Effects of Raw Versus Other Milk Sources on Lactose Digestion

Lactose Intolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01129791
• Other study ID #: SU-05062010-5882
• Status: Completed
• Phase: N/A
• Start date: February 2010
• Est. completion date: September 2010

Study information

• Verified date: February 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lactose Intolerance

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Study description and summary of results