NCT01129791

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 25, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

February 22, 2023

Status Verified

February 1, 2023

Enrollment Period

7 months

First QC Date

May 21, 2010

Last Update Submit

February 18, 2023

Conditions

Lactose Intolerance

Keywords

Lactose intoleranceDairy productsRaw milkAdults

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Severity of symptoms of lactose intolerance for each milk phase

    Day 7 of each milk phase

Study Arms (3)

Raw Milk first

EXPERIMENTAL

Organic raw cow's milk

Behavioral: Raw Milk

Pasteurized milk first

PLACEBO COMPARATOR

Organic pasteurized cow's milk

Behavioral: Pasteurized Milk

Non-Dairy Milk first

PLACEBO COMPARATOR

Unflavored soy milk

Behavioral: Non-dairy milk

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.

Raw Milk first
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.

Pasteurized milk first
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.

Non-Dairy Milk first

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related 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.

    PMID: 24615309RESULT

Related Links

MeSH Terms

Conditions

Lactose Intolerance

Interventions

Milk

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesCarbohydrate Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Officials

  • Christopher D Gardner

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine (Research)

Study Record Dates

First Submitted

May 21, 2010

First Posted

May 25, 2010

Study Start

February 1, 2010

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

February 22, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)