Effects of Raw Versus Other Milk Sources on Lactose Digestion

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Raw Milk Consumption vs. Other Milk Sources on Lactose Digestion in Healthy Individuals With Self-reported Lactose Intolerance

Conditions
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Lactose Intolerance

Intervention / Treatment
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* Behavioral: Raw Milk
* Behavioral: Pasteurized Milk
* Behavioral: Non-dairy milk


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Raw Milk first<br>Organic raw cow's milk | Behavioral: Raw Milk<br>* 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.<br>|
| Placebo Comparator: Pasteurized milk first<br>Organic pasteurized cow's milk | Behavioral: Pasteurized Milk<br>* 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.<br>|
| Placebo Comparator: Non-Dairy Milk first<br>Unflavored soy milk | Behavioral: Non-dairy milk<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Day 1 and day 8 of each milk phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 7 of each milk phase | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adults, Lactose intolerance, Dairy products, Raw milk