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

Sponsor

National Taiwan Normal University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05290519

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity, Abdominal Glycation End Products, Advanced Inflammation Gut Microbiota	Other: plant and animal protein	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A plant protein for 4 weeks than animal protein for 4 weeks	Other: plant and animal protein plant protein: 2 bottle of black soy milk (400 mL/bottle) for 4 weeks animal protein: pork dished for 4 weeks
Experimental: Group B animal protein for 4 weeks than plant protein for 4 weeks	Other: plant and animal protein plant protein: 2 bottle of black soy milk (400 mL/bottle) for 4 weeks animal protein: pork dished for 4 weeks

Arm

Intervention/Treatment

Experimental: Group A

plant protein for 4 weeks than animal protein for 4 weeks

Other: plant and animal protein

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

Experimental: Group B

animal protein for 4 weeks than plant protein for 4 weeks

Other: plant and animal protein

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

Outcome Measures

Primary Outcome Measures

change from 4week blood advanced glycation end products level at 8 week [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 [12, 16 week]
blood AGEs level will be measured before and after intervention
change from 4 week blood leptin level at 8 week [4, 8 week]
blood leptin level will be measured before and after intervention
change from 12 week blood leptin level at 16 week [12, 16 week]
blood leptin level will be measured before and after intervention
change from 4 week blood adiponectin level at 8 week [4, 8 week]
blood leptin level will be measured before and after intervention
change from 12 week blood adiponectin level at 16 week [12, 16 week]
blood leptin level will be measured before and after intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 64 Years

Sexes Eligible for Study:

All

Accepts 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