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临床试验/NCT04425109
NCT04425109已完成不适用

Department of Nutrition Science, Medical Faculty, Universitas Diponegoro Semarang, Indonesia

Universitas Diponegoro2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2018年6月1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
13
试验地点
2
主要终点
change acylated ghrelin

研究概览

简要总结

Limited data are available regarding the satiety effects from fermented and non-fermented soy-based food. The aim of this study was to compare fermented (tempeh) and non-fermented soy-based diets high in protein in increasing satiety. Thirteen young obese females were studied in single-blind and cross over design. Blood samples were assessed frequently for 0, 30 and 120 minutes after consumption of two isocaloric breakfast which consist of tempeh and non-fermented soybean content. The energy content was 27% protein, 21% fat and 52% carbohydrate. Subjective satiety score was recorded at 30 and 120 minutes after taking a meal. Compared to non-fermented soybean, tempeh showed a steady trend in postprandial ghrelin, significantly increasing insulin and arginine, and decreasing glucose at 120 minutes. Satiety scores had the same trend in the hunger and fullness aspects between the meals.

详细描述

  1. Introduction Obesity is a complex metabolic condition thought to result from an imbalance in energy intake and energy expenditure that results in excess fat accumulation in various adipose tissues and organs. It has been proposed that managing the dietary composition may be an efficient way to reduce body weight.

Ghrelin is a circulating orexigenic hormone involved in both short-term food intake control at single meal. Protein has the most suppressive effect as opposed to other macronutrients on food intake. It has also been shown that dietary protein induces greater satiation and weight loss than carbohydrates. Postprandial ghrelin and insulin responses have been shown to be lower in high dietary protein Soybeans provide one of the most plentiful dietary protein sources for plants varies from 36% to 56%. Soy protein is a complete protein since it contains most of the important amino acids found in animal proteins.

Limited evidence from soybean related satiety study suggests that tempeh may have an important role in obesity prevention and weight loss through satiating effects when replacing other protein foods in a mixed diet.

Thus far, there have been only limited data regarding the satiety effects of dietary soy protein vs fermented soy protein on obesity in humans. The study aimed to examine the effect of anorexigenic hormone response and subjective satiety underfermented and isocaloric soy-based protein diet 2. Methods and Matherials

2.1. Subjects The subjects were recruited from advertisement who were motivated enough to respond actively to the request for topics. We used the following exclusion criteria: 1) a clinically significant history of chronic diseases, such as cardiovascular disease, diabetes, dyslipidemia or hypertension; 2) use of a weight-related medication/food; 3) heavy alcohol/drug consumption; and 4) pregnancy, breastfeeding, or intention to become pregnant during the time of the study. The subjects were divided into the TD, which were given tempeh, and SD, which were given soy, groups, to receive the meal than a crossover. All subjects signed a written consent form before participating in the studies, which were approved by Kariadi Hospital-Medical Faculty of Diponegoro University.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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 21 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • BMI > 25 kg/m2

排除标准

  • clinically significant history of chronic diseases, such as cardiovascular disease, diabetes, dyslipidemia or hypertension
  • use of a weight-related medication/food;
  • heavy alcohol/drug consumption;
  • pregnancy and breastfeeding

结局指标

主要结局

change acylated ghrelin

时间窗: 1 days

Change acyl ghrelin at 0, 30, and 180 minutes from venous blood, taken after meal intake

Visual Analogue scale (VAS)

时间窗: 1 days

VAS measure hunger/fullness at the same time points that blood samples were taken throughout the study protocol (ie. 0, 30, 180 minutes)

change glucose

时间窗: 1 days

Change glucose at 0, 30, and 180 minutes from venous blood, taken after meal intake

change arginine

时间窗: 1 days

Change arginine at 0, 30, and 180 minutes from venous blood, taken after meal intake

change insulin

时间窗: 1 days

Change insulin at 0, 30, and 180 minutes from venous blood, taken after meal intake

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

Etika Ratna Noer

Department of Nutrition, Medical Faculty

Universitas Diponegoro

研究点 (2)

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