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Comparison of Plant-based or Animal-based Protein on Anthropocentric and Metabolic Parameters in Obese Subjects

Comparison of Plant-based or Animal-based Protein on Anthropocentric and Metabolic Parameters in Obese Subjects

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05290519
Enrollment
30
Registered
2022-03-22
Start date
2022-03-01
Completion date
2022-12-31
Last updated
2022-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glycation End Products, Advanced, Gut Microbiota, Inflammation, Obesity, Abdominal

Keywords

advanced glycation end products, obesity, plant protein, inflammation, gut microbiota

Brief 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.

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.

Interventions

OTHERplant and animal protein

plant protein: 2 bottle of black soy milk (400 mL/bottle) for 4 weeks animal protein: pork dished for 4 weeks

Sponsors

National Taiwan Normal University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 64 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
change from 4week blood advanced glycation end products level at 8 week4, 8 weekblood AGEs level will be measured before and after intervention
change from 12 week blood advanced glycation end products level at 16 week12, 16 weekblood AGEs level will be measured before and after intervention
change from 4 week blood leptin level at 8 week4, 8 weekblood leptin level will be measured before and after intervention
change from 12 week blood leptin level at 16 week12, 16 weekblood leptin level will be measured before and after intervention
change from 4 week blood adiponectin level at 8 week4, 8 weekblood leptin level will be measured before and after intervention
change from 12 week blood adiponectin level at 16 week12, 16 weekblood leptin level will be measured before and after intervention

Countries

Taiwan

Contacts

Primary ContactWan-Ju Yeh
wandayeh@ntnu.edu.tw886277496988

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026