Nusantara Diet (Balance Nutrition With Low Calorie and Low Sodium Diet) Impact on Body Composition, Insulin Resistance, and Lipid Profile in Patients With Risk of Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Body Mass Index
研究概览
简要总结
The goal of this randomized clinical trial is to evaluate the effect of Nusantara Diet (Low Calorie and Low Sodium) for Metabolic Syndrome. The main questions it aims to answer are:
- How effective the Nusantara diet in reducing body mass index and body fat percentage?
- How effective the Nusantara diet in affecting lipid profile and insulin resistance?
Participants will be given this diet for a period of 56 days and undergo repeated outcome measurement. This study has a comparison group (no intervention) to see the difference of reduction or slope of changes in outcomes. We assumed that the Nusantara diet will reduce the metabolic syndrome indicators (anthropometry, lipid profile, and insulin resistance profile).
详细描述
Design
a. Randomized controlled trial with pre-post design
Intervention :
- Balance Nutrition with low calorie and low sodium. Low calorie means a diet with 500 kilocalories lower than the Basal Energy Expenditure, according to the Harris-Benedict formula. The daily limit of sodium is 2300 mg.
- Organoleptic test for set menu
- Given as a set for 56 days
- Dietary counseling is given before intervention, followed by a 24-hour food recall every week.
Outcome
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
masking is not feasible according to the study design.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fulfill the definition of metabolic syndrome
- •Blood Pressure>135/85 mmHg
- •Central obesity with waist circumference for males>90 cm or >80 cm in females
- •Triglyceride level >150 mg/dL, followed by HDL<40 mg/dL
- •blood fasting glucose >100 mg/dL
排除标准
- •pregnant or breastfeeding women
- •suffer from chronic disease
研究组 & 干预措施
Intervention
This group will receive dietary adjustment and nutrition counseling.
干预措施: Diet Nusantara (Dietary Supplement)
Intervention
This group will receive dietary adjustment and nutrition counseling.
干预措施: Nutrition Counseling (Behavioral)
Control
This group will receive standard diet and nutrition counseling.
干预措施: Nutrition Counseling (Behavioral)
结局指标
主要结局
Body Mass Index
时间窗: changes of body mass index from baseline to day 56
Defined as body weight in kilogram defined by square of body height in meter. Higher number indicates obesity
Lipid profile
时间窗: changes of lipid profile from baseline to day 56
parameters of lipid (total cholesterol, LDL, HDL, Triglyceride) measured from blood sample
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
时间窗: changes of HOMA-IR from baseline to day 56
HOMA-IR was calculated according to the formula: fasting insulin x fasting glucose/22.5.
Body Fat Percentage
时间窗: changes of Body Fat Percentage from baseline to day 56
Body Fat Percentage is the total mass of fat divided by total body mass, multiplied by 100. This is measured by Bioelectrical Impedance Analyzer.
次要结局
未报告次要终点
研究者
Bumi Herman
Assistant Lecturer
Hasanuddin University