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

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammation; Obesity, Abdominal; Gut Microbiota; Glycation End Products, Advanced
• Intervention / Treatment: Other: plant and animal protein

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wan-Ju Yeh; Phone Number: 886277496988; Email: wandayeh@ntnu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 106
    • Recruiting
    • National Taiwan Normal University
    • Contact: Shu-Man Pan; Phone Number: 886277491903; Email: ntnurec@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
change from 4 week blood leptin level at 8 week	blood leptin level will be measured before and after intervention	4, 8 week
change from 12 week blood leptin level at 16 week	blood leptin level will be measured before and after intervention	12, 16 week
change from 4 week blood adiponectin level at 8 week	blood leptin level will be measured before and after intervention	4, 8 week
change from 12 week blood adiponectin level at 16 week	blood leptin level will be measured before and after intervention	12, 16 week

Collaborators and Investigators

• Sponsor: National Taiwan Normal University
• Investigators: Principal Investigator: Wan-Ju Yeh, National Taiwan Normal University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: March 1, 2022
• First Submitted That Met QC Criteria: March 13, 2022
• First Posted (Actual): March 22, 2022

Study Record Updates

• Last Update Posted (Actual): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 13, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: obesity; inflammation; gut microbiota; plant protein; advanced glycation end products
• Additional Relevant MeSH Terms: Pathologic Processes; Overnutrition; Nutrition Disorders; Obesity; Inflammation; Obesity, Abdominal
• Other Study ID Numbers: NTNU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will be published in journals

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No