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

NCT03713346 | Completed

• 1 other identifier: 1710019781
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Dairy Intolerance

Keywords

lactose; dairy; intolerance

Outcome Measures

Primary Outcomes (1)

• Differences in AUC ΔH2 concentrations

  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 Outcomes (1)

• Differences within each of the symptom categories

  Within the 6 hours following the milk challenge

Study Arms (2)

Lactose digester

OTHER

Other: Lactose free milk; Other: Jersey milk; Other: High A1 β-casein milk; Other: High A2 β-casein milk

Lactose maldigester

OTHER

Other: Lactose free milk; Other: Jersey milk; Other: High A1 β-casein milk; Other: High A2 β-casein milk

Interventions

Lactose free milk OTHER

Single dose of lactose free milk

Lactose digester; Lactose maldigester

Jersey milk OTHER

Single dose of jersey milk

Lactose digester; Lactose maldigester

High A1 β-casein milk OTHER

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

Lactose digester; Lactose maldigester

High A2 β-casein milk OTHER

Single dose of A2 β-casein milk

Lactose digester; Lactose maldigester

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability/desire to provide informed consent
• Aged 18 to 65 years of age inclusive at screening
• Current or recent history of intolerance to and avoidance of milk of at least one month duration (by self-report and self-reported symptoms).
• Agrees to refrain from all other treatments and products used for lactose intolerance (e.g., Lactaid® Dietary Supplements) during study involvement
• Willing to return for all study visits and complete all study related procedures, including fasting before and during the hydrogen breath tests
• Qualifying Lactose Challenge Symptom Score:
• (4 symptom categories with severity measured on from 0 to 5) as defined by one of the following:
• At least one score of "moderately severe" or "severe" on a single symptom during the 6 hour HBT test;
• A score of "moderate" or greater for a single symptom on at least two (2) time points during the 6 hour HBT test;
• 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

You may not qualify if:

• Allergic to milk
• Currently pregnant
• Currently lactating
• Cigarette smoking or other use of tobacco or nicotine containing products within 3 months of screening
• 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
• 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 \[Note: history of uncomplicated abdominal surgeries such as removal of an appendix more than 12 months prior to screening will not be excluded\]
• 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.
• Active ulcers, or history of severe ulcers
• Diabetes mellitus (type 1 and type 2)
• Congestive Heart Failure (CHF)
• Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C
• BMI \> 35 kg/m2
• Recent bowel preparation for endoscopic or radiologic investigation within four weeks of screening (e.g., colonoscopy prep)
• 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
• Chronic antacid and/or PPI use

Sponsors & Collaborators

• Purdue University: lead

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907-2059, United States

Location

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Study Officials

• Dennis A Savaiano, PhD

  Purdue University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Virginia Claypool Meredith Professor of Nutrition Policy

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: October 19, 2018
• Study Start: January 17, 2018
• Primary Completion: September 3, 2021
• Study Completion: September 3, 2021
• Last Updated: October 8, 2021

Record last verified: 2021-10

Locations

US (1)