Obesity, AbdominalNCT05290519
Comparison of Plant-based or Animal-based Protein on Anthropocentric and Metabolic Parameters in Obese Subjects
A study testing plant and animal protein in people with Obesity, Abdominal and Glycation End Products, Advanced, run by National Taiwan Normal University at 1 site in Taiwan.
Trial summary
The investigators will try to evaluate the effects of substitution of dietary animal protein by black soybean milk (400 mL x 2) per day on anthropocentric and metabolic parameters in obese subjects. Read more about this study
- Who is it for?
- Ages 20 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Abdominal, Glycation End Products, Advanced, Inflammation
- What is being tested?
- plant and animal protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2022to 31 Dec 2022
- 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 20 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20 to 64 year male or female
- 27 <= BMI < 35 or waist circumference male >= 90 cm/female >= 80 cm
- fasting blood glucose: 100-125 mg/dL
Who cannot join
- Hypertension, cardiovascular disease, endocrine disease, acute and chronic liver and kidney disease, mental disease, binge or anorexia, or long-term drug use
- Consume probiotics, prebiotics, antibiotics or weight loss drugs regularly for the past month
- Try to lose weight and do resistance exercise regularly for the past month
- Allergic to soy products
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan Normal University
Taipei, 106
Shu-Man Pan, 886277491903, ntnurec@gmail.com
About this study
The investigators will try to evaluate the effects of substitution of dietary animal protein by black soybean milk (400 mL x 2) per day on anthropocentric and metabolic parameters in obese subjects.
Read the detailed description
According to the survey by the Ministry of Health and Welfare, the proportion of obese male adolescents in Taiwan has been increasing year by year. Obesity is associated with chronic low-grade inflammation. Obese people prefer to intake foods containing higher levels of advanced glycation end products (AGEs). High intake of dietary AGEs (dAGEs) results in abdominal obesity, and shows positive correlation with body mass index (BMI) and waist circumference. When a large amount of AGEs accumulates in the body, inflammation usually occurs. Therefore, reducing dAGEs intake prevents the incidence of obesity, chronic diseases and aging. Black beans are high in protein. The black bean coats contain high level of anthocyanins. Previous studies demonstrated the biological functions of anthocyanins on blood lipid regulation, inflammation, and also inhibition of AGEs formation. Compared with meat (beef, pork, lamb, chicken, and seafood), the plant protein source, soy milk, under the same protein content showed significantly lower dAGE. In this study, the investigators will try to eveluate the effects of substitution of dietary animal protein by black soybean milk (400 mL x 2) per day on anthropocentric and metabolic parameters in obese subjects. This will be a randomized crossover interventional trial for 16 weeks: 0 to 4 weeks will be run-in period, 4 to 8 weeks and 12 to 16 weeks will be the soy milk or meat intervention period, and the between of two interventions (8 to 12 weeks) will be washout period. The body composition, blood pressure and AGE level will be measured. The blood, urine and feces sample will be collected for biochemical analysis and gut microbiome. The investigators expect the results could support the promotion of plant protein as part of dietary protein source to improve abnormal anthropometric and metabolic parameters in obese subjects.
- Being tested
- plant and animal protein
- Keywords
- advanced glycation end products, obesity, plant protein, inflammation, gut microbiota
- Medical subject headings
- Obesity, Abdominal, Inflammation, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plant and animal proteinOther
plant protein: 2 bottle of black soy milk (400 mL/bottle) for 4 weeks animal protein: pork dished for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | plant protein for 4 weeks than animal protein for 4 weeks Receives: Other: plant and animal protein |
| Group B | Experimental | animal protein for 4 weeks than plant protein for 4 weeks Receives: Other: plant and animal protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from 4week blood advanced glycation end products level at 8 week
blood AGEs level will be measured before and after intervention
Measured: 4, 8 week
change from 12 week blood advanced glycation end products level at 16 week
blood AGEs level will be measured before and after intervention
Measured: 12, 16 week
change from 4 week blood leptin level at 8 week
blood leptin level will be measured before and after intervention
Measured: 4, 8 week
change from 12 week blood leptin level at 16 week
blood leptin level will be measured before and after intervention
Measured: 12, 16 week
change from 4 week blood adiponectin level at 8 week
blood leptin level will be measured before and after intervention
Measured: 4, 8 week
change from 12 week blood adiponectin level at 16 week
blood leptin level will be measured before and after intervention
Measured: 12, 16 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start1 Mar 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wan-Ju Yeh, Principal investigator, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05290519
- Sponsor's protocol ID
- NTNU
- Status last verified
- Mar 2022
- First submitted
- 1 Mar 2022
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be published in journals
Publications
Chang YH, Lee PN, Chen CH, Yang HY, Wu CH, Doong JY, Yeh WJ. Substituting animal protein with black soymilk reduces advanced glycation end product level and improves gut microbiota composition in obese prediabetic individuals: a randomized crossover intervention trial. Food Funct. 2025 Jan 2;16(1):195-206. doi: 10.1039/d4fo04717f.
PubMed 39651546
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Plant-based or Animal-based Protein on Anthropocentric and Metabolic Parameters in Obese Subjects
- ClinicalTrials.gov ID
- NCT05290519
- Acronym / sponsor ID
- NTNU
- Keywords
- advanced glycation end products, obesity, plant protein, inflammation, gut microbiota
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan Normal UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 22 Mar 2022 (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.
The investigators will try to evaluate the effects of substitution of dietary animal protein by black soybean milk (400 mL x 2) per day on anthropocentric and metabolic parameters in obese subjects.
Detailed description
According to the survey by the Ministry of Health and Welfare, the proportion of obese male adolescents in Taiwan has been increasing year by year. Obesity is associated with chronic low-grade inflammation. Obese people prefer to intake foods containing higher levels of advanced glycation end products (AGEs). High intake of dietary AGEs (dAGEs) results in abdominal obesity, and shows positive correlation with body mass index (BMI) and waist circumference. When a large amount of AGEs accumulates in the body, inflammation usually occurs. Therefore, reducing dAGEs intake prevents the incidence of obesity, chronic diseases and aging. Black beans are high in protein. The black bean coats contain high level of anthocyanins. Previous studies demonstrated the biological functions of anthocyanins on blood lipid regulation, inflammation, and also inhibition of AGEs formation. Compared with meat (beef, pork, lamb, chicken, and seafood), the plant protein source, soy milk, under the same protein content showed significantly lower dAGE. In this study, the investigators will try to eveluate the effects of substitution of dietary animal protein by black soybean milk (400 mL x 2) per day on anthropocentric and metabolic parameters in obese subjects. This will be a randomized crossover interventional trial for 16 weeks: 0 to 4 weeks will be run-in period, 4 to 8 weeks and 12 to 16 weeks will be the soy milk or meat intervention period, and the between of two interventions (8 to 12 weeks) will be washout period. The body composition, blood pressure and AGE level will be measured. The blood, urine and feces sample will be collected for biochemical analysis and gut microbiome. The investigators expect the results could support the promotion of plant protein as part of dietary protein source to improve abnormal anthropometric and metabolic parameters in obese subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: plant and animal proteinplant protein for 4 weeks than animal protein for 4 weeks |
| Group B | Experimental | Other: plant and animal proteinanimal protein for 4 weeks than plant protein for 4 weeks |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 20 to 64 year male or female
- 27 <= BMI < 35 or waist circumference male >= 90 cm/female >= 80 cm
- fasting blood glucose: 100-125 mg/dL
Key exclusion criteria (4 listed)
- Hypertension, cardiovascular disease, endocrine disease, acute and chronic liver and kidney disease, mental disease, binge or anorexia, or long-term drug use
- Consume probiotics, prebiotics, antibiotics or weight loss drugs regularly for the past month
- Try to lose weight and do resistance exercise regularly for the past month
- Allergic to soy products
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 |
|---|---|---|
| plant and animal proteinplant protein: 2 bottle of black soy milk (400 mL/bottle) for 4 weeks animal protein: pork dished for 4 weeks | Other | Group A, Group B |
Primary outcome
change from 4week blood advanced glycation end products level at 8 week
Time frame: 4, 8 week
blood AGEs level will be measured before and after intervention
change from 12 week blood advanced glycation end products level at 16 week
Time frame: 12, 16 week
blood AGEs level will be measured before and after intervention
change from 4 week blood leptin level at 8 week
Time frame: 4, 8 week
blood leptin level will be measured before and after intervention
change from 12 week blood leptin level at 16 week
Time frame: 12, 16 week
blood leptin level will be measured before and after intervention
change from 4 week blood adiponectin level at 8 week
Time frame: 4, 8 week
blood leptin level will be measured before and after intervention
change from 12 week blood adiponectin level at 16 week
Time frame: 12, 16 week
blood leptin level will be measured before and after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Derived from this study: PubMed 39651546Chang YH, Lee PN, Chen CH, Yang HY, Wu CH, Doong JY, Yeh WJ. Substituting animal protein with black soymilk reduces advanced glycation end product level and improves gut microbiota composition in obese prediabetic individuals: a randomized crossover intervention trial. Food Funct. 2025 Jan 2;16(1):195-206. doi: 10.1039/d4fo04717f.
- Individual participant dataSharing planned: No. IPD will be published in journals
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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.
Wan-Ju Yeh principal investigator
National Taiwan Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing plant and animal protein in people with Obesity, Abdominal and Glycation End Products, Advanced, run by National Taiwan Normal University at 1 site in Taiwan.
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 3 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: status not confirmed, as of the sponsor's last update on 22 Mar 2022. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wan-Ju Yeh (886277496988, wandayeh@ntnu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from 4week blood advanced glycation end products level at 8 week (time frame: 4, 8 week). The study lists 6 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 NCT05290519, 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 22 Mar 2022.