Comparison of Plant-based or Animal-based Protein on Anthropocentric and Metabolic Parameters in Obese Subjects
Primary Purpose
Obesity, Abdominal, Glycation End Products, Advanced, Inflammation
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
plant and animal protein
Sponsored by
About this trial
This is an interventional prevention trial for Obesity, Abdominal focused on measuring advanced glycation end products, obesity, plant protein, inflammation, gut microbiota
Eligibility Criteria
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
Sites / Locations
- National Taiwan Normal UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A
Group B
Arm Description
plant protein for 4 weeks than animal protein for 4 weeks
animal protein for 4 weeks than plant protein for 4 weeks
Outcomes
Primary Outcome Measures
change from 4week blood advanced glycation end products level at 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
blood AGEs level will be measured before and after intervention
change from 4 week blood leptin level at 8 week
blood leptin level will be measured before and after intervention
change from 12 week blood leptin level at 16 week
blood leptin level will be measured before and after intervention
change from 4 week blood adiponectin level at 8 week
blood leptin level will be measured before and after intervention
change from 12 week blood adiponectin level at 16 week
blood leptin level will be measured before and after intervention
Secondary Outcome Measures
Full Information
NCT ID
NCT05290519
First Posted
March 1, 2022
Last Updated
March 13, 2022
Sponsor
National Taiwan Normal University
1. Study Identification
Unique Protocol Identification Number
NCT05290519
Brief Title
Comparison of Plant-based or Animal-based Protein on Anthropocentric and Metabolic Parameters in Obese Subjects
Official Title
Comparison of Plant-based or Animal-based Protein on Anthropocentric and Metabolic Parameters in Obese Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan Normal University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Abdominal, Glycation End Products, Advanced, Inflammation, Gut Microbiota
Keywords
advanced glycation end products, obesity, plant protein, inflammation, gut microbiota
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
plant protein for 4 weeks than animal protein for 4 weeks
Arm Title
Group B
Arm Type
Experimental
Arm Description
animal protein for 4 weeks than plant protein for 4 weeks
Intervention Type
Other
Intervention Name(s)
plant and animal protein
Intervention Description
plant protein: 2 bottle of black soy milk (400 mL/bottle) for 4 weeks animal protein: pork dished for 4 weeks
Primary Outcome Measure Information:
Title
change from 4week blood advanced glycation end products level at 8 week
Description
blood AGEs level will be measured before and after intervention
Time Frame
4, 8 week
Title
change from 12 week blood advanced glycation end products level at 16 week
Description
blood AGEs level will be measured before and after intervention
Time Frame
12, 16 week
Title
change from 4 week blood leptin level at 8 week
Description
blood leptin level will be measured before and after intervention
Time Frame
4, 8 week
Title
change from 12 week blood leptin level at 16 week
Description
blood leptin level will be measured before and after intervention
Time Frame
12, 16 week
Title
change from 4 week blood adiponectin level at 8 week
Description
blood leptin level will be measured before and after intervention
Time Frame
4, 8 week
Title
change from 12 week blood adiponectin level at 16 week
Description
blood leptin level will be measured before and after intervention
Time Frame
12, 16 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wan-Ju Yeh
Phone
886277496988
Email
wandayeh@ntnu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wan-Ju Yeh
Organizational Affiliation
National Taiwan Normal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan Normal University
City
Taipei
ZIP/Postal Code
106
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shu-Man Pan
Phone
886277491903
Email
ntnurec@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD will be published in journals
Learn more about this trial
Comparison of Plant-based or Animal-based Protein on Anthropocentric and Metabolic Parameters in Obese Subjects
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