controls and motivates all participants via Whatsapp groups. The study's findings were analyzed using the SPSS software.
- Conditions
- Metabolic Syndrome, Protection Against
- Being tested
- Nutritionally balanced low-calorie diet
- Keywords
- Nutritionally balanced low-calorie diet, Archipelago diet, Metabolic biomarkers
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritionally balanced low-calorie dietOther
Dietary interventions were given with a calorie deficit of 500-600 kcal from the participants' usual daily intake.
| Study group | Role | What they receive |
|---|---|---|
| Nutritionally balanced low-calorie diet | Experimental | Experimental study with pre and post design Receives: Other: Nutritionally balanced low-calorie diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline body mass index at 8 weeks.
A person's weight in kilograms divided by the square of height in meters
Measured: up to 8 weeks
Change from baseline waist circumference at 8 weeks.
The measurement taken around the abdomen at the level of the umbilicus (belly button).
Measured: up to 8 weeks
Change from baseline systolic and diastolic blood pressure at 8 weeks.
Measured using a digital sphygmomanometer
Measured: up to 8 weeks
Change from baseline fat mass percentage at 8 weeks.
Measured using bioimpedance analysis (BIA)
Measured: up to 8 weeks
Change from baseline fasting blood sugar levels at 8 weeks.
Measured using clinical chemistry analyzer
Measured: up to 8 weeks
Change from baseline lipid profile levels at 8 weeks.
The lipid profile examined included total cholesterol, triglycerides, HDL (high density lipoprotein) cholesterol, and LDL (low density lipoprotein) cholesterol. Measured using clinical chemistry analyzer (photometer).
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start5 Aug 2022
- Primary completion4 Dec 2022
- Study completion4 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metabolic Syndrome, Protection AgainstStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study was conducted by providing a daily calorie deficit of 500-600 kcal to the usual intake of each participant. The study was conducted for 8 weeks. Examination of metabolic biomarkers is carried out before and after the diet intervention is administered.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andalas University
- Sponsor type
- University, hospital or other
- Collaborators
- Universitas Sumatera Utara, Hasanuddin University
- Responsible party
- Principal investigator, Nur Indrawaty Lipoeto, Andalas University
- Investigators
- Nurindrawaty Lipoeto, PhD, Principal investigator, Universitas Andalas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05703438
- Sponsor's protocol ID
- RKI2022
- Status last verified
- Jan 2023
- First submitted
- 5 Dec 2022
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
Han TS, Lean ME. A clinical perspective of obesity, metabolic syndrome and cardiovascular disease. JRSM Cardiovasc Dis. 2016 Feb 25;5:2048004016633371. doi: 10.1177/2048004016633371. eCollection 2016 Jan-Dec.
PubMed 26998259Witjaksono F, Jutamulia J, Annisa NG, Prasetya SI, Nurwidya F. Comparison of low calorie high protein and low calorie standard protein diet on waist circumference of adults with visceral obesity and weight cycling. BMC Res Notes. 2018 Sep 21;11(1):674. doi: 10.1186/s13104-018-3781-z.
PubMed 30241565
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Nutritionally Balanced Low Calorie Diet Based on Traditional Indonesian Foods on Obese People's Metabolic Biomarkers
- ClinicalTrials.gov ID
- NCT05703438
- Acronym / sponsor ID
- RKI2022
- Conditions
- Metabolic Syndrome, Protection Against
- Keywords
- Nutritionally balanced low-calorie diet, Archipelago diet, Metabolic biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Andalas UniversityUniversity, hospital or other
- Collaborators
- Universitas Sumatera Utara, Hasanuddin University
- Study start
- 5 Aug 2022 (actual)
- Primary completion
- 4 Dec 2022 (actual)
- Study completion
- 4 Dec 2022 (actual)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The research was carried out at RSUP dr. M. Djamil Padang. The research ethics commission of Andalas University's Faculty of Medicine granted the study an ethical permit. Health workers with a BMI of more than 25 kg/m2 became the study population, and officers who agreed to participate in the study after filling out the informed consent form were included in the study. There were 91 people in the study. The study lasted eight weeks (56 days). A week before the study, participants were interviewed about their daily intake using 24-hour food recall, and anthropometric measurements were taken using calibrated tools and performed by trained officers.
Subjects underwent a one-week pre-treatment period (baseline period, beginning on D-day 6 and ending on D-day 0), during which they were asked not to take any supplements. All participants had their anthropometric measurement, blood pressure, body fat percentage, fasting blood sugar levels, and lipid profile checked on day 0 and day 57.
The Nutrisurvey 2005 application was used to process the daily intake of participants obtained from a 24-hour food recall interview. Dietary interventions were given with a calorie deficit of 500-600 kcal from the participants' usual daily intake. A Minangkabau food menu is provided as part of the diet. Participants are given a list of daily menus, which include breakfast, lunch, and dinner. Researchers provided lunch for study participants, while breakfast and dinner were prepared independently by participants using the dietary guidelines and menus provided. Participants kept a food diary, which was collected and evaluated twice a week. The research team also controls and motivates all participants via Whatsapp groups. The study's findings were analyzed using the SPSS software.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study was conducted by providing a daily calorie deficit of 500-600 kcal to the usual intake of each participant. The study was conducted for 8 weeks. Examination of metabolic biomarkers is carried out before and after the diet intervention is administered.
| Arm | Type | Receives |
|---|---|---|
| Nutritionally balanced low-calorie diet | Experimental | Other: Nutritionally balanced low-calorie dietExperimental study with pre and post design |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritionally balanced low-calorie dietDietary interventions were given with a calorie deficit of 500-600 kcal from the participants' usual daily intake. | Other | Nutritionally balanced low-calorie diet |
Primary outcome
Change from baseline body mass index at 8 weeks.
Time frame: up to 8 weeks
A person's weight in kilograms divided by the square of height in meters
Change from baseline waist circumference at 8 weeks.
Time frame: up to 8 weeks
The measurement taken around the abdomen at the level of the umbilicus (belly button).
Change from baseline systolic and diastolic blood pressure at 8 weeks.
Time frame: up to 8 weeks
Measured using a digital sphygmomanometer
Change from baseline fat mass percentage at 8 weeks.
Time frame: up to 8 weeks
Measured using bioimpedance analysis (BIA)
Change from baseline fasting blood sugar levels at 8 weeks.
Time frame: up to 8 weeks
Measured using clinical chemistry analyzer
Change from baseline lipid profile levels at 8 weeks.
Time frame: up to 8 weeks
The lipid profile examined included total cholesterol, triglycerides, HDL (high density lipoprotein) cholesterol, and LDL (low density lipoprotein) cholesterol. Measured using clinical chemistry analyzer (photometer).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Background: PubMed 26998259Han TS, Lean ME. A clinical perspective of obesity, metabolic syndrome and cardiovascular disease. JRSM Cardiovasc Dis. 2016 Feb 25;5:2048004016633371. doi: 10.1177/2048004016633371. eCollection 2016 Jan-Dec.
- Results publication: PubMed 30241565Witjaksono F, Jutamulia J, Annisa NG, Prasetya SI, Nurwidya F. Comparison of low calorie high protein and low calorie standard protein diet on waist circumference of adults with visceral obesity and weight cycling. BMC Res Notes. 2018 Sep 21;11(1):674. doi: 10.1186/s13104-018-3781-z.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nurindrawaty Lipoeto, PhD principal investigator
Universitas Andalas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritionally balanced low-calorie diet in people with Metabolic Syndrome, Protection Against, run by Andalas University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline body mass index at 8 weeks. (time frame: up to 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05703438, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.