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

NCT05290519 | Unknown

• 1 other identifier: NTNU
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Group A

EXPERIMENTAL

plant protein for 4 weeks than animal protein for 4 weeks

Other: plant and animal protein

Group B

EXPERIMENTAL

animal protein for 4 weeks than plant protein for 4 weeks

Other: plant and animal protein

Interventions

plant and animal protein OTHER

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

Group A; Group B

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• to 64 year male or female
• \<= BMI \< 35 or waist circumference male \>= 90 cm/female \>= 80 cm
• fasting blood glucose: 100-125 mg/dL

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan Normal University: lead

Study Sites (1)

National Taiwan Normal University

Taipei, 106, Taiwan

RECRUITING

Related Publications (1)

• Chang YH, Lee PN, Chen CH, Yang HY, Wu CH, Doong JY, Yeh WJ. Substituting animal protein with black soymilk reduces advanced glycation end product level and improves gut microbiota composition in obese prediabetic individuals: a randomized crossover intervention trial. Food Funct. 2025 Jan 2;16(1):195-206. doi: 10.1039/d4fo04717f.

  PMID: 39651546 DERIVED

MeSH Terms

Conditions

Obesity, Abdominal; Inflammation; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Wan-Ju Yeh

  National Taiwan Normal University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wan-Ju Yeh

CONTACT

886277496988; wandayeh@ntnu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: March 22, 2022
• Study Start: March 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)