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Effects of Raw Versus Other Milk Sources on Lactose Digestion

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01129791
First Posted: May 25, 2010
Last Update Posted: June 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Christopher Gardner, Stanford University
  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
Lactose Intolerance Behavioral: Raw Milk Behavioral: Pasteurized Milk Behavioral: Non-dairy milk

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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 Christopher Gardner, Stanford University:

Primary Outcome Measures:
  • Change in Area Under the Curve (AUC) of Hydrogen (H2) production from day 1 at day 8 [ Time Frame: Day 1 and day 8 of each milk phase ]
    Calculated as the H2 AUC above baseline at day 8 minus the H2 AUC above baseline at day 1 of each milk phase


Secondary Outcome Measures:
  • Severity of symptoms of lactose intolerance for each milk phase [ Time Frame: Day 7 of each milk phase ]
    A validated gastrointestinal symptom log was used to mark on a 10-cm visual analog scale of 0 to 10 the severity of 4 symptoms: flatulence/gas, diarrhea, audible bowel sounds, and abdominal cramping.


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 first
Organic raw cow's milk
Behavioral: Raw Milk
Organic whole raw cow's milk, consumed daily in one sitting, at incremental doses from 4 to 24 oz. for 8 days. After a 1-week wash-out period, pasteurized cow's milk or non-dairy milk were consumed in the same fashion for another 8 days each.
Placebo Comparator: Pasteurized milk first
Organic pasteurized cow's milk
Behavioral: Pasteurized Milk
Organic whole pasteurized cow's milk, consumed daily in one sitting, at incremental doses from 4 to 24 oz. After a 1-week wash-out period, raw cow's milk or non-dairy milk were consumed in the same fashion for another 8 days each.
Placebo Comparator: Non-Dairy Milk first
Unflavored soy milk
Behavioral: Non-dairy milk
Unflavored soy milk, consumed daily in one sitting, at incremental doses from 4 to 24 oz. After a 1-week wash-out period, raw cow's milk or pasteurized cow's milk were consumed in the same fashion for another 8 days each.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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:
Publications:
Responsible Party: Christopher Gardner, Professor of Medicine (Research), Stanford University
ClinicalTrials.gov Identifier: NCT01129791     History of Changes
Other Study ID Numbers: SU-05062010-5882
First Submitted: May 21, 2010
First Posted: May 25, 2010
Last Update Posted: June 1, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Christopher Gardner, Stanford University:
Lactose intolerance
Dairy products
Raw milk
Adults

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