The Effect of Bread Fortification With Phosphorus and Lysine on Postprandial Glycaemia and Thermogenesis

NCT03836495 | Completed

• 1 other identifier: BIO-2017-0278
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Wheat and wheat derived products are highly consumed around the world. They constitute the major dietary source of protein and energy for many individuals. Wheat contains moderate quantity of low quality protein lacking in some essential amino acids, primarily lysine, thus wheat based diets can't sustain optimal growth, and accordingly should be supplemented with lysine or complemented by another protein source of better quality to match human needs. However, human studies showed that wheat flour fortification with lysine was able to slightly improve growth, namely by increasing weight gain, but it did not however completely reverse growth impairment provoked by the consumption of wheat-based diets. The investigators developed interest in the role of phosphorus in health and diseased and believe that the modest impact of lysine fortification may due to low phosphorus availability of wheat products. Phosphorus content of cereals is mainly in the form of phytate that is not bioavailable. Supplementing a wheat gluten based diet with a combination of lysine and phosphorus was able to highly amplify the increase in weight gain and energy efficiency of rats as compared to lysine or phosphorus supplementation alone. Phosphorus is an essential mineral known to be directly involved in the production of ATP, which is essential for many metabolic processes including protein synthesis. The investigators believe that a better approach to enhance the quality of a wheat-based diet is through the supplementation with a combination of both lysine and phosphorus. The present study is designed to investigate the effect of white flour fortification with lysine and/or phosphorus on sensory properties, postprandial glycaemia and insulinemia, as well as postprandial thermogenesis. Most specifically, we aim to:

1. 1.Determine the acceptability and assess sensory differences of the fortified breads.
2. 2.Determine the glycemic response after ingestion of the different fortified breads.
3. 3.Evaluate the variation in energy expenditure after the consumption of the fortified breads.

Conditions

Postprandial Hyperglycemia; Energy Expenditure

Outcome Measures

Primary Outcomes (2)

• Postprandial glycemia

  postprandial blood glucose level

  120 min

• Energy expenditure

  Postprandial energy expenditure

  240 min

Study Arms (4)

White bread unfortified (WB)

EXPERIMENTAL

bread with no lysine no phosphorus

Dietary Supplement: lysine and phosphorus

White bread fortified with lysine (WB-L)

EXPERIMENTAL

Bread with lysine

Dietary Supplement: lysine and phosphorus

White bread fortified with phosphorus (WB-P)

EXPERIMENTAL

bread with phosphorus

Dietary Supplement: lysine and phosphorus

White bread fortified with lysine and phosphorus (WB-LP)

EXPERIMENTAL

Bread with phosphorus and lysine

Dietary Supplement: lysine and phosphorus

Interventions

lysine and phosphorus DIETARY_SUPPLEMENT

addition of lysine and essential amino acid and/or phosphorus an essential mineral

White bread fortified with lysine (WB-L); White bread fortified with lysine and phosphorus (WB-LP); White bread fortified with phosphorus (WB-P); White bread unfortified (WB)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Efforts will be made to age and gender match subjects (balanced number of males and females in each group). Subjects are appropriate if they are in the age range between 18 and 60. Women who are in the reproductive age will be studied at the first half of their menstrual cycle, because estrogen is known to affect the energy expenditure. Postmenopausal women taking hormonal replacement therapy will be excluded. Subjects should have: Cr \<1mg/dl for women and \<1.2mg/dl for men and GFR \>60 ml/min/1.73m2.

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 medication that affects body weight and/or having a weight loss of 3% or more in the preceding 3 months.
• Subjects with: Cr \>1mg/dl for women and \>1.2mg/dl for men and GFR\<60 ml/min/1.73m2.

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut

Beirut, Lebanon

Location

MeSH Terms

Conditions

Hyperglycemia

Interventions

Lysine; Phosphorus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential; Elements; Inorganic Chemicals

Study Officials

• Omar Obeid, PhD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: February 11, 2019
• Study Start: February 6, 2019
• Primary Completion: May 10, 2020
• Study Completion: May 20, 2020
• Last Updated: October 6, 2025

Record last verified: 2019-02

Locations

LE (1)