Back to resultsEffects of Raw Versus Other Milk Sources on Lactose Digestion
Primary Purpose
Lactose Intolerance
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Raw Milk
Pasteurized Milk
Non-dairy milk
Sponsored by
About this trial
This is an interventional prevention trial for Lactose Intolerance focused on measuring Lactose intolerance, Dairy products, Raw milk, Adults
Eligibility 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
Sites / Locations
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
Raw Milk first
Pasteurized milk first
Non-Dairy Milk first
Arm Description
Organic raw cow's milk
Organic pasteurized cow's milk
Unflavored soy milk
Outcomes
Primary Outcome Measures
Change in Area Under the Curve (AUC) of Hydrogen (H2) production from day 1 at day 8
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01129791
Brief Title
Effects of Raw Versus Other Milk Sources on Lactose Digestion
Official Title
Comparison of Raw Milk Consumption vs. Other Milk Sources on Lactose Digestion in Healthy Individuals With Self-reported Lactose Intolerance
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lactose Intolerance
Keywords
Lactose intolerance, Dairy products, Raw milk, Adults
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Raw Milk first
Arm Type
Experimental
Arm Description
Organic raw cow's milk
Arm Title
Pasteurized milk first
Arm Type
Placebo Comparator
Arm Description
Organic pasteurized cow's milk
Arm Title
Non-Dairy Milk first
Arm Type
Placebo Comparator
Arm Description
Unflavored soy milk
Intervention Type
Behavioral
Intervention Name(s)
Raw Milk
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Pasteurized Milk
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Non-dairy milk
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Area Under the Curve (AUC) of Hydrogen (H2) production from day 1 at day 8
Description
Calculated as the H2 AUC above baseline at day 8 minus the H2 AUC above baseline at day 1 of each milk phase
Time Frame
Day 1 and day 8 of each milk phase
Secondary Outcome Measure Information:
Title
Severity of symptoms of lactose intolerance for each milk phase
Description
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.
Time Frame
Day 7 of each milk phase
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher D Gardner
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24615309
Citation
Mummah S, Oelrich B, Hope J, Vu Q, Gardner CD. Effect of raw milk on lactose intolerance: a randomized controlled pilot study. Ann Fam Med. 2014 Mar-Apr;12(2):134-41. doi: 10.1370/afm.1618.
Results Reference
result
Links:
URL
https://med.stanford.edu/nutrition/research/completed-studies/raw-milk-study.html
Description
Study description and summary of results
Learn more about this trial
Effects of Raw Versus Other Milk Sources on Lactose Digestion
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