Effects of Raw Versus Other Milk Sources on Lactose Digestion
|ClinicalTrials.gov Identifier: NCT01129791|
Recruitment Status : Completed
First Posted : May 25, 2010
Last Update Posted : June 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Lactose Intolerance||Behavioral: Raw Milk Behavioral: Pasteurized Milk Behavioral: Non-dairy milk||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Comparison of Raw Milk Consumption vs. Other Milk Sources on Lactose Digestion in Healthy Individuals With Self-reported Lactose Intolerance|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||September 2010|
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.
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01129791
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Christopher D Gardner||Stanford University|