Lactose IntoleranceNCT01331265
Perceived Lactose Intolerance
An observational study of Lactose Intolerance, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The goal of this study was to examine the effects of self-perceived lactose intolerance (SPLI) as it relates to calcium intake and specific health problems that have been attributed to reduced intake of calcium and foods from the dairy group in a nationally representative multi-ethnic sample of adults. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Lactose Intolerance
- How many people
- 3,815 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: white, black, and Hispanic adults; 18-50 years of age
Who may be able to join
- adults between 18 and 50 years old
Who cannot join
- pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Understanding Perceived Lactose Intolerance in White, Black, and Hispanic Adults
The goal of this study was to examine the effects of self-perceived lactose intolerance (SPLI) as it relates to calcium intake and specific health problems that have been attributed to reduced intake of calcium and foods from the dairy group in a nationally representative multi-ethnic sample of adults.
- Conditions
- Lactose Intolerance
- Keywords
- perceived lactose intolerance, calcium/dairy consumption, specific health outcomes
- Medical subject headings
- Lactose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| no treatment | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2011 (estimated)
- Study startJan 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lactose IntoleranceStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 3,815 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Responsible party
- Principal investigator, Theresa A Nicklas, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01331265
- Sponsor's protocol ID
- H-22651
- Status last verified
- Jan 2020
- First submitted
- 6 Apr 2011
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Nicklas TA, Qu H, Hughes SO, Wagner SE, Foushee R, Shewchuk RM. Prevalence of Self-reported Lactose Intolerance in a Multi-ethnic Sample of Adults. Nutrition Today 44(5):222-227, 2009
Nicklas TA, Qu H, Hughes SO, He M, Wagner SE, Foushee HR, Shewchuk RM. Self-perceived lactose intolerance results in lower intakes of calcium and dairy foods and is associated with hypertension and diabetes in adults. Am J Clin Nutr. 2011 Jul;94(1):191-8. doi: 10.3945/ajcn.110.009860. Epub 2011 Apr 27.
PubMed 21525197
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Perceived Lactose Intolerance in White, Black, and Hispanic Adults
- ClinicalTrials.gov ID
- NCT01331265
- Acronym / sponsor ID
- H-22651
- Conditions
- Lactose Intolerance
- Keywords
- perceived lactose intolerance, calcium/dairy consumption, specific health outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,815 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Study start
- Jan 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 8 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study was to examine the effects of self-perceived lactose intolerance (SPLI) as it relates to calcium intake and specific health problems that have been attributed to reduced intake of calcium and foods from the dairy group in a nationally representative multi-ethnic sample of adults.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| no treatment | – | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- white, black, and Hispanic adults; 18-50 years of age
Key inclusion criteria (1 listed)
- adults between 18 and 50 years old
Key exclusion criteria (1 listed)
- pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Results publicationNicklas TA, Qu H, Hughes SO, Wagner SE, Foushee R, Shewchuk RM. Prevalence of Self-reported Lactose Intolerance in a Multi-ethnic Sample of Adults. Nutrition Today 44(5):222-227, 2009
- Results publication: PubMed 21525197Nicklas TA, Qu H, Hughes SO, He M, Wagner SE, Foushee HR, Shewchuk RM. Self-perceived lactose intolerance results in lower intakes of calcium and dairy foods and is associated with hypertension and diabetes in adults. Am J Clin Nutr. 2011 Jul;94(1):191-8. doi: 10.3945/ajcn.110.009860. Epub 2011 Apr 27.
Related trials for Lactose Intolerance
Not yet recruiting
Partially Hydrolysed Whey Based Formula in Differentiation Between Non IgE Gastrointestinal Cow's Milk Protein Allergy and Milk Intolerance
Cow Milk Protein Allergy, Cow Milk Intolerance
Recruiting
Milk for Diabetes Prevention
Lactose Intolerance, Lactose Intolerant
Enrolling by invitationObservational study
Lactose Intolerance and Intestinal Permability
Lactose Intolerance, Adult Type, Intestinal Permability
Not yet recruitingObservational study
Screening of Lactose Intolerance Among IBS Patients Diarrhea Dominant
Lactose Intolerance
RecruitingPhase 3
Efficacy of a Low FODMAP Diet in the Absence of Lactose Malabsorption in Moderate to Severe ROME IV IBS.
Irritable Bowel Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lactose Intolerance, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01331265, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.