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Clinical Trials/NCT04425109
NCT04425109CompletedNot Applicable

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

Universitas Diponegoro1 site in 1 country13 target enrollmentStarted: June 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
13
Locations
1
Primary Endpoint
change acylated ghrelin

Study Overview

Brief Summary

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.

Detailed Description

  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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Masking Description

subject with random allocation Investigator do not know the group the analysator do not know the group

Eligibility Criteria

Ages
19 Years to 21 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •BMI > 25 kg/m2

Exclusion Criteria

  • •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

Arms & Interventions

tempeh steak

Experimental

The subjects were received the tempeh steak meal with isocal diet containing energy 307.4Kcal

Intervention: meal test response (Behavioral)

soybean steak

Experimental

The subjects were received the soybean steak meal with isocal diet containing energy 307.4Kcal

Intervention: meal test response (Behavioral)

Outcomes

Primary Outcomes

change acylated ghrelin

Time Frame: 1 days

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

Visual Analogue scale (VAS)

Time Frame: 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

Time Frame: 1 days

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

change arginine

Time Frame: 1 days

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

change insulin

Time Frame: 1 days

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Etika Ratna Noer

Department of Nutrition, Medical Faculty

Universitas Diponegoro

Study Sites (1)

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