RECRUITING

Comparing the Inflammation, Maldigestion and Symptoms Due to Commercial Milk and A2 Milk

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Conditions

Lactose Intolerance

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Cow's milk contains two types of β-casein: A1 and A2. It is evident from human clinical trials that milk with A1 protein produces more hydrogen and symptoms of lactose intolerance. A pro-inflammatory μ-opioid peptide BCM-7 is released from A1 but not from A2. Milk containing A1 β-casein produced more inflammatory markers than A2 β-casein. This is a double-blinded, randomized, controlled trial conducted to determine if A1 beta-casein containing milk causes acute effects on inflammatory markers following a single milk feeding, as compared to milk containing only A2 beta-casein.

Official Title

Comparing the Acute Effects of A1 Containing Commercial Milk and A2 Milk on Inflammation, Lactose Intolerance and Lactose Maldigestion in Lactose Maldigesters

Quick Facts

Study Start:2022-01-18
Study Completion:2025-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05660278

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * • Ability/desire to provide informed consent
  2. * Aged 18 to 65 years of age inclusive at screening
  3. * Current or recent history of intolerance to or avoidance of dairy of at least one month duration (by self-report and self-reported symptoms).
  4. * Agrees to refrain from all other treatments and products used for dairy intolerance (e.g., Lactaid® Dietary Supplements) during study involvement
  5. * Willing to return for all study visits and complete all study related procedures
  6. * Able to understand and provide written informed consent in English
  1. * • Allergic to milk
  2. * Currently pregnant
  3. * Currently lactating
  4. * Cigarette smoking or other use of tobacco or nicotine containing products within 3 months of screening
  5. * Diagnosed with any of the following disorders known to be associated with abnormal gastrointestinal motility such as; Gastroparesis, amyloidosis, neuromuscular diseases (including Parkinson's disease), collagen vascular diseases, alcoholism, uremia, malnutrition, or untreated hypothyroidism
  6. * History of surgery that alters the normal function of the gastrointestinal tract including, but not limited to: gastrointestinal bypass surgery, bariatric surgery, gastric banding, vagotomy, fundoplication, pyloroplasty \[Note: history of uncomplicated abdominal surgeries such as removal of an appendix more than 12 months prior to screening will not be excluded\]
  7. * Past or present : Organ transplant, chronic pancreatitis, pancreatic insufficiency, symptomatic biliary disease, Celiac disease, chronic constipation, diverticulosis, inflammatory bowel disease (IBD), ulcerative colitis (UC), Crohn's disease (CD), small intestine bacterial overgrowth syndrome (SIBO), gastroparesis, gastro-esophageal reflux disease (GERD), Irritable Bowel Syndrome (IBS) or any other medical condition with symptoms that could confound collection of adverse events.
  8. * Active ulcers, or history of severe ulcers
  9. * Diabetes mellitus (type 1 and type 2)
  10. * Congestive Heart Failure (CHF)
  11. * Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C
  12. * Height: ___ Weight: ___ BMI: ___
  13. * Recent bowel preparation for endoscopic or radiologic investigation within four weeks of screening (e.g., colonoscopy prep)
  14. * Use of concurrent therapy(ies) or other products (e.g., laxatives, stool softeners, Pepto Bismol®, Lactaid® Dietary Supplements) used for symptoms of dairy intolerance within 7 days of screening
  15. * Chronic antacid and/or PPI use
  16. * Recent use of systemic antibiotics defined as use within 30 days prior to screening
  17. * Recent high colonic enema, defined as use within 30 days prior to screening
  18. * Any concurrent disease or symptoms which may interfere with the assessment of the cardinal
  19. * symptoms of dairy intolerance (i.e., gas, diarrhea, bloating, cramps, stomach pain)
  20. * History of ethanol (alcohol) and/or drug abuse in the past 12 months
  21. * Currently undergoing chemotherapy
  22. * Use of any investigational drug or participation in any investigational study within 30 days prior to screening
  23. * Prior enrollment in this study
  24. * Any other conditions/issues noted by the study staff and/or Principal Investigator that would impact participation and/or protocol compliance

Contacts and Locations

Study Contact

Dennis Savaiano, PhD
CONTACT
494-8228
savaiano@purdue.edu
Tracy Eaton, MSW
CONTACT
tkeaton@purdue.edu

Principal Investigator

Dennis Savaiano, PhD
PRINCIPAL_INVESTIGATOR
Purdue University

Study Locations (Sites)

Purdue University
West Lafayette, Indiana, 47906
United States

Collaborators and Investigators

Sponsor: Purdue University

  • Dennis Savaiano, PhD, PRINCIPAL_INVESTIGATOR, Purdue University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-18
Study Completion Date2025-08

Study Record Updates

Study Start Date2022-01-18
Study Completion Date2025-08

Terms related to this study

Additional Relevant MeSH Terms

  • Lactose Intolerance