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

University of Veterinary and Animal Sciences, Lahore - Pakistan

Status: Completed

Conditions: Glycemic Index; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Disease

Treatments: Dietary Supplement: Control Group - Standard White Bread; Dietary Supplement: Lysine and Phosphorus Group - Double Fortified Bread; Dietary Supplement: Phosphorus Group - Phosphorus-Fortified Bread; Dietary Supplement: Lysine Group - Lysine-Fortified Bread

Study type: Interventional

Funder types: Other

Identifiers

NCT05903625

Double Salt UVAS

Details and patient eligibility

About

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

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 4 patient groups

Control Group - Standard White Bread

Experimental group

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

Treatment:

Dietary Supplement: Control Group - Standard White Bread

Lysine Group - Lysine-Fortified Bread

Experimental group

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.

Treatment:

Dietary Supplement: Lysine Group - Lysine-Fortified Bread

Phosphorus Group - Phosphorus-Fortified Bread

Experimental group

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.

Treatment:

Dietary Supplement: Phosphorus Group - Phosphorus-Fortified Bread

Lysine and Phosphorus Group - Double Fortified Bread

Experimental group

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.

Treatment:

Dietary Supplement: Lysine and Phosphorus Group - Double Fortified Bread