Effects of Raw Versus Other Milk Sources on Lactose Digestion

Not Applicable

Completed

• Conditions: Lactose Intolerance
• Interventions: Behavioral: Pasteurized Milk; Behavioral: Non-dairy milk; Behavioral: Raw Milk

• Registration Number: NCT01129791
• Lead Sponsor: Stanford University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-05-21
• Study First Submitted QC: 2010-05-24
• Study First Posted: 2010-05-25
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-18
• Last Update Posted: 2023-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pasteurized milk first	Pasteurized Milk	Organic pasteurized cow's milk
Non-Dairy Milk first	Non-dairy milk	Unflavored soy milk
Raw Milk first	Raw Milk	Organic raw cow's milk

Primary Outcome Measures

Name	Time	Method
Change in Area Under the Curve (AUC) of Hydrogen (H2) production from day 1 at day 8	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

Name	Time	Method
Severity of symptoms of lactose intolerance for each milk phase	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.

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States