Effects of Raw Versus Other Milk Sources on Lactose Digestion

NCT ID: NCT01129791

Last Updated: 2023-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2010-09-30

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.

Conditions

Lactose Intolerance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Raw Milk first

Organic raw cow's milk

Group Type: EXPERIMENTAL

Raw Milk

Intervention Type: BEHAVIORAL

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 first

Organic pasteurized cow's milk

Group Type: PLACEBO_COMPARATOR

Pasteurized Milk

Intervention Type: BEHAVIORAL

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 first

Unflavored soy milk

Group Type: PLACEBO_COMPARATOR

Non-dairy milk

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Christopher Gardner

Professor of Medicine (Research)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher D Gardner

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 24615309 (View on PubMed)

Related Links

https://med.stanford.edu/nutrition/research/completed-studies/raw-milk-study.html

Study description and summary of results

Other Identifiers

SU-05062010-5882

Identifier Type: -

Identifier Source: org_study_id