The effect of lactose consumption in lactase non-persistent individuals on gut microbiota
- Conditions
- intestinal discomfortlactose intolerance1001794710016950
- Registration Number
- NL-OMON55015
- Lead Sponsor
- Wageningen Universiteit
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 25
* Apparently healthy men and women
* Asian ethnicity
* Age between 18 and 50 years
* Body mass index (BMI) between 18.5 and 30 kg/m2
* LNP genotype
* Avoiding dietary lactose in habitual diet
* Regular stool frequency (on average at least once every two days)
* Any metabolic, gastrointestinal, inflammatory or chronic disease (such as
diabetes, anaemia, hepatitis, cardiovascular disease)
* History of gastro-intestinal surgery or having (serious) gastrointestinal
discomfort
* Use of pre- and/or probiotics
* Use of medication that may influence the study results, such as laxatives and
lactase peparations (e.g. Kerutab). Use of medication will be judged by the
medical supervisor
* Having used antibiotics in the 6 months prior to the start of the study
* Reported slimming or medically prescribed diet
* Current smokers
* Alcohol intake *2 (women) or *4 (men) glasses of alcoholic beverages per day
* Pregnant or lactating (or having the wish to become pregnant during the study
period, self-reported)
* Abuse of illicit drugs
* Having food allergies (no food intolerances)
* Insufficient proficiency in English to understand information brochure and
questionnaires
* Participation in another clinical trial at the same time
* Being an employee of the department Consumer Science & Health group of
Wageningen Food & Biobased Research, Human Nutrition department of Wageningen
University, or FrieslandCampina.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is the change in fecal microbiota based on shotgun<br /><br>metagenomic sequencing upon repetitive consumption of (an increasing dose of)<br /><br>lactose. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary study parameters are exhaled hydrogen with the hydrogen breath<br />test, stool characteristics (such as pH, microbial lactase activity and dry<br />weight), and GI comfort. </p>