Barley Lysine Availability for Healthy Subjects

Overseen By Mahroukh Rafii, BSc.

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: The Hospital for Sick Children

Must not be taking: Steroids

Disqualifiers: Weight loss, Allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different cooking methods affect the availability of lysine, an essential amino acid, in barley. Lysine plays a crucial role in protein synthesis, which is vital for growth and bodily functions. The study focuses on healthy adult men without health issues affecting protein processing and who have maintained a stable weight recently. As an unphased trial, participants contribute to valuable nutritional research that may enhance dietary guidelines.

Will I have to stop taking my current medications?

The trial requires that you are not on any medications that could affect protein or amino acid metabolism, such as steroids. If your current medications do not affect these processes, you may not need to stop taking them.

What prior data suggests that barley is safe for consumption?

Research has shown that barley is generally safe to eat, though it is low in lysine, an essential protein building block. This deficiency means barley might not provide all necessary components for protein synthesis. Studies have explored adding lysine to barley to enhance its nutritional value, and no major safety concerns have emerged.

Barley contains beneficial plant compounds like phenolic acids and flavonoids, which might offer health benefits. No serious side effects are known from consuming barley itself. However, individuals with celiac disease or gluten sensitivity should avoid it because barley contains gluten.

Overall, most people tolerate barley well when included in a balanced diet. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring barley's lysine availability because it offers a natural and potentially beneficial way to enhance nutrition. Unlike supplements or fortified foods that add lysine artificially, barley provides this essential amino acid directly from a whole food source. This approach could lead to more sustainable and accessible dietary improvements, particularly for those seeking to boost their lysine intake naturally. By focusing on the metabolic availability of lysine from barley, researchers hope to uncover new insights into how we can optimize our diets for better health.

What evidence suggests that barley might be an effective treatment for improving lysine availability?

Research shows that barley is low in lysine, an important building block for proteins in the body. This means barley protein lacks quality because it doesn't have enough lysine to support effective protein synthesis. Studies also indicate that cooking methods can affect how much lysine the body can use from barley. While barley offers other health benefits due to its natural compounds, combining it with foods high in lysine can improve its protein quality. Understanding the lysine content in barley is crucial for enhancing its nutritional value.

The trial will investigate the metabolic availability of lysine in barley for healthy adult men. ^{1 4 5 6 7}

Who Is on the Research Team?

Glenda Courtney-Martin, PhD

Principal Investigator

Associate Scientist

Are You a Good Fit for This Trial?

This trial is for healthy young men aged 18-40 with stable body weight, not on medication affecting protein metabolism like steroids. They must have no clinical conditions such as diabetes that affect protein or amino acid metabolism and no recent significant weight changes.

Inclusion Criteria

I am healthy and do not have conditions like diabetes that affect protein metabolism.

I am not taking steroids or any drugs that affect protein in my body.

Stable Body Weight (±0 to 5lb weight gain or loss in the last 3 months)

Exclusion Criteria

You cannot eat the food provided in the study due to allergies or other reasons.

Recent history of weight loss within the last 3 months or on a weight reducing diet

I am not willing or able to follow the study's diet plan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Adaptation

Subjects are adapted to the level of lysine being studied, consuming the same diet as they will receive on the IAAO study day

2 days

No visits, meals consumed in usual environment

IAAO Study Day

Subjects undergo the oxidation study, consuming hourly meals and providing breath samples for analysis

1 day

1 visit (in-person, 5.5 hours)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Barley

Trial Overview

The study examines how the body uses lysine from barley, focusing on the impact of cooking methods on its availability. Barley's low lysine content affects protein synthesis, which is crucial for growth and bodily functions.

How Is the Trial Designed?

Group I: Meabolic Availabiliy of Barley Experimental Treatment 1 Intervention

Healthy adult men

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

A systematic review of 71 studies on L-lysine supplementation found that doses up to 6000 mg/day are generally safe, with the most common side effects being mild gastrointestinal issues like nausea and diarrhea.

The analysis showed no significant increase in the risk of gastrointestinal symptoms at higher doses, suggesting that L-lysine can be safely included in diets without major adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety assessment of L-lysine oral intake: a systematic review. Hayamizu, K., Oshima, I., Fukuda, Z., et al.[2019]

The increasing use of amino acids from various sources necessitates thorough safety assessments due to the potential for high intake levels that exceed normal dietary amounts.

Establishing reliable Tolerable Upper Intake Levels (ULs) for amino acids is challenging due to insufficient toxicity studies and lack of clinical data, highlighting the need for comprehensive safety evaluations that include quality specifications and potential interactions with medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Importance of Quality Specifications in Safety Assessments of Amino Acids: The Cases of l-Tryptophan and l-Citrulline. Oketch-Rabah, HA., Roe, AL., Gurley, BJ., et al.[2023]

Citations

1.

withpower.com

withpower.com/trial/phase-7-2022-41f87

Barley Lysine Availability for Healthy Subjects

The protein in barley is low in the essential amino acid lysine. Hence barley protein is of low quality. Low lysine affects protein synthesis in the body.

2.

ctv.veeva.com

ctv.veeva.com/study/metabolic-availability-of-lysine-from-barley-in-young-adult-men

Metabolic Availability of Lysine From Barley in Young Adult Men

The protein in barley is low in the essential amino acid lysine. Hence barley protein is of low quality. Low lysine affects protein synthesis ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666154323001849

Barley phytochemicals and health promoting benefits

This review investigates the phytochemicals found in barley, such as phenolic acid, flavonoids, lignans, tocols, phytosterols, and folates.

4.

gobarley.com

gobarley.com/wp-content/uploads/2018/03/EN-GoBarley-Healthy-Protein-Source.pdf

Barley—A Healthy Protein Source

Barley is deficient in lysine and low in either threonine or ... Health effects of protein intake in healthy adults: A systematic literature review.

5.

researchgate.net

researchgate.net/publication/344075426_Bioavailable_Lysine_Assessed_in_Healthy_Young_Men_Using_Indicator_Amino_Acid_Oxidation_is_Greater_when_Cooked_Millet_and_Stewed_Canadian_Lentils_are_Combined

Bioavailable Lysine, Assessed in Healthy Young Men ...

Results The BA of lysine was 97% from millet and 80% from lentils. Complementation of steamed millet with stewed lentils decreased the oxidation ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11976420/

L-lysine dietary supplementation for childhood and ...

This review aims to provide an overview of the overall effectiveness of lysine supplements concerning the growth of children and adolescents.

7.

mdpi.com

mdpi.com/2076-2615/9/2/33

The Effect of Barley and Lysine Supplementation ...

Supplementation with barley increased live weight gain, slaughter and carcass weights and fatness characteristics, whereas the addition of lysine to the barley- ...