Effects of Raw Versus Other Milk Sources on Lactose Digestion

Stanford University16 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Lactose Intolerance

Interventions

Raw MilkBEHAVIORAL

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 MilkBEHAVIORAL

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 milkBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Stanford University School of Medicine

Stanford, California, United States

Outcomes

Primary Outcomes

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

Time frame: Day 1 and day 8 of each milk phase

Secondary Outcomes

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.

Time frame: Day 7 of each milk phase

Data from ClinicalTrials.gov

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