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

October 7, 2021 updated by: Dennis A. Savaiano, Purdue University
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. Jersey cattle produce milk containing high levels of the A2 β-casein protein . There are claims that high A2 β-casein milk is more easily digested by people who are lactose maldigesters . 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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. Jersey cattle produce milk containing high levels of the A2 β-casein protein . There are claims that high A2 β-casein milk is more easily digested by people who are lactose maldigesters . 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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • West Lafayette, Indiana, United States, 47907-2059
        • Purdue University

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Within the 6 hours following the milk challenge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Within the 6 hours following the milk challenge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Purdue University

Investigators

  • Principal Investigator: Dennis A Savaiano, PhD, Purdue University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

January 17, 2018

Primary Completion (Actual)

September 3, 2021

Study Completion (Actual)

September 3, 2021

Study Registration Dates

First Submitted

April 4, 2018

First Submitted That Met QC Criteria

October 17, 2018

First Posted (Actual)

October 19, 2018

Study Record Updates

Last Update Posted (Actual)

October 8, 2021

Last Update Submitted That Met QC Criteria

October 7, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1710019781

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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