<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04425109</url>
  </required_header>
  <id_info>
    <org_study_id>SOY</org_study_id>
    <nct_id>NCT04425109</nct_id>
  </id_info>
  <brief_title>The Effect of Fermented and Non-fermented Soy Based Food in Appetite and Satiety Biomarker Among Young Obesity</brief_title>
  <official_title>Department of Nutrition Science, Medical Faculty, Universitas Diponegoro Semarang, Indonesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitas Diponegoro</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitas Diponegoro</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Limited data are available regarding the satiety effects from fermented and non-fermented&#xD;
      soy-based food. The aim of this study was to compare fermented (tempeh) and non-fermented&#xD;
      soy-based diets high in protein in increasing satiety. Thirteen young obese females were&#xD;
      studied in single-blind and cross over design. Blood samples were assessed frequently for 0,&#xD;
      30 and 120 minutes after consumption of two isocaloric breakfast which consist of tempeh and&#xD;
      non-fermented soybean content. The energy content was 27% protein, 21% fat and 52%&#xD;
      carbohydrate. Subjective satiety score was recorded at 30 and 120 minutes after taking a&#xD;
      meal. Compared to non-fermented soybean, tempeh showed a steady trend in postprandial&#xD;
      ghrelin, significantly increasing insulin and arginine, and decreasing glucose at 120&#xD;
      minutes. Satiety scores had the same trend in the hunger and fullness aspects between the&#xD;
      meals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Introduction Obesity is a complex metabolic condition thought to result from an&#xD;
           imbalance in energy intake and energy expenditure that results in excess fat&#xD;
           accumulation in various adipose tissues and organs. It has been proposed that managing&#xD;
           the dietary composition may be an efficient way to reduce body weight.&#xD;
&#xD;
           Ghrelin is a circulating orexigenic hormone involved in both short-term food intake&#xD;
           control at single meal. Protein has the most suppressive effect as opposed to other&#xD;
           macronutrients on food intake. It has also been shown that dietary protein induces&#xD;
           greater satiation and weight loss than carbohydrates. Postprandial ghrelin and insulin&#xD;
           responses have been shown to be lower in high dietary protein Soybeans provide one of&#xD;
           the most plentiful dietary protein sources for plants varies from 36% to 56%. Soy&#xD;
           protein is a complete protein since it contains most of the important amino acids found&#xD;
           in animal proteins.&#xD;
&#xD;
           Limited evidence from soybean related satiety study suggests that tempeh may have an&#xD;
           important role in obesity prevention and weight loss through satiating effects when&#xD;
           replacing other protein foods in a mixed diet.&#xD;
&#xD;
           Thus far, there have been only limited data regarding the satiety effects of dietary soy&#xD;
           protein vs fermented soy protein on obesity in humans. The study aimed to examine the&#xD;
           effect of anorexigenic hormone response and subjective satiety underfermented and&#xD;
           isocaloric soy-based protein diet&#xD;
&#xD;
        2. Methods and Matherials&#xD;
&#xD;
      2.1. Subjects The subjects were recruited from advertisement who were motivated enough to&#xD;
      respond actively to the request for topics. We used the following exclusion criteria: 1) a&#xD;
      clinically significant history of chronic diseases, such as cardiovascular disease, diabetes,&#xD;
      dyslipidemia or hypertension; 2) use of a weight-related medication/food; 3) heavy&#xD;
      alcohol/drug consumption; and 4) pregnancy, breastfeeding, or intention to become pregnant&#xD;
      during the time of the study. The subjects were divided into the TD, which were given tempeh,&#xD;
      and SD, which were given soy, groups, to receive the meal than a crossover. All subjects&#xD;
      signed a written consent form before participating in the studies, which were approved by&#xD;
      Kariadi Hospital-Medical Faculty of Diponegoro University.&#xD;
&#xD;
      2.2. Preparation of Meal Diets The ingredient contents of the tempeh steak and soybean steak&#xD;
      are listed. Tempeh Steak including : Tempeh 100g, 50g potato, 50g carrot and 50g green peas.&#xD;
      Soybean Steak : Soybean 100g, 50g potato, 50g carrot, 50g green peas. The energy content of&#xD;
      both are 307.4 Calorie (21.7g Protein, 8g Fat, 42.3g Carbohydrate, 4.5g fiber)&#xD;
&#xD;
      2.3. Anthropometric measurement Body weight, height, and body fat mass, lean mass,&#xD;
      andfat-freemass were collected by a bioelectric impedance analyzer (SECA). BMI was calculated&#xD;
      as body weight in kilograms divided by height in meters squared (kg/m2). Waist Circumference&#xD;
      (WC) was measured with ainelastic measuring tape aroundthe mid-section between the margin of&#xD;
      the last rib and the iliac crest.&#xD;
&#xD;
      2.4. Biochemical analysis Blood samples were collected from subjects'forearms. Venous blood&#xD;
      specimens were collected in EDTA-treated and plain tubes after a 12-h fast. Blood samples&#xD;
      were collected at 0 (fasting), 60, and 180mins. One tube containing EDTA was collected for&#xD;
      acyl ghrelin analyses and plain tube collected for arginine, glucose, and insulin analyses.&#xD;
      The tubes were centrifuged at 3000 × g for 10 minutesat 4°C, separated into plasma or serum,&#xD;
      and stored at -80°C untilanalysis. Serum concentrations of acyl ghrelin, insulin and arginine&#xD;
      were measured using an enzyme-linked immunosorbent assay (ELISA)&#xD;
&#xD;
      2.5. Scoring of subjective satiety usingvisual analogue scales (VAS) Visual Analogue Scales&#xD;
      Food intake motivation was assessed with 100 mm line. Participants completed VAS to measure&#xD;
      hunger/fullness at the same time points that blood samples were taken throughout the study&#xD;
      protocol (ie. 0, 30, 180 minutes). The VAS questionnaire provides a subjective assessment of&#xD;
      appetite-related sensations over time and allows the relationship between biochemical and&#xD;
      dietary intake data to be explored. Visual analogue scales have been found to be a reliable&#xD;
      and valid method to assess subjective states related to food intake behavior. On each of the&#xD;
      test days, participants were asked to rate the following components relating to hunger and&#xD;
      satiety using various questions, scored using the VAS instrument: (1) Hunger: how hungry do&#xD;
      you feel at this moment? (VAS1) (2) The desire to eat: how strong is your desire to eat at&#xD;
      this moment? (VAS5- VAS8); (3) Fullness: how full does your stomach feel at this moment?&#xD;
      (VAS2, VAS3); (4) Motivation to eat: how much food do you think you could eat at this moment?&#xD;
      (VAS4)&#xD;
&#xD;
      2.6 Statistical Analysis Data were analyzed IBM SPSS. Variable not normally distributed were&#xD;
      nonparametric test. Wann whitney U test was used to test for difference all parameter at&#xD;
      baseline. We compared change in variable (baseline, 30, 180 minutes) in each sub group using&#xD;
      pair t=test or wilcoxon signed rank test to determine the impact of differential change. To&#xD;
      test for change in parameters between two group used kruskal wallis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Actual">August 31, 2018</completion_date>
  <primary_completion_date type="Actual">July 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_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</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>subject with random allocation Investigator do not know the group the analysator do not know the group</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>change acylated ghrelin</measure>
    <time_frame>1 days</time_frame>
    <description>Change acyl ghrelin at 0, 30, and 180 minutes from venous blood, taken after meal intake</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change glucose</measure>
    <time_frame>1 days</time_frame>
    <description>Change glucose at 0, 30, and 180 minutes from venous blood, taken after meal intake</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change arginine</measure>
    <time_frame>1 days</time_frame>
    <description>Change arginine at 0, 30, and 180 minutes from venous blood, taken after meal intake</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change insulin</measure>
    <time_frame>1 days</time_frame>
    <description>Change insulin at 0, 30, and 180 minutes from venous blood, taken after meal intake</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Analogue scale (VAS)</measure>
    <time_frame>1 days</time_frame>
    <description>VAS measure hunger/fullness at the same time points that blood samples were taken throughout the study protocol (ie. 0, 30, 180 minutes)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Obesity, Abdominal</condition>
  <condition>Weight Loss</condition>
  <arm_group>
    <arm_group_label>tempeh steak</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subjects were received the tempeh steak meal with isocal diet containing energy 307.4Kcal</description>
  </arm_group>
  <arm_group>
    <arm_group_label>soybean steak</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subjects were received the soybean steak meal with isocal diet containing energy 307.4Kcal</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>meal test response</intervention_name>
    <description>soy fermented versus non fermented meal test</description>
    <arm_group_label>soybean steak</arm_group_label>
    <arm_group_label>tempeh steak</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI &gt; 25 kg/m2&#xD;
&#xD;
          -  female&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  clinically significant history of chronic diseases, such as cardiovascular disease,&#xD;
             diabetes, dyslipidemia or hypertension&#xD;
&#xD;
          -  use of a weight-related medication/food;&#xD;
&#xD;
          -  heavy alcohol/drug consumption;&#xD;
&#xD;
          -  pregnancy and breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Etika Noer</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitas Diponegoro</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Etika Ratna Noer</name>
      <address>
        <city>Semarang</city>
        <state>Central Java</state>
        <zip>50275</zip>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Indonesia</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 7, 2020</last_update_submitted>
  <last_update_submitted_qc>June 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitas Diponegoro</investigator_affiliation>
    <investigator_full_name>Etika Ratna Noer</investigator_full_name>
    <investigator_title>Department of Nutrition, Medical Faculty</investigator_title>
  </responsible_party>
  <keyword>tempeh</keyword>
  <keyword>appetite</keyword>
  <keyword>satiety</keyword>
  <keyword>obesity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Obesity, Abdominal</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>the result of this study is available to cite everyone</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>anytime</ipd_time_frame>
    <ipd_access_criteria>etikaratna@fk.undip.ac.id</ipd_access_criteria>
    <ipd_url>http://dept-gizi@fk.undip.ac.id</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04425109
org study id: SOY
nct id: NCT04425109
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.

      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.
allocation: Randomized
intervention model: Crossover Assignment
intervention 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
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
measure: change acylated ghrelin
time frame: 1 days
description: Change acyl ghrelin at 0, 30, and 180 minutes from venous blood, taken after meal intake
measure: change glucose
time frame: 1 days
description: Change glucose at 0, 30, and 180 minutes from venous blood, taken after meal intake
measure: change arginine
time frame: 1 days
description: Change arginine at 0, 30, and 180 minutes from venous blood, taken after meal intake
measure: change insulin
time frame: 1 days
description: Change insulin at 0, 30, and 180 minutes from venous blood, taken after meal intake
measure: Visual Analogue scale (VAS)
time frame: 1 days
description: VAS measure hunger/fullness at the same time points that blood samples were taken throughout the study protocol (ie. 0, 30, 180 minutes)
arm group label: tempeh steak
arm group type: Experimental
description: The subjects were received the tempeh steak meal with isocal diet containing energy 307.4Kcal
arm group label: soybean steak
arm group type: Experimental
description: The subjects were received the soybean steak meal with isocal diet containing energy 307.4Kcal
intervention type: Behavioral
intervention name: meal test response
description: soy fermented versus non fermented meal test
arm group label: soybean steak
arm group label: tempeh steak
criteria: 
gender: Female
minimum age: 19 Years
maximum age: 21 Years
healthy volunteers: No
last name: Etika Noer
role: Principal Investigator
affiliation: Universitas Diponegoro
facility: 
country: Indonesia
responsible party type: Principal Investigator
investigator affiliation: Universitas Diponegoro
investigator full name: Etika Ratna Noer
investigator title: Department of Nutrition, Medical Faculty
mesh term: Obesity
mesh term: Obesity, Abdominal
mesh term: Weight Loss
sharing ipd: Yes
ipd description: the result of this study is available to cite everyone
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: anytime
ipd access criteria: etikaratna@fk.undip.ac.id
ipd url: http://dept-gizi@fk.undip.ac.id