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

NCT05903625 | Completed

• 1 other identifier: Double Salt UVAS
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Conditions

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Disease; Glycemic Index

Keywords

Glycemic Index; Postprandial Glycemia; Lysine; Phosphorus; White bread; Glycemic Control

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (4)

Control Group - Standard White Bread

EXPERIMENTAL

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

Lysine Group - Lysine-Fortified Bread

EXPERIMENTAL

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

Phosphorus Group - Phosphorus-Fortified Bread

EXPERIMENTAL

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

Lysine and Phosphorus Group - Double Fortified Bread

EXPERIMENTAL

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

Interventions

Control Group - Standard White Bread DIETARY_SUPPLEMENT

Participants consume commercially available standard white bread, serving as the control intervention.

Control Group - Standard White Bread

Lysine Group - Lysine-Fortified Bread DIETARY_SUPPLEMENT

Participants consume bread fortified with lysine, an essential amino acid, in a specified dosage, frequency, and duration.

Lysine Group - Lysine-Fortified Bread

Phosphorus Group - Phosphorus-Fortified Bread DIETARY_SUPPLEMENT

Participants consume bread fortified with phosphorus, an essential mineral, in a specified dosage, frequency, and duration

Phosphorus Group - Phosphorus-Fortified Bread

Lysine and Phosphorus Group - Double Fortified Bread DIETARY_SUPPLEMENT

Double Fortified Bread: Participants consume bread fortified with both lysine and phosphorus in specified dosages, frequencies, and durations.

Lysine and Phosphorus Group - Double Fortified Bread

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Veterinary and Animal Sciences, Lahore - Pakistan: lead

Study Sites (1)

University of Veterinary and Animal Sciences

Lahore, Pakistan

Location

Related Publications (6)

• 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.

  PMID: 27269925 BACKGROUND

• 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.

  PMID: 36132073 BACKGROUND

• 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.

  PMID: 30965074 BACKGROUND

• 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.

  PMID: 26514124 BACKGROUND

• 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.

  PMID: 19553295 BACKGROUND

• 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.

  PMID: 25100072 BACKGROUND

Related 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.

MeSH Terms

Conditions

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases

Interventions

Lysine

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Study Officials

• Mah Noor, MPhil

  University of Veterinary and Animal Sciences, Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MPhil Scholar, UVAS

Model Details: 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.

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 15, 2023
• Study Start: November 13, 2023
• Primary Completion: December 30, 2023
• Study Completion: January 31, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)