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

7 Participants Needed

Trial Summary

What is the purpose of this trial?

Protein is the key determinant of growth and bodily functions. The quality of food proteins depend on their amino acid content and the amount of amino acids used by the body to make proteins. Globally Cereal Grains (CG) provide 50% of the calories and protein in the diet and exceed 80% in poorer developing countries. Barley is an important cereal grain in the diet. 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. Cooking methods also affect the lysine available from foods to the body. It is important to assess the effect of different cooking methods on the lysine availability of barley.

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.

Is L-lysine safe for human consumption?

L-lysine, when added to a regular diet, is generally safe for humans. Some people may experience mild stomach issues like nausea or diarrhea, but these are not common. The safe intake level is considered to be up to 6000 mg per day without significant risk of side effects. ^{1 2 3 4 5}

How does high-lysine barley differ from other treatments for improving protein quality?

High-lysine barley is unique because it has been genetically modified to increase its lysine content, an essential amino acid that is often limited in regular barley. This makes it superior in nutritional quality compared to normal barley, as it provides better protein quality and digestibility, which is beneficial for meeting dietary amino acid requirements. ^{4 6 7 8 9}

Research Team

Glenda Courtney-Martin, PhD

Principal Investigator

Associate Scientist

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Austria pubmed.ncbi.nlm.nih.gov

Safety assessment of L-lysine oral intake: a systematic review. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

The Importance of Quality Specifications in Safety Assessments of Amino Acids: The Cases of l-Tryptophan and l-Citrulline. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Analysis for availability of amino acid supplements in foods and feeds: biochemical and nutritional implications. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Protein quality and digestibility of new high-lysine barley varieties in growing rats. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Improvement in the nutritional quality of bread. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Protein quality of induced high lysine mutants in barley. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Variation of the amino acid scores and of the nitrogen-to-protein conversion factors in barley grain as a function of nitrogen content as compared with wheat and rye. [2019]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Amino acid composition and biological evaluation of the protein quality of high lysine barley genotypes. [2019]

9. England pubmed.ncbi.nlm.nih.gov

[Effect of amino acid supplements to barley meal on the nitrogen metabolism of growing castrated male swine (20-65 kg live weight)]. [2019]