Effects of Raw Versus Other Milk Sources on Lactose Digestion

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

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.

Study Overview

• Status: Completed
• Conditions: Lactose Intolerance
• Intervention / Treatment: Behavioral: Raw Milk; Behavioral: Pasteurized Milk; Behavioral: Non-dairy milk

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stanford University

Publications and helpful links

General Publications

• 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.

Helpful Links

• Study description and summary of results

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: May 21, 2010
• First Submitted That Met QC Criteria: May 24, 2010
• First Posted (Estimate): May 25, 2010

Study Record Updates

• Last Update Posted (Estimate): February 22, 2023
• Last Update Submitted That Met QC Criteria: February 18, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Adults; Lactose intolerance; Dairy products; Raw milk
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Genetic Diseases, Inborn; Intestinal Diseases; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Malabsorption Syndromes; Lactose Intolerance
• Other Study ID Numbers: SU-05062010-5882

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No