The Effect of Fermented and Non-fermented Soy Based Food in Appetite and Satiety Biomarker Among Young Obesity
Primary Purpose
Obesity, Abdominal, Weight Loss
Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
meal test response
Sponsored by
About this trial
This is an interventional prevention trial for Obesity, Abdominal focused on measuring tempeh, appetite, satiety, obesity
Eligibility Criteria
Inclusion Criteria:
- BMI > 25 kg/m2
- female
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
Sites / Locations
- Etika Ratna Noer
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
tempeh steak
soybean steak
Arm Description
The subjects were received the tempeh steak meal with isocal diet containing energy 307.4Kcal
The subjects were received the soybean steak meal with isocal diet containing energy 307.4Kcal
Outcomes
Primary Outcome Measures
change acylated ghrelin
Change acyl ghrelin at 0, 30, and 180 minutes from venous blood, taken after meal intake
change glucose
Change glucose at 0, 30, and 180 minutes from venous blood, taken after meal intake
change arginine
Change arginine at 0, 30, and 180 minutes from venous blood, taken after meal intake
change insulin
Change insulin at 0, 30, and 180 minutes from venous blood, taken after meal intake
Visual Analogue scale (VAS)
VAS measure hunger/fullness at the same time points that blood samples were taken throughout the study protocol (ie. 0, 30, 180 minutes)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04425109
Brief Title
The Effect of Fermented and Non-fermented Soy Based Food in Appetite and Satiety Biomarker Among Young Obesity
Official Title
Department of Nutrition Science, Medical Faculty, Universitas Diponegoro Semarang, Indonesia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitas Diponegoro
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
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
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.
2.2. Preparation of Meal Diets The ingredient contents of the tempeh steak and soybean steak are listed. Tempeh Steak including : Tempeh 100g, 50g potato, 50g carrot and 50g green peas. Soybean Steak : Soybean 100g, 50g potato, 50g carrot, 50g green peas. The energy content of both are 307.4 Calorie (21.7g Protein, 8g Fat, 42.3g Carbohydrate, 4.5g fiber)
2.3. Anthropometric measurement Body weight, height, and body fat mass, lean mass, andfat-freemass were collected by a bioelectric impedance analyzer (SECA). BMI was calculated as body weight in kilograms divided by height in meters squared (kg/m2). Waist Circumference (WC) was measured with ainelastic measuring tape aroundthe mid-section between the margin of the last rib and the iliac crest.
2.4. Biochemical analysis Blood samples were collected from subjects'forearms. Venous blood specimens were collected in EDTA-treated and plain tubes after a 12-h fast. Blood samples were collected at 0 (fasting), 60, and 180mins. One tube containing EDTA was collected for acyl ghrelin analyses and plain tube collected for arginine, glucose, and insulin analyses. The tubes were centrifuged at 3000 × g for 10 minutesat 4°C, separated into plasma or serum, and stored at -80°C untilanalysis. Serum concentrations of acyl ghrelin, insulin and arginine were measured using an enzyme-linked immunosorbent assay (ELISA)
2.5. Scoring of subjective satiety usingvisual analogue scales (VAS) Visual Analogue Scales Food intake motivation was assessed with 100 mm line. Participants completed VAS to measure hunger/fullness at the same time points that blood samples were taken throughout the study protocol (ie. 0, 30, 180 minutes). The VAS questionnaire provides a subjective assessment of appetite-related sensations over time and allows the relationship between biochemical and dietary intake data to be explored. Visual analogue scales have been found to be a reliable and valid method to assess subjective states related to food intake behavior. On each of the test days, participants were asked to rate the following components relating to hunger and satiety using various questions, scored using the VAS instrument: (1) Hunger: how hungry do you feel at this moment? (VAS1) (2) The desire to eat: how strong is your desire to eat at this moment? (VAS5- VAS8); (3) Fullness: how full does your stomach feel at this moment? (VAS2, VAS3); (4) Motivation to eat: how much food do you think you could eat at this moment? (VAS4)
2.6 Statistical Analysis Data were analyzed IBM SPSS. Variable not normally distributed were nonparametric test. Wann whitney U test was used to test for difference all parameter at baseline. We compared change in variable (baseline, 30, 180 minutes) in each sub group using pair t=test or wilcoxon signed rank test to determine the impact of differential change. To test for change in parameters between two group used kruskal wallis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Abdominal, Weight Loss
Keywords
tempeh, appetite, satiety, obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Group 1 : give tempeh steak Group 2 : give soybean steak washout 3 days Group 1 : give soybean steak Group 2 : give tempeh steak
Masking
ParticipantInvestigator
Masking Description
subject with random allocation Investigator do not know the group the analysator do not know the group
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tempeh steak
Arm Type
Experimental
Arm Description
The subjects were received the tempeh steak meal with isocal diet containing energy 307.4Kcal
Arm Title
soybean steak
Arm Type
Experimental
Arm Description
The subjects were received the soybean steak meal with isocal diet containing energy 307.4Kcal
Intervention Type
Behavioral
Intervention Name(s)
meal test response
Intervention Description
soy fermented versus non fermented meal test
Primary Outcome Measure Information:
Title
change acylated ghrelin
Description
Change acyl ghrelin at 0, 30, and 180 minutes from venous blood, taken after meal intake
Time Frame
1 days
Title
change glucose
Description
Change glucose at 0, 30, and 180 minutes from venous blood, taken after meal intake
Time Frame
1 days
Title
change arginine
Description
Change arginine at 0, 30, and 180 minutes from venous blood, taken after meal intake
Time Frame
1 days
Title
change insulin
Description
Change insulin at 0, 30, and 180 minutes from venous blood, taken after meal intake
Time Frame
1 days
Title
Visual Analogue scale (VAS)
Description
VAS measure hunger/fullness at the same time points that blood samples were taken throughout the study protocol (ie. 0, 30, 180 minutes)
Time Frame
1 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BMI > 25 kg/m2
female
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Etika Noer
Organizational Affiliation
Universitas Diponegoro
Official's Role
Principal Investigator
Facility Information:
Facility Name
Etika Ratna Noer
City
Semarang
State/Province
Central Java
ZIP/Postal Code
50275
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
the result of this study is available to cite everyone
IPD Sharing Time Frame
anytime
IPD Sharing Access Criteria
etikaratna@fk.undip.ac.id
IPD Sharing URL
http://dept-gizi@fk.undip.ac.id
Citations:
PubMed Identifier
34147377
Citation
Noer ER, Dewi L, Kuo CH. Fermented soybean enhances post-meal response in appetite-regulating hormones among Indonesian girls with obesity. Obes Res Clin Pract. 2021 Jul-Aug;15(4):339-344. doi: 10.1016/j.orcp.2021.06.005. Epub 2021 Jun 17.
Results Reference
derived
Learn more about this trial
The Effect of Fermented and Non-fermented Soy Based Food in Appetite and Satiety Biomarker Among Young Obesity
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