跳至主要内容
临床试验/NCT05703438
NCT05703438已完成不适用

The Effect of a Nutritionally Balanced Low Calorie Diet Based on Traditional Indonesian Foods on Obese People's Metabolic Biomarkers

Andalas University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年8月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Change from baseline fat mass percentage at 8 weeks.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Change from baseline fat mass percentage at 8 weeks.

时间窗: up to 8 weeks

Measured using bioimpedance analysis (BIA)

Change from baseline body mass index at 8 weeks.

时间窗: up to 8 weeks

A person's weight in kilograms divided by the square of height in meters

Change from baseline systolic and diastolic blood pressure at 8 weeks.

时间窗: up to 8 weeks

Measured using a digital sphygmomanometer

Change from baseline fasting blood sugar levels at 8 weeks.

时间窗: up to 8 weeks

Measured using clinical chemistry analyzer

Change from baseline waist circumference at 8 weeks.

时间窗: up to 8 weeks

The measurement taken around the abdomen at the level of the umbilicus (belly button).

Change from baseline lipid profile levels at 8 weeks.

时间窗: 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).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nur Indrawaty Lipoeto

Clinical Professor

Andalas University

研究点 (1)

Loading locations...

相似试验