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

Hyperglycemia Clinical Trial

— 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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05903625
• Other study ID #: Double Salt UVAS
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 13, 2023
• Est. completion date: January 2024

Study information

• Verified date: December 2023
• Source: University of Veterinary and Animal Sciences, Lahore - Pakistan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 15
• Est. completion date: January 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glucose Metabolism Disorders
• Glycemic Index
• Hyperglycemia
• Metabolic Disease
• Metabolic Diseases

Intervention

Dietary Supplement:
• Control Group - Standard White Bread
Participants consume commercially available standard white bread, serving as the control intervention.
• Lysine Group - Lysine-Fortified Bread
Participants consume bread fortified with lysine, an essential amino acid, in a specified dosage, frequency, and duration.
• Phosphorus Group - Phosphorus-Fortified Bread
Participants consume bread fortified with phosphorus, an essential mineral, in a specified dosage, frequency, and duration
• 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.

Locations

Country	Name	City	State
Pakistan	University of Veterinary and Animal Sciences	Lahore

Sponsors (1)

Lead Sponsor	Collaborator
University of Veterinary and Animal Sciences, Lahore - Pakistan

Country where clinical trial is conducted

Pakistan, 

References & Publications (6)

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 — View 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. — View 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. E — View 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. eCo — View 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 200 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	120 minutes of post-meal consumption
Primary	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.	up to 12 weeks

External Links

•   This interventional clinical trial aims to assess the effects of fortifying white flour with lysine and/or phosphorus on postprandial glycemia and energy expenditure.