Obesity, AbdominalNCT04425109
The Effect of Fermented and Non-fermented Soy Based Food in Appetite and Satiety Biomarker Among Young Obesity
A study testing meal test response in people with Obesity, Abdominal and Weight Loss, run by Universitas Diponegoro at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 21 years, women only
- Conditions the study is for
- Obesity, Abdominal, Weight Loss
- What is being tested?
- meal test response
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jun 2018to 31 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 21 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- BMI > 25 kg/m2
- female
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Department of Nutrition Science, Medical Faculty, Universitas Diponegoro Semarang, Indonesia
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.
Read the 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.
- Conditions
- Obesity, Abdominal, Weight Loss
- Being tested
- meal test response
- Keywords
- tempeh, appetite, satiety, obesity
- Medical subject headings
- Obesity, Abdominal, Weight Loss, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
meal test responseBehavioural
soy fermented versus non fermented meal test
| Study group | Role | What they receive |
|---|---|---|
| tempeh steak | Experimental | The subjects were received the tempeh steak meal with isocal diet containing energy 307.4Kcal Receives: Behavioral: meal test response |
| soybean steak | Experimental | The subjects were received the soybean steak meal with isocal diet containing energy 307.4Kcal Receives: Behavioral: meal test response |
What is being measured
The primary outcome is the main question the study is designed to answer.
change acylated ghrelin
Change acyl ghrelin at 0, 30, and 180 minutes from venous blood, taken after meal intake
Measured: 1 days
change glucose
Change glucose at 0, 30, and 180 minutes from venous blood, taken after meal intake
Measured: 1 days
change arginine
Change arginine at 0, 30, and 180 minutes from venous blood, taken after meal intake
Measured: 1 days
change insulin
Change insulin at 0, 30, and 180 minutes from venous blood, taken after meal intake
Measured: 1 days
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)
Measured: 1 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Jun 2018
- Primary completion31 Jul 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity, AbdominalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Diponegoro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Etika Ratna Noer, Universitas Diponegoro
- Investigators
- Etika Noer, Principal investigator, Universitas Diponegoro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425109
- Sponsor's protocol ID
- SOY
- Status last verified
- Jun 2020
- First submitted
- 29 May 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the result of this study is available to cite everyone
Publications
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.
PubMed 34147377
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Nutrition Science, Medical Faculty, Universitas Diponegoro Semarang, Indonesia
- ClinicalTrials.gov ID
- NCT04425109
- Acronym / sponsor ID
- SOY
- Conditions
- Obesity, Abdominal, Weight Loss
- Keywords
- tempeh, appetite, satiety, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Universitas DiponegoroUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| tempeh steak | Experimental | Behavioral: meal test responseThe subjects were received the tempeh steak meal with isocal diet containing energy 307.4Kcal |
| soybean steak | Experimental | Behavioral: meal test responseThe subjects were received the soybean steak meal with isocal diet containing energy 307.4Kcal |
Who may qualify
- Ages
- 19 to 21 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI > 25 kg/m2
- female
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| meal test responsesoy fermented versus non fermented meal test | Behavioural | soybean steak, tempeh steak |
Primary outcome
change acylated ghrelin
Time frame: 1 days
Change acyl ghrelin at 0, 30, and 180 minutes from venous blood, taken after meal intake
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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Derived from this study: PubMed 34147377Noer 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.
- Individual participant dataSharing planned: Yes. the result of this study is available to cite everyone
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Etika Noer principal investigator
Universitas Diponegoro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing meal test response in people with Obesity, Abdominal and Weight Loss, run by Universitas Diponegoro at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change acylated ghrelin (time frame: 1 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04425109, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.