Lactose Intolerance
Conditions
Keywords
Lactose intolerance, Dairy products, Raw milk, Adults
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.
Interventions
BEHAVIORALRaw 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.
BEHAVIORALPasteurized 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.
BEHAVIORALNon-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.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed