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Effect of Lysine and Phosphorus Fortification on Glycemic Index and Postprandial Glycemia in Double Fortified Bread (LP-DFB-GI-PG)

Primary Purpose

Hyperglycemia, Glucose Metabolism Disorders, Metabolic Disease

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Control Group - Standard White Bread
Lysine Group - Lysine-Fortified Bread
Phosphorus Group - Phosphorus-Fortified Bread
Lysine and Phosphorus Group - Double Fortified Bread
Sponsored by
University of Veterinary and Animal Sciences, Lahore - Pakistan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperglycemia focused on measuring Glycemic Index, Postprandial Glycemia, Lysine, Phosphorus, White bread, Glycemic Control

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Subjects are appropriate if they are in the age range between 18 and 35 years. Subjects should be within normal range of BMI 18.5 to 24.5 kg per meter square. Efforts will be made to age and gender match subjects Exclusion Criteria: Subjects with diabetes, cardiovascular, cerebrovascular, pulmonary, hepatic, renal, endocrinological (PTH), or any significant medical disease will be excluded. Pregnant and lactating women. Subjects on regular use of any medication and supplements. Subjects that have any type of food allergy.

Sites / Locations

  • University of Veterinary and Animal SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Control Group - Standard White Bread

Lysine Group - Lysine-Fortified Bread

Phosphorus Group - Phosphorus-Fortified Bread

Lysine and Phosphorus Group - Double Fortified Bread

Arm Description

This arm serves as the control group in the clinical trial, providing a baseline comparison for the intervention arms. Participants in this arm consume standard white bread

This arm investigates the effect of lysine-fortified bread on glycemic response. Participants in this arm consume bread fortified with lysine, an essential amino acid.

This arm explores the impact of phosphorus-fortified bread on glycemic response. Participants in this arm consume bread fortified with phosphorus, an essential mineral.

This arm examines the combined effect of lysine and phosphorus in double fortified bread on glycemic response. Participants in this arm consume bread fortified with both lysine and phosphorus.

Outcomes

Primary Outcome Measures

Measure 1 - Postprandial Glycemia
Postprandial glycemia will be assessed at specific time intervals following the consumption of the test foods. The blood glucose levels will be measured using standardized methods, such as finger prick blood glucose testing using glucometer. The postprandial glycemia metric provides valuable information about the short-term effects of the different bread interventions on blood glucose regulation and response
Measure 2- Glycemic Index (GI) of the white bread
Glycemic Index is determined by measuring the rise in blood glucose levels over a specific time period after consuming a fixed amount of the test food, compared to a reference food (usually glucose or white bread). The GI value is expressed as a percentage or a numerical scale.

Secondary Outcome Measures

Full Information

First Posted
May 24, 2023
Last Updated
June 16, 2023
Sponsor
University of Veterinary and Animal Sciences, Lahore - Pakistan
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1. Study Identification

Unique Protocol Identification Number
NCT05903625
Brief Title
Effect of Lysine and Phosphorus Fortification on Glycemic Index and Postprandial Glycemia in Double Fortified Bread
Acronym
LP-DFB-GI-PG
Official Title
Effect of Lysine and Phosphorous in Double Fortified Bread on Glycemic Index (GI) of White Bread and Postprandial Glycemia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Veterinary and Animal Sciences, Lahore - Pakistan

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 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia, Glucose Metabolism Disorders, Metabolic Disease, Glycemic Index
Keywords
Glycemic Index, Postprandial Glycemia, Lysine, Phosphorus, White bread, Glycemic Control

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This clinical trial utilizes a cross-over design, administering multiple interventions to the same group of participants. The interventions include standard white bread, lysine-fortified bread, phosphorous-fortified bread, and a combination of lysine and phosphorous-fortified bread. Each participant receives these interventions in a specific sequence, with a washout period between each one to eliminate residual effects. This design allows for within-subject comparisons and minimizes individual variability. By examining the effects on glycemic index and postprandial glycemia, the cross-over design provides comprehensive insights. It enhances efficiency, statistical power, and enables the exploration of treatment interactions. Overall, this cross-over design allows for a thorough investigation of the impact of these interventions on glycemic index and postprandial glycemia in the study's participants.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group - Standard White Bread
Arm Type
Experimental
Arm Description
This arm serves as the control group in the clinical trial, providing a baseline comparison for the intervention arms. Participants in this arm consume standard white bread
Arm Title
Lysine Group - Lysine-Fortified Bread
Arm Type
Experimental
Arm Description
This arm investigates the effect of lysine-fortified bread on glycemic response. Participants in this arm consume bread fortified with lysine, an essential amino acid.
Arm Title
Phosphorus Group - Phosphorus-Fortified Bread
Arm Type
Experimental
Arm Description
This arm explores the impact of phosphorus-fortified bread on glycemic response. Participants in this arm consume bread fortified with phosphorus, an essential mineral.
Arm Title
Lysine and Phosphorus Group - Double Fortified Bread
Arm Type
Experimental
Arm Description
This arm examines the combined effect of lysine and phosphorus in double fortified bread on glycemic response. Participants in this arm consume bread fortified with both lysine and phosphorus.
Intervention Type
Dietary Supplement
Intervention Name(s)
Control Group - Standard White Bread
Intervention Description
Participants consume commercially available standard white bread, serving as the control intervention.
Intervention Type
Dietary Supplement
Intervention Name(s)
Lysine Group - Lysine-Fortified Bread
Intervention Description
Participants consume bread fortified with lysine, an essential amino acid, in a specified dosage, frequency, and duration.
Intervention Type
Dietary Supplement
Intervention Name(s)
Phosphorus Group - Phosphorus-Fortified Bread
Intervention Description
Participants consume bread fortified with phosphorus, an essential mineral, in a specified dosage, frequency, and duration
Intervention Type
Dietary Supplement
Intervention Name(s)
Lysine and Phosphorus Group - Double Fortified Bread
Intervention Description
Double Fortified Bread: Participants consume bread fortified with both lysine and phosphorus in specified dosages, frequencies, and durations.
Primary Outcome Measure Information:
Title
Measure 1 - Postprandial Glycemia
Description
Postprandial glycemia will be assessed at specific time intervals following the consumption of the test foods. The blood glucose levels will be measured using standardized methods, such as finger prick blood glucose testing using glucometer. The postprandial glycemia metric provides valuable information about the short-term effects of the different bread interventions on blood glucose regulation and response
Time Frame
120 minutes of post-meal consumption
Title
Measure 2- Glycemic Index (GI) of the white bread
Description
Glycemic Index is determined by measuring the rise in blood glucose levels over a specific time period after consuming a fixed amount of the test food, compared to a reference food (usually glucose or white bread). The GI value is expressed as a percentage or a numerical scale.
Time Frame
up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects are appropriate if they are in the age range between 18 and 35 years. Subjects should be within normal range of BMI 18.5 to 24.5 kg per meter square. Efforts will be made to age and gender match subjects Exclusion Criteria: Subjects with diabetes, cardiovascular, cerebrovascular, pulmonary, hepatic, renal, endocrinological (PTH), or any significant medical disease will be excluded. Pregnant and lactating women. Subjects on regular use of any medication and supplements. Subjects that have any type of food allergy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mah Noor, MPhil
Phone
923095702804
Email
dn.mahnoormatloob@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dr.Waqas Ahmed
Phone
923335950108
Email
waqas.niaz@uvas.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mah Noor, MPhil
Organizational Affiliation
University of Veterinary and Animal Sciences, Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Veterinary and Animal Sciences
City
Lahore
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mah Noor, Mphil
Phone
923095702804
Email
dn.mahnoormatloob@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27269925
Citation
Fang L, Li X. [Level of serum phosphorus and adult type 2 diabetes mellitus]. Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2016 May;41(5):502-6. doi: 10.11817/j.issn.1672-7347.2016.05.009. Chinese.
Results Reference
result
PubMed Identifier
36132073
Citation
Jozi F, Kheiripour N, Taheri MA, Ardjmand A, Ghavipanjeh G, Nasehi Z, Shahaboddin ME. L-Lysine Ameliorates Diabetic Nephropathy in Rats with Streptozotocin-Induced Diabetes Mellitus. Biomed Res Int. 2022 Sep 12;2022:4547312. doi: 10.1155/2022/4547312. eCollection 2022.
Results Reference
result
PubMed Identifier
30965074
Citation
Bahmani F, Bathaie SZ, Aldavood SJ, Ghahghaei A. Prevention of alpha-crystallin glycation and aggregation using l-lysine results in the inhibition of in vitro catalase heat-induced-aggregation and suppression of cataract formation in the diabetic rat. Int J Biol Macromol. 2019 Jul 1;132:1200-1207. doi: 10.1016/j.ijbiomac.2019.04.037. Epub 2019 Apr 6.
Results Reference
result
PubMed Identifier
26514124
Citation
Khattab M, Abi-Rashed C, Ghattas H, Hlais S, Obeid O. Phosphorus ingestion improves oral glucose tolerance of healthy male subjects: a crossover experiment. Nutr J. 2015 Oct 29;14:112. doi: 10.1186/s12937-015-0101-5.
Results Reference
result
PubMed Identifier
19553295
Citation
Kalogeropoulou D, LaFave L, Schweim K, Gannon MC, Nuttall FQ. Lysine ingestion markedly attenuates the glucose response to ingested glucose without a change in insulin response. Am J Clin Nutr. 2009 Aug;90(2):314-20. doi: 10.3945/ajcn.2008.27381. Epub 2009 Jun 24.
Results Reference
result
PubMed Identifier
25100072
Citation
Jordi J, Herzog B, Lutz TA, Verrey F. Novel antidiabetic nutrients identified by in vivo screening for gastric secretion and emptying regulation in rats. Am J Physiol Regul Integr Comp Physiol. 2014 Oct 1;307(7):R869-78. doi: 10.1152/ajpregu.00273.2014. Epub 2014 Aug 6.
Results Reference
result
Links:
URL
http://www.clinicaltrials.gov/ct2/show/NCT03836495
Description
This interventional clinical trial aims to assess the effects of fortifying white flour with lysine and/or phosphorus on postprandial glycemia and energy expenditure.

Learn more about this trial

Effect of Lysine and Phosphorus Fortification on Glycemic Index and Postprandial Glycemia in Double Fortified Bread

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