Clinical trial NCT05703438: The Effect of a Low-calorie Diet With Balanced Nutrition on Metabolic Syndrome
Official title: The Effect of a Nutritionally Balanced Low Calorie Diet Based on Traditional Indonesian Foods on Obese People's Metabolic Biomarkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome, Protection Against
Keywords: Nutritionally balanced low-calorie diet
Archipelago diet
Metabolic biomarkers
Lead sponsor: Andalas University
Sponsor class: OTHER
Collaborators: name: Universitas Sumatera Utara
name: Hasanuddin University
First posted: 2023-01-30
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline body mass index at 8 weeks.
timeFrame: up to 8 weeks
measure: Change from baseline waist circumference at 8 weeks.
timeFrame: up to 8 weeks
measure: Change from baseline systolic and diastolic blood pressure at 8 weeks.
timeFrame: up to 8 weeks
measure: Change from baseline fat mass percentage at 8 weeks.
timeFrame: up to 8 weeks
measure: Change from baseline fasting blood sugar levels at 8 weeks.
timeFrame: up to 8 weeks
measure: Change from baseline lipid profile levels at 8 weeks.
timeFrame: up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Padang
country: Indonesia
facility: Universitas Andalas
state: Sumatera Barat
Study officials:
affiliation: Universitas Andalas
name: Nurindrawaty Lipoeto, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Witjaksono 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.