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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05290519
• Other study ID #: NTNU
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2022
• Source: National Taiwan Normal University
• Contact: Wan-Ju Yeh
• Phone: 886277496988
• Email: wandayeh[@]ntnu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Gut Microbiota
• Inflammation
• Obesity, Abdominal

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Taiwan Normal University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan Normal University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from 4week blood advanced glycation end products level at 8 week	blood AGEs level will be measured before and after intervention	4, 8 week
Primary	change from 12 week blood advanced glycation end products level at 16 week	blood AGEs level will be measured before and after intervention	12, 16 week
Primary	change from 4 week blood leptin level at 8 week	blood leptin level will be measured before and after intervention	4, 8 week
Primary	change from 12 week blood leptin level at 16 week	blood leptin level will be measured before and after intervention	12, 16 week
Primary	change from 4 week blood adiponectin level at 8 week	blood leptin level will be measured before and after intervention	4, 8 week
Primary	change from 12 week blood adiponectin level at 16 week	blood leptin level will be measured before and after intervention	12, 16 week