The Effect of Diet Counseling for Low Calorie-High Protein on the Body Composition (Weight, Body Mass Index, Fat Mass (kg), Fat Mass Percentage, Muscle Mass (kg), Muscle Mass Percentage, Inflammation Marker (High-sensitivity C-reactive Protein), and Oxidative Stress Marker (Malondialdehyde and Glutathione) in Obese People With Weight Cycling in Jakarta
试验速览
- 阶段
- 不适用
- 入组人数
- 54
- 试验地点
- 4
- 主要终点
- body weight
研究概览
简要总结
The world prevalence of obesity in adult population in 2014 was nearly 13% while in Indonesia, it has reached 32.9% in the same year. Obesity is an established risk factors for cardiovascular diseases. A large proportion of people who had succeeded to reduce body weight failed to maintain it (weight cycling). Studies were inconclusive about the best composition in the diet for such people to have a better life quality and reduce risk factors from non-communicable disease. The purpose of this research was to evaluate the body composition changes, Inflammation marker and oxidative stress marker changes resulted from low calorie high protein and standard protein diet programme in obese people with history of weight cycling.
This is an open-randomized clinical trial of weight loss program as a part of a larger study researching the effect of low calorie high protein diet to body composition, oxidative stress, inflammation marker and metabolic syndrome in obese with weight cycling. Subjects were assigned to low calorie diet and were randomly distributed into two intervention groups, namely high protein group (22-30 % of total calories intake) and standard protein group (12-20%). Anthropometry, body composition data, and blood sample (for inflammation marker (HsCRP) and oxidative stress (malondialdehyde and glutathione)) were taken at baseline and at the end of the study. Subjects were followed up to 8 weeks with daily reminder and weekly counselling
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •body mass index ranging from 25 - 35 kg/m2
- •history of weight loss ≥2 kg and regaining weight into or exceeding its initial body weight at least twice in last five years
排除标准
- •diabetes mellitus
- •history of gastrointestinal tract resection
- •hormonal disorders
- •using hormonal contraception
- •menopause,
- •kidney function disruption
研究组 & 干预措施
high protein
High protein (HP) group were given counseling about weight loss program by applying low calorie-high protein diet with diet menu composition of 22-30% protein, along with instructions for allowed cooking method.
干预措施: diet counseling (Behavioral)
standard protein
Active comparator receiving standard protein (SP) proportion were counseled about weight loss program by means of low calorie-balanced composition diet with menu comprised of 12-20% protein.
干预措施: diet counseling (Behavioral)
结局指标
主要结局
body weight
时间窗: eight weeks
body weight analyzed by body composition monitors with advanced bioelectrical impedance analysis (BIA) principle expressed in kilogram (kg) unit
body mass index
时间窗: eight weeks
a weight-to-height ratio, calculated by dividing one's weight in kilograms by the square of one's height in meters analyzed by body composition monitors with advanced bioelectrical impedance analysis (BIA) principle expressed in kilogram per meter squared (kg/m\^2) unit
fat mass
时间窗: eight weeks
actual weight of fat in one's body analyzed by body composition monitors with advanced bioelectrical impedance analysis (BIA) principle expressed in kilogram (kg) unit
fat mass percentage
时间窗: eight weeks
the proportion of fat to the total body weight analyzed by body composition monitors with advanced bioelectrical impedance analysis (BIA) principle expressed as percentage (%)
muscle mass
时间窗: eight weeks
The predicted weight of muscle in one's body analyzed by body composition monitors with advanced bioelectrical impedance analysis (BIA) principle expressed in kilogram (kg) unit
muscle mass percentage
时间窗: eight weeks
The predicted proportion of muscle weight to the total body weight analyzed by body composition monitors with advanced bioelectrical impedance analysis (BIA) principle expressed in kilogram (kg) unit
Inflammation marker (high-sensitivity C-reactive protein)
时间窗: eight weeks
indicator of inflammation state measured by Immunochemiluminescent (Immulite 1000) device
plasma malondialdehyde level
时间窗: eight weeks
the concentration of malondialdehyde (1,3-Propanedial) in the plasma as an oxidative stress marker measured by means of Will's method expressed in nmol/ml plasma unit
plasma gluthatione level
时间窗: eight weeks
the concentration of glutathione ((2S)-2-Amino-4-{\[(1R)-1-\[(carboxymethyl)carbamoyl\]-2-sulfanylethyl\]carbamoyl}butanoic acid) as an endogenous antioxidant compound in the plasma measured by means of Ellman's method expressed in µg/ml plasma unit
次要结局
- days of compliance(eight weeks)
- mean caloric intake(eight weeks)
- mean percentage of caloric intake from protein(eight weeks)
研究者
Fiastuti Witjaksono
Principal Invdstigator
Indonesia University