Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06525441
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
Dietary Protein Sources and Glycemic Variability
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Impact of Dietary Protein Sources on Glycemic Variability in Overweight or Obese Individuals a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ProG
Brief Summary:
This goal of trial is to evaluate the effects of plant-based vs animal-based diets on glycemic variability in overweight or obese adults through a 3-week dietary intervention
The main question it aims to answer is
Will a plant-based diet be able to reduce glycemic variability in overweight or obese adults compared with an animal-based diet
Participants will strictly follow a designated plant-based or animal-based dietary regimen throughout the duration of the 3-week study They will wear a Continuous Glucose Monitor CGM throughout the study engage in weekly clinical assessments and record their daily dietary intake
The main question it aims to answer is
Will a plant-based diet be able to reduce glycemic variability in overweight or obese adults compared with an animal-based diet
Participants will strictly follow a designated plant-based or animal-based dietary regimen throughout the duration of the 3-week study They will wear a Continuous Glucose Monitor CGM throughout the study engage in weekly clinical assessments and record their daily dietary intake
Detailed Description:
Diabetes stands as one of the most rapidly escalating health challenges of the 21st century Type 2 diabetes which represents over 90 of all diagnosed cases is the predominant form of the disease with obesity and being overweight identified as key risk factors The mainstay of prevention and management for Type 2 diabetes continues to be dietary intervention and nutritional therapy Current dietary strategies for Type 2 diabetes focus predominantly on the regulation of fat and carbohydrate intake while the influence and underlying mechanisms of dietary protein on glucose metabolism are not yet fully comprehended
A randomized open-label parallel-controlled clinical trial by strictly controlling the source of protein will be performed to evaluate the effects of a plant-based diet on glycemic variability and other metabolic outcomes in individuals who are overweight or obese in comparison to an animal-based diet Eligible participants will be randomly allocated in a 11 ratio to either the plant-based or animal-based diet group for a 3-week intervention
During the intervention participants in the plant-based diet group will receive three daily meals for three weeksOf the energy of each meal 60 is from carbohydrates 15 from plant protein and 25 from fat The primary sources of plant protein will include soybeans lentils nuts grains and seaweed Conversely the animal-based diet group will also be provided with three daily meals for three weeks with the same caloric distribution but sourcing their protein from animal products such as poultry beef pork fish eggs and dairy
Participants are required to cooperate in completing the following tasks
1 Daily dietary record Participants are to meticulously track their daily food consumption
2 Continuous 24-hour glucose monitoring and data logging Subjects are to undergo continuous monitoring of blood glucose levels throughout a 24-hour period with all data accurately recorded
3 Physical examination This will include assessments of height weight waist-to-hip circumference ratio blood pressure and body composition
4 Biological sample collection Samples to be collected include blood urine and stool
The timing for physical examinations and biological sample collections is scheduled as follows Day 5 2 of the introduction phase Week 1 2 days of the intervention phase Week 2 2 days of the intervention phase and Week 3 2 days of the intervention phase
Dietary and health counseling will be consistently available throughout the study to provide participants with continuous support and guidance
A randomized open-label parallel-controlled clinical trial by strictly controlling the source of protein will be performed to evaluate the effects of a plant-based diet on glycemic variability and other metabolic outcomes in individuals who are overweight or obese in comparison to an animal-based diet Eligible participants will be randomly allocated in a 11 ratio to either the plant-based or animal-based diet group for a 3-week intervention
During the intervention participants in the plant-based diet group will receive three daily meals for three weeksOf the energy of each meal 60 is from carbohydrates 15 from plant protein and 25 from fat The primary sources of plant protein will include soybeans lentils nuts grains and seaweed Conversely the animal-based diet group will also be provided with three daily meals for three weeks with the same caloric distribution but sourcing their protein from animal products such as poultry beef pork fish eggs and dairy
Participants are required to cooperate in completing the following tasks
1 Daily dietary record Participants are to meticulously track their daily food consumption
2 Continuous 24-hour glucose monitoring and data logging Subjects are to undergo continuous monitoring of blood glucose levels throughout a 24-hour period with all data accurately recorded
3 Physical examination This will include assessments of height weight waist-to-hip circumference ratio blood pressure and body composition
4 Biological sample collection Samples to be collected include blood urine and stool
The timing for physical examinations and biological sample collections is scheduled as follows Day 5 2 of the introduction phase Week 1 2 days of the intervention phase Week 2 2 days of the intervention phase and Week 3 2 days of the intervention phase
Dietary and health counseling will be consistently available throughout the study to provide participants with continuous support and guidance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None