Ignite Creation Date:
2024-05-06 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05903625
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-12-27
First Post:
2023-05-24
Brief Title:
Effect of Lysine and Phosphorus Fortification on Glycemic Index and Postprandial Glycemia in Double Fortified Bread
Sponsor:
University of Veterinary and Animal Sciences Lahore - Pakistan
Organization:
University of Veterinary and Animal Sciences Lahore - Pakistan
Study Overview
Official Title:
Effect of Lysine and Phosphorous in Double Fortified Bread on Glycemic Index GI of White Bread and Postprandial Glycemia
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LP-DFB-GI-PG
Brief Summary:
The goal of this clinical trial is to investigate the effect of lysine and phosphorous on the glycemic index GI of white bread and postprandial glycemia The main questions it aims to answer are
Can double fortification with lysine and phosphorous lower the glycemic index GI of bread
Does double fortification with lysine and phosphorous improve postprandial glycemia
Participants in the study will be assigned to the control group where they will consume regular white bread then to the experimental group where they will consume double fortified bread with lysine and phosphorous The glycemic response of the bread samples will be measured by monitoring blood glucose levels in healthy participants after consuming the bread The glycemic index will also be calculated based on the area under the curve AUC of the test food compared to a standard The collected data will be analyzed using statistical methods such as paired sample t-tests and one-way ANOVA
The expected outcomes of the study are that lysine and phosphorous will reduce the glycemic index of white bread and also decrease the postprandial blood glucose spike This research aims to provide valuable insights into fortifying bread to improve its health impact particularly for individuals with diabetes or at risk of developing diabetes
Can double fortification with lysine and phosphorous lower the glycemic index GI of bread
Does double fortification with lysine and phosphorous improve postprandial glycemia
Participants in the study will be assigned to the control group where they will consume regular white bread then to the experimental group where they will consume double fortified bread with lysine and phosphorous The glycemic response of the bread samples will be measured by monitoring blood glucose levels in healthy participants after consuming the bread The glycemic index will also be calculated based on the area under the curve AUC of the test food compared to a standard The collected data will be analyzed using statistical methods such as paired sample t-tests and one-way ANOVA
The expected outcomes of the study are that lysine and phosphorous will reduce the glycemic index of white bread and also decrease the postprandial blood glucose spike This research aims to provide valuable insights into fortifying bread to improve its health impact particularly for individuals with diabetes or at risk of developing diabetes
Detailed Description:
This study aims to investigate the effect of lysine and phosphorous in double fortified bread on the glycemic index GI of white bread and postprandial glycemia The research will be conducted through a human trial involving 16 participants The study protocol includes the objectives design methods scientific background and statistical considerations
The objective of the study is to evaluate the impact of lysine and phosphorous fortification on the glycemic response to bread consumption The study will employ a interventional study design with four intervention groups The participants will be assigned into Group 1 simple white bread Group 2 lysine fortified bread Group 3 phosphorous fortified bread and Group 4 lysine and phosphorous fortified bread
To ensure accurate measurements the study will involve multiple readings at different time intervals Blood glucose levels will be measured at 15 minutes 30 minutes 45 minutes 90 and 120 minutes after consuming the bread Each experiment will be conducted for a single group on a specific date Each experiment will be repeated with a three-day gap between each repetition This schedule ensures that each group receives the intervention on separate days and allows for sufficient time between experiments to minimize any carryover effects or potential confounding factors Baseline fasting blood glucose levels will also be assessed before consuming the test foods
The primary outcomes of the study are the glycemic index GI and postprandial glycemia The glycemic index will be calculated through incremental area under the curve iAUC of the test food to that of standard food The iAUC values will be compared between the intervention groups to assess the effects of lysine and phosphorous fortification on glycemic response
The statistical analysis plan will include descriptive statistics to summarize participant characteristics and baseline variables Statistical tests such as analysis of variance ANOVA or non-parametric equivalent tests will be used to compare the intervention groups
The time frame for the study will focus on the immediate post-meal period typically within 2 hour to evaluate the acute effects of the bread interventions on blood glucose levels The study protocol takes into account ethical considerations participant recruitment informed consent data collection procedures and data analysis methods
The scientific background of the study includes a review of existing literature on the effects of lysine and phosphorous on glycemic response It provides a rationale for investigating the specific research question and highlights the potential implications of the study findings
Overall the study protocol outlines a rigorous and systematic approach to investigate the effect of lysine and phosphorous fortification on the glycemic index and postprandial glycemia of white bread The detailed description ensures clarity and transparency in the research methodology allowing researchers participants and data users to understand the objectives design methods and statistical considerations of the study
The objective of the study is to evaluate the impact of lysine and phosphorous fortification on the glycemic response to bread consumption The study will employ a interventional study design with four intervention groups The participants will be assigned into Group 1 simple white bread Group 2 lysine fortified bread Group 3 phosphorous fortified bread and Group 4 lysine and phosphorous fortified bread
To ensure accurate measurements the study will involve multiple readings at different time intervals Blood glucose levels will be measured at 15 minutes 30 minutes 45 minutes 90 and 120 minutes after consuming the bread Each experiment will be conducted for a single group on a specific date Each experiment will be repeated with a three-day gap between each repetition This schedule ensures that each group receives the intervention on separate days and allows for sufficient time between experiments to minimize any carryover effects or potential confounding factors Baseline fasting blood glucose levels will also be assessed before consuming the test foods
The primary outcomes of the study are the glycemic index GI and postprandial glycemia The glycemic index will be calculated through incremental area under the curve iAUC of the test food to that of standard food The iAUC values will be compared between the intervention groups to assess the effects of lysine and phosphorous fortification on glycemic response
The statistical analysis plan will include descriptive statistics to summarize participant characteristics and baseline variables Statistical tests such as analysis of variance ANOVA or non-parametric equivalent tests will be used to compare the intervention groups
The time frame for the study will focus on the immediate post-meal period typically within 2 hour to evaluate the acute effects of the bread interventions on blood glucose levels The study protocol takes into account ethical considerations participant recruitment informed consent data collection procedures and data analysis methods
The scientific background of the study includes a review of existing literature on the effects of lysine and phosphorous on glycemic response It provides a rationale for investigating the specific research question and highlights the potential implications of the study findings
Overall the study protocol outlines a rigorous and systematic approach to investigate the effect of lysine and phosphorous fortification on the glycemic index and postprandial glycemia of white bread The detailed description ensures clarity and transparency in the research methodology allowing researchers participants and data users to understand the objectives design methods and statistical considerations of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None