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Comparing the Digestion of Milk With Different Beta-casein Protein Content by Dairy Intolerant Persons

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ClinicalTrials.gov Identifier: NCT03713346
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
Dennis A. Savaiano, Purdue University

Brief Summary:

Persons with dairy intolerance may experience cramps/abdominal pain, bloating, flatulence, acute diarrhea, or fecal urgency when they ingest excessive amounts of lactose. The intensity of these conditions can be mild or severe and likely depends on numerous variables including dose, transit time, intestinal residual lactase activity and microbiome potential to ferment lactose (Haverberg et al, 1980; Johnson et al, 1993; Newcomer et al, 1978; Rask Pedersen et al, 1982; Reasoner et al, 1981; Savaiano and Levitt; 1987; Scrimshaw and Murray, 1988; Suarez et al, 1995; Suarez et al, 1997; Briet et al, 1997; Hertzler and Savaiano, 1996; Savaiano et al, 2001; Dehkordi et al, 1995; Lee and Hardy; 1989; Leichter, 1973; Martini and Savaiano, 1988; Solomons et al, 1985; Welsh and Hall, 1977; Gilliland and Kim, 1984; Kolars et al, 1984; Lerebours et al, 1989; Savaiano et al, 1984; Shermak et al, 1995). Jersey cattle produce milk containing high levels of the A2 β-casein protein (Gustavsson, 2014). There are claims that high A2 β-casein milk is more easily digested by people who are lactose maldigesters (Ho, 2014). We propose to conduct a double-blinded, randomized, controlled trial to determine if high A2 β-casein milk from Jersey cattle is actually better digested and tolerated by lactose maldigesters.

This proposed protocol comparing the dairy intolerance symptoms from milks containing predominantly the A1 variant versus A2 variant will establish if high A2 milk is better digested and/or tolerated than high A1 milk.

Participants will be asked to consume four different commercially available milks in random order. The samples will be fed for breakfast separated by at least 10 days, after overnight fasts. The commercial milk treatments will include; high A1 β-casein milk (commercial milk), high A2 β-casein milk, Jersey cattle milk (which contains a mixture of A1 and A2 β-casein), and a lactose free milk control. Milk will be 2% fat content to control for transit. Each subject will be fed milk containing 0.5g lactose per kg body weight. There will be two arms in this study: dairy intolerant who are lactose maldigesters, and dairy intolerant who are lactose digesters.


Condition or disease Intervention/treatment Phase
Dairy Intolerance Other: Lactose free milk Other: Jersey milk Other: High A1 β-casein milk Other: High A2 β-casein milk Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: Comparing the Digestion of Milk With Different Beta-casein Protein Content by Dairy Intolerant Persons
Actual Study Start Date : January 17, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Casein

Arm Intervention/treatment
Lactose digester Other: Lactose free milk
Single dose of lactose free milk

Other: Jersey milk
Single dose of jersey milk

Other: High A1 β-casein milk
Single dose of high A1 β-casein milk (commercial milk)

Other: High A2 β-casein milk
Single dose of A2 β-casein milk

Lactose maldigester Other: Lactose free milk
Single dose of lactose free milk

Other: Jersey milk
Single dose of jersey milk

Other: High A1 β-casein milk
Single dose of high A1 β-casein milk (commercial milk)

Other: High A2 β-casein milk
Single dose of A2 β-casein milk




Primary Outcome Measures :
  1. Differences in AUC ΔH2 concentrations [ Time Frame: Within the 6 hours following the milk challenge ]
    Differences in AUC ΔH2 concentrations (primary outcomes) among milk phases is examined by repeated-measures analysis of variance (ANOVA)


Secondary Outcome Measures :
  1. Differences within each of the symptom categories [ Time Frame: Within the 6 hours following the milk challenge ]
    Repeated-measures ANOVA is also used to test for differences within each of the symptom categories (secondary outcomes) after transforming to correct for nonstationary variance. For both the H2 concentrations and symptom levels, to be able to detect differences between every single treatment, pairwise differences are examined using least significant difference (LSD).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion 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 and avoidance of milk 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 lactose intolerance (e.g., Lactaid® Dietary Supplements) during study involvement
  5. Willing to return for all study visits and complete all study related procedures, including fasting before and during the hydrogen breath tests
  6. Qualifying Lactose Challenge Symptom Score:

(4 symptom categories with severity measured on from 0 to 5) as defined by one of the following:

  1. At least one score of "moderately severe" or "severe" on a single symptom during the 6 hour HBT test;
  2. A score of "moderate" or greater for a single symptom on at least two (2) time points during the 6 hour HBT test;
  3. At least one "moderate" score or greater on each of two symptoms during the 6 hour HBT test 7. Hydrogen concentration of at least 20 parts per million greater than baseline at least 2 time points during the screening hydrogren breath test 8. Able to understand and provide written informed consent in English

Exclusion Criteria:

  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. BMI > 35 kg/m2
  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 lactose 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 symptoms of lactose intolerance (i.e., gas, diarrhea, bloating, cramps, stomach pain)
  19. History of ethanol (alcohol) and/or drug abuse in the past 12 months
  20. Currently undergoing chemotherapy
  21. Use of any investigational drug or participation in any investigational study within 30 days prior to screening
  22. Prior enrollment in this study
  23. Any other conditions/issues noted by the study staff and/or Principal Investigator that would impact participation and/or protocol compliance

    -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713346


Contacts
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Contact: Dennis Savaiano, PhD 765 427 7826 savaiano@purdue.edu
Contact: Tracy Eaton 765 494 6083 tkeaton@purdue.edu

Locations
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United States, Indiana
Purdue University Recruiting
West Lafayette, Indiana, United States, 47907-2059
Contact: Dennis Savaiano, PhD    765-427-7826    savaiano@purdue.edu   
Contact: Tracy Eaton, MSW    765 494 6083    tkeaton@purdue.edu   
Principal Investigator: Dennis Savaiano, PhD         
Sponsors and Collaborators
Purdue University

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Responsible Party: Dennis A. Savaiano, Virginia Claypool Meredith Professor of Nutrition Policy, Purdue University
ClinicalTrials.gov Identifier: NCT03713346     History of Changes
Other Study ID Numbers: 1710019781
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dennis A. Savaiano, Purdue University:
lactose intolerance, dairy intolerance

Additional relevant MeSH terms:
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Caseins
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action