Effects of Raw Versus Other Milk Sources on Lactose Digestion

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01129791
First received: May 21, 2010
Last updated: June 21, 2011
Last verified: June 2011
  Purpose

The purpose of this small, short pilot study is to determine the feasibility (e.g., recruitment, dose acceptance, retention) of a future longer trial comparing the effects of different types of milk (raw milk, cow's milk, nondairy-milk) on lactose maldigestion.


Condition Intervention Phase
Lactose Intolerance
Behavioral: Raw Milk vs Pasteurized Cow's Milk vs Non-Dairy Milk
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison of Raw Milk Consumption vs. Other Milk Sources on Lactose Digestion in Healthy Individuals With Self-reported Lactose Intolerance

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Hydrogen Breath Test [ Time Frame: 1 week for each type of milk ] [ Designated as safety issue: No ]
  • Reported symptoms [ Time Frame: 1 week for each type of milk ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: February 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Raw Milk Behavioral: Raw Milk vs Pasteurized Cow's Milk vs Non-Dairy Milk
Participants underwent three 8-day milk phases (raw vs. two controls: pasteurized, soy) in randomized order separated by 1-week washout periods.
No Intervention: Pasteurized cow's milk Behavioral: Raw Milk vs Pasteurized Cow's Milk vs Non-Dairy Milk
Participants underwent three 8-day milk phases (raw vs. two controls: pasteurized, soy) in randomized order separated by 1-week washout periods.
No Intervention: Non-Dairy Milk Behavioral: Raw Milk vs Pasteurized Cow's Milk vs Non-Dairy Milk
Participants underwent three 8-day milk phases (raw vs. two controls: pasteurized, soy) in randomized order separated by 1-week washout periods.

Detailed Description:

The goal is to determine if raw milk consumption intake will benefit humans with lactose maldigestion, a common human response to the intake of dairy products during adult years. An increasing number of people are consuming raw unpasteurized milk. Enhanced nutritional qualities, taste, and health benefits have all been advocated as reasons for increased interest in raw milk consumption.

However, science-based data to substantiate these claims are limited or anecdotal.

Raw milk may differ in its ability to improve lactose maldigestion related symptoms from other milk types. Adult lactose maldigestion affects the majority of the world adult population. It appears that consumption of lactose containing foods by those who cannot digest lactose is a relatively common cause of irritable bowel syndrome.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Gender: Both women and men
  • Age: > or = 18 years
  • Ethnicity and race: All ethnic and racial backgrounds welcome
  • Elevation of breath hydrogen after ingestion of 25 g of lactose > 20 ppm over baseline
  • Planning to be available for clinic visits for the 6 weeks of study participation
  • Ability and willingness to give written informed consent
  • No known active psychiatric illness.

Exclusion Criteria:

  • Intake of antibiotics or other medications within the past month
  • History of diarrheal illness within past month
  • Secondary lactase deficiency
  • Self reported personal history of:

    *gastrointestinal conditions other than related with lactose maldigestion (IBS, IRB, Short bowel, malabsorption, celiac disease, GI surgery)

  • Pregnant or Lactating
  • Inability to communicate effectively with study personnel
  • Protein allergy related to cow 's milk proteins or soybean proteins
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01129791

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Christopher D Gardner Stanford University
  More Information

Additional Information:
No publications provided

Responsible Party: Christopher D Gardner, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT01129791     History of Changes
Other Study ID Numbers: SU-05062010-5882, 18384
Study First Received: May 21, 2010
Last Updated: June 21, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lactose Intolerance
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases

ClinicalTrials.gov processed this record on July 29, 2014