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

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how individuals with a specific allergy react to different types of pork. The aim is to understand why some people with a gastrointestinal alpha-gal allergy (a meat allergy causing stomach pain, diarrhea, or nausea) experience symptoms after eating pork. Participants will consume ground pork containing alpha-gal and pork meat without alpha-gal to observe their body's response. Suitable candidates for this trial have experienced stomach issues related to eating meat and have improved after avoiding such foods. Participants should be willing to avoid certain medications before the trial and agree to the study conditions. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance the understanding and management of meat allergies.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that alpha-gal syndrome can cause allergic reactions to red meat, including pork. These reactions range from mild symptoms like itching and hives to severe reactions such as anaphylaxis, a serious allergic response. Studies have found that people with this syndrome might experience symptoms 3 to 8 hours after consuming meat containing alpha-gal.

However, pork without alpha-gal has been shown to be safer for people with this allergy. The FDA has confirmed that some specially bred pigs do not have detectable levels of alpha-gal, making their meat potentially safer for those with alpha-gal syndrome.

In summary, for individuals with alpha-gal syndrome, pork without alpha-gal may be a safer choice, while pork with alpha-gal might trigger allergic reactions. Always consult a healthcare professional before trying new foods if you have this allergy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a unique approach to managing Alpha-Gal Syndrome, a condition where people develop allergic reactions to red meat due to a specific sugar molecule called alpha-gal. Unlike the usual approach of avoiding red meat altogether, this trial involves consuming pork with and without alpha-gal to better understand the body's reaction. This method could pave the way for new strategies to manage or even desensitize patients to alpha-gal, potentially expanding dietary options for those affected by this condition.

What evidence suggests that this trial's treatments could be effective for alpha-gal syndrome?

Research has shown that alpha-gal syndrome is a meat allergy caused by a sugar found in some red meats, such as pork. People with this condition can experience reactions ranging from itching and hives to more severe symptoms after eating meat. In this trial, participants will undergo food challenges with two types of pork. One arm involves consuming pork with alpha-gal, which studies have found can trigger reactions because blood fat levels in affected individuals remain stable for hours after eating. The other arm involves consuming pork without alpha-gal, which might be safe for those with the syndrome. This type of pork is produced by removing the gene in pigs that produces alpha-gal, resulting in meat without this sugar. This suggests that alpha-gal-free pork could be a safer choice for people with this allergy. ^{3 5 6 7 8}

Who Is on the Research Team?

Sarah McGill, MD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

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.

The subject is willing to sign the informed consent form

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06268717

Study Details | NCT06268717 | GI Alpha-Gal Study 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 ...

2. ccjm.org ccjm.org/content/92/5/311

Recognizing and managing a tick-bite–related meat allergy Symptoms range from pruritus and hives to severe systemic reactions like anaphylaxis, and typically occur 3 to 8 hours after eating meat.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9484563/

The Meat of the Matter: Understanding and Managing Alpha ... After consuming pork, participants with alpha-gal syndrome had lipid blood levels that remained at baseline for several hours, compared to 2 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8592224/

Allergy to Mammalian Meat Linked to Alpha-Gal Syndrome ... This study is the first description of α-Gal syndrome due to mammalian meats in the Amazon region and the largest series ever reported in Latin America. With ...

5. consultqd.clevelandclinic.org consultqd.clevelandclinic.org/alpha-gal-syndrome-recognizing-and-managing-a-tick-biterelated-meat-allergy-part-i

Alpha-Gal Syndrome: Part I - Consult QD - Cleveland Clinic Identified in the early 2000s, alpha-gal syndrome is linked to meat sensitization from tick bites. Part I covers insights into the emerging ...

6. mayoclinic.org mayoclinic.org/diseases-conditions/alpha-gal-syndrome/symptoms-causes/syc-20428608

Alpha-gal syndrome - Symptoms and causes Alpha-gal syndrome causes mild to intense allergies to red meat, such as beef, pork or lamb. It also can cause reactions to other foods that ...

7. cdc.gov cdc.gov/alpha-gal-syndrome/data-research/products-containing-alpha-gal/index.html

Fast Facts: Products That May Contain Alpha-gal ... pork, or lamb, can contain high amounts of alpha-gal. These foods could trigger allergic reactions in people with alpha-gal syndrome (AGS).

8. mdpi.com mdpi.com/1422-0067/26/17/8601

Alpha-Gal Syndrome—A Series of Cases with Different ... Elevated alpha-gal-specific IgE levels were detected in five patients. Among them, four reported anaphylactic episodes following meat consumption. In three ...