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

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ClinicalTrials.gov Identifier: NCT05903625
Recruitment Status : Enrolling by invitation
First Posted : June 15, 2023
Last Update Posted : December 27, 2023
Sponsor:
Information provided by (Responsible Party):
Mahnoor, University of Veterinary and Animal Sciences, Lahore - Pakistan

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


Condition or disease Intervention/treatment Phase
Hyperglycemia Glucose Metabolism Disorders Metabolic Disease Glycemic Index Dietary Supplement: Control Group - Standard White Bread Dietary Supplement: Lysine Group - Lysine-Fortified Bread Dietary Supplement: Phosphorus Group - Phosphorus-Fortified Bread Dietary Supplement: Lysine and Phosphorus Group - Double Fortified Bread Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: Effect of Lysine and Phosphorous in Double Fortified Bread on Glycemic Index (GI) of White Bread and Postprandial Glycemia
Actual Study Start Date : November 13, 2023
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Glucose

Arm Intervention/treatment
Experimental: Control Group - Standard White Bread
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
Dietary Supplement: Control Group - Standard White Bread
Participants consume commercially available standard white bread, serving as the control intervention.

Experimental: Lysine Group - Lysine-Fortified 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.
Dietary Supplement: Lysine Group - Lysine-Fortified Bread
Participants consume bread fortified with lysine, an essential amino acid, in a specified dosage, frequency, and duration.

Experimental: Phosphorus Group - Phosphorus-Fortified Bread
This arm explores the impact of phosphorus-fortified bread on glycemic response. Participants in this arm consume bread fortified with phosphorus, an essential mineral.
Dietary Supplement: Phosphorus Group - Phosphorus-Fortified Bread
Participants consume bread fortified with phosphorus, an essential mineral, in a specified dosage, frequency, and duration

Experimental: Lysine and Phosphorus Group - Double Fortified Bread
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.
Dietary Supplement: Lysine and Phosphorus Group - Double Fortified Bread
Double Fortified Bread: Participants consume bread fortified with both lysine and phosphorus in specified dosages, frequencies, and durations.




Primary Outcome Measures :
  1. Measure 1 - Postprandial Glycemia [ Time Frame: 120 minutes of post-meal consumption ]
    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

  2. Measure 2- Glycemic Index (GI) of the white bread [ Time Frame: up to 12 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05903625


Locations
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Pakistan
University of Veterinary and Animal Sciences
Lahore, Pakistan
Sponsors and Collaborators
University of Veterinary and Animal Sciences, Lahore - Pakistan
Investigators
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Principal Investigator: Mah Noor, MPhil University of Veterinary and Animal Sciences, Lahore
Additional Information:
Publications of Results:

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Responsible Party: Mahnoor, MPhil Scholar, UVAS, University of Veterinary and Animal Sciences, Lahore - Pakistan
ClinicalTrials.gov Identifier: NCT05903625    
Other Study ID Numbers: Double Salt UVAS
First Posted: June 15, 2023    Key Record Dates
Last Update Posted: December 27, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mahnoor, University of Veterinary and Animal Sciences, Lahore - Pakistan:
Glycemic Index
Postprandial Glycemia
Lysine
Phosphorus
White bread
Glycemic Control
Additional relevant MeSH terms:
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Hyperglycemia
Metabolic Diseases
Glucose Metabolism Disorders