Pork with Alpha-Gal for Alpha-Gal Syndrome

Overseen By Shilpa Karanjit, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: Omalizumab, Systemic steroids, NSAIDs, others

Disqualifiers: Cardiac disease, Pregnancy, Chronic GI conditions, others

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

Compensation: Varies

Number of Visits: 2

24 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

You will need to stop taking nonsteroidal anti-inflammatory medications, leukotriene modifiers, and steroids 14 days before the challenge. If you are using systemic steroids, you must stop 28 days before the food challenge. The protocol does not specify other medications, so please consult with the study team for more details.

What makes the treatment with pork containing alpha-gal unique for Alpha-Gal Syndrome?

This treatment is unique because it involves using pork meat that either contains or does not contain alpha-gal, a sugar molecule that triggers allergic reactions in people with Alpha-Gal Syndrome, offering a novel dietary approach to manage the condition. ^{1 2 3 4 5}

What is the purpose of this trial?

This is a double-blind, crossover food challenge study using pork with and without α-gal in patients with a clinical diagnosis of gastrointestinal (GI)- α-gal allergy, and to investigate the pathophysiology underlying their symptoms.

Research Team

Sarah McGill, MD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

This trial is for individuals with a clinical diagnosis of GI-alpha-gal allergy, which can cause symptoms like diarrhea, irritable bowel syndrome, abdominal pain, and vomiting. Specific eligibility criteria are not provided.

Inclusion Criteria

I feel better after not eating mammalian meat for a month.

I have had symptoms like stomach pain, diarrhea, or nausea due to an alpha-gal allergy.

The subject is willing to sign the informed consent form

Exclusion Criteria

The subject is allergic to mannitol

I've had diarrhea, severe stomach pain, or vomiting in the last 10 days.

The subject has a history of severe allergic reaction on mammalian meat ingestion (respiratory distress, chest pain or cardiopulmonary compromise)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Food Challenge Phase 1

Participants undergo a double-blind food challenge with pork meat containing alpha-gal sugar

1 day

1 visit (in-person)

Washout Period

A washout period of at least 10 days between food challenges

10 days

Food Challenge Phase 2

Participants undergo a double-blind food challenge with pork meat without alpha-gal sugar

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the food challenges

2-4 weeks

Treatment Details

Interventions

• Ground pork containing alpha-gal
• Pork meat not containing alpha-gal

Trial Overview The study tests the reaction to two types of pork: one containing alpha-gal and one without it. It's designed as a double-blind crossover challenge to understand how these foods affect patients with GI-alpha-gal allergy.

Participant Groups

Group I: Food challenge with pork meat containing alpha-gal, then pork meat without alpha gal sugar Active Control 2 Interventions

Participants receive a food challenge, consuming pork meat that contains alpha-gal. After a \>10-day washout period, participants undergo a food challenge with pork which does not contain alpha-gal.

Group II: Food challenge with pork meat without alpha gal sugar, then pork meat containing alpha-gal Active Control 2 Interventions

Participants receive a food challenge consuming pork meat that does not contain alpha-gal sugar. After a \>10-day washout period, participants undergo a food challenge with pork which does contain alpha-gal.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Revivicor, Inc

Collaborator

Trials

1

Recruited

20+

Findings from Research

In a study involving 72 pigs, dietary supplementation with conjugated linoleic acid (CLA) did not affect growth or carcass characteristics but significantly altered meat quality by reducing muscle pH and increasing yellowness, indicating potential changes in meat appearance.

Lysine supplementation increased muscle pH and collagen synthesis, suggesting it may enhance meat quality, while CLA reduced collagen synthesis and affected bone development, highlighting the complex interactions between diet and muscle characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influences of dietary conjugated linoleic acid (CLA) and total lysine content on growth, carcass characteristics and meat quality of heavy pigs. Corino, C., Musella, M., Pastorelli, G., et al.[2011]

A test diet for pigs, which was higher in α-linolenic acid (n-3 PUFA) and lower in linoleic acid (n-6 PUFA), led to significant increases in beneficial long-chain omega-3 fatty acids (EPA and DHA) in both muscle and adipose tissue, enhancing the nutritional value of pigmeat.

The modified diet improved the ratio of polyunsaturated to saturated fatty acids in pig muscle and reduced the n-6 to n-3 ratio, suggesting that pigmeat could be a valuable source of omega-3 fatty acids in the human diet, potentially providing 12 grams of long-chain n-3 PUFA annually per person in the UK.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feeding linseed to increase the n-3 PUFA of pork: fatty acid composition of muscle, adipose tissue, liver and sausages. Enser, M., Richardson, RI., Wood, JD., et al.[2019]

The study evaluated the shelf life of prepackaged retail-ready slices of Korean native black pig (KNP) belly and shoulder butt, finding that the shoulder butt reached unacceptable quality after 12 days, while the belly remained acceptable for up to 15 days.

KNP belly slices demonstrated a longer shelf life than shoulder butt slices, with recommended shelf lives of 12 days for belly and 9 days for shoulder butt based on sensory quality and chemical indicators of freshness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A study on shelf life of prepackaged retail-ready Korean native black pork belly and shoulder butt slices during refrigerated display. Hoa, VB., Seol, KH., Kang, SM., et al.[2021]

Using rosemary combined with smoking was the most effective method to mask the undesirable boar taint in chorizo made from entire male pigs with high androstenone levels, resulting in only a 3.7% selection rate for animal flavor.

Consumers preferred the sensory properties of chorizo made with high androstenone levels when rosemary was included, suggesting that this combination could lead to a more acceptable product in the market.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of masking strategies to avoid the boar taint perception in chorizo: consumers' acceptability. Peñaranda, I., Garrido, MD., Moumeh, B., et al.[2021]

In untreated fresh pork sausage stored at 4°C, microbial populations increased significantly, reaching nearly 10^8 CFU/g by day 30, indicating a rapid growth of potentially harmful bacteria.

The use of an antimicrobial combination of sodium lactate and sodium diacetate dramatically changed the microbial dynamics, leading to the dominance of Lactobacillus graminis and reducing the overall microbial diversity, which may enhance the safety and shelf-life of the product.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microbial successions are associated with changes in chemical profiles of a model refrigerated fresh pork sausage during an 80-day shelf life study. Benson, AK., David, JR., Gilbreth, SE., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Influences of dietary conjugated linoleic acid (CLA) and total lysine content on growth, carcass characteristics and meat quality of heavy pigs. [2011]

2. England pubmed.ncbi.nlm.nih.gov

Feeding linseed to increase the n-3 PUFA of pork: fatty acid composition of muscle, adipose tissue, liver and sausages. [2019]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

A study on shelf life of prepackaged retail-ready Korean native black pork belly and shoulder butt slices during refrigerated display. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Use of masking strategies to avoid the boar taint perception in chorizo: consumers' acceptability. [2021]

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

Microbial successions are associated with changes in chemical profiles of a model refrigerated fresh pork sausage during an 80-day shelf life study. [2021]