Department of Nutrition Science, Medical Faculty, Universitas Diponegoro Semarang, Indonesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- change acylated ghrelin
研究概览
简要总结
Obesity has been reported to impair regulation of appetite and lead uncontrollably hunger and satiety response. Ghrelin is orexigenic hormone from the stomach meanwhile, leptin is anorexigenic from adipose. Interestingly, obesity is associated with acylated ghrelin and leptin resistance. Study about the impact of high protein and fiber with combined exercise (HPFE) to suppress hunger among young obese still unclear. The hypothesis was that high protein-fiber would result in decreased in acylated ghrelin and leptin in HPFE group. Thus, the investigator examined the effect of an 8 weeks HPFE on acylated ghrelin and leptin. Subjects were randomized into four groups: High Protein-Fiber (HPF; n=15). High Protein-Fiber and exercise (HPFE; n=15), Exercise (E; n=15) and control (C; n=15). The diet prescribed 1200 kcal/day, based on basic energy requirement minus 300kcal, consisted high protein (25%) and fiber (30g/day). The exercise is combination aerobic and resistance training, with target 75% heart rate maximum. Plasma acylated ghrelin and leptin were analyzed with enzyme immunoassay.
详细描述
- Introduction Obesity pandemic occurred in both developed and developing countries. The prevalence of young obesity is rising among adolescents in developing countries as well, rising from 8.1% to 12.9% in 2013 for boys and from 8.4% to 13.4% in girls. The Indonesian Basic Health Research showed prevalence of young obesity in Indonesia increase from 18,8 menjadi 31% on 2007 till 2018. The prominent problem with young obesity is the accumulation of adipose cells in the abdominal which can interfere with appetite hormones. Ghrelin is the only known as orexigenic hormon which secreted from the stomach. The leptin is one of anorexigenic mainly released by the adipose tissue. The orexigenic hormone acylated ghrelin and the anorexigenic hormones leptin are an important players in regulating appetite, food intake, energy balance, and adipogenesis.
Regarding body weight regulation, key element are the control of energy intake which is regulated at the simplest level by sensation of hunger. Body weight is controlled by a complex system, including both peripheral and central factors. Two of the hormones that appear to play a crucial role in the regulation of food intake and body weight are leptin and ghrelin. Interestingly, obesity is associated with acylated ghrelin and leptin resistance. Hyperleptinemia is blunted response in satiety. Postprandial acylated ghrelin levels in obesity abdominal subjects do not fall, so hunger still appears. In obese subjects experience leptin resistance because the leptin receptor is disrupted so that there is a failure of sending leptin signals to the hypothalamus. Many study especially about acylated ghrelin still controversial. Studi Andarini showed plasma AG concentration is higher before and after eating at all time points, regardless of food type, in obese individuals, as compared with normal weight individuals. Consistant with the Ozkan et al reveal the AG increase following obesity status.
Different types of protein can result in different levels of satiety. Metabolites, including certain amino acids, contribute to the food intake is arginine. The ability of specific L-amino acids, including L-arginine (L-Arg), to stimulate anorectic agent (GLP-1 and PYY) release has been studied previously in vitro. The study Alamshah et al showed L-Arg reduced food intake and stimulated gut hormone release in rodents. The role fiber affect the release satiety and gastric emptying rate.
Managing weight loss with modification lifestyle in young obesity actually requires paying special attention to high compliance and less hunger more satiety. The study aimed to examine the effect of giving a high protein diet rich arginine and fiber diet with exercise among adolescent obesity. 2. Methods and Matherials 2.1 Participants The program was conducted from Juli to Oktober 2018. Subject were recruited through nutrition screening and campaign mass media. For sample size, the investigator calculated previous studies regarding AG with following setting: power was set at 80%, p value at 0.5 and standardized difference was 21.2, resulting in a sampel size of 12 subjects, including 20% for drop out. Inclusion criteria are body mass index > 25 kg/m2, waist circumference >80 cm for female and >90 cm for male. The investigator exclude who were taking dietary supplements or medication, smokers, have pregnancy, lose body weight > 10% before treatment and have chronic disease history. The participants consisted of 60 adolescents obesity who were selected from outpatient of Universitas Diponegoro, Semarang, Indonesia. Subjects were randomized into four groups : High Protein-Fiber (HPF; n=15). High Protein-Fiber and exercise (HPFE; n=15), Exercise (E; n=15) and control (C; n=15). All participants has signed informed consent and the study was approved by Kariadi Hospital-Diponegoro University with provision Declaration of Helsinki (Number 427/EC/FK-UNDIP/VII/2018)
2.1 Study design and randomization. The study design was randomized clinical trial (four-arm). The random assignment was generated by a computerized program. The duration of intervention is 8 weeks. It was not possible to blind the dietitians who advised on dietary prescribe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
subject with random allocation Investigator do not know the group the analysator do not know the group
入排标准
- 年龄范围
- 19 Years 至 20 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •body mass index > 25 kg/m2,
- •waist circumference >80 cm for female and >90 cm for male
排除标准
- •taking dietary supplements or medication
- •have pregnancy
- •lose body weight > 10% before treatment
- •have chronic disease history
结局指标
主要结局
change acylated ghrelin
时间窗: 8 weeks
Change from Baseline acyl ghrelin at 8 weeks taken in the lab from venous blood specimen after10h fasting using ELISA method
change body weight
时间窗: 8 weeks
change from baseline body weight at 8 weeks measured using bioelectrical impedance analysis (BIA) with light clothes and no shoes
change leptin
时间窗: 8 weeks
Change from Baseline leptin at 8 weeks taken in the lab from venous blood specimen after10h fasting using ELISA method
次要结局
- change triglyceride(8 weeks)
- change high density lipoprotein(8 weeks)
研究者
Etika Ratna Noer
Department of Nutrition, Medical Faculty
Universitas Diponegoro
