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The effect of lactose consumption in lactase non-persistent individuals on gut microbiota

Recruiting
Conditions
intestinal discomfort
lactose intolerance
10017947
10016950
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
Inclusion Criteria

* 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)

Exclusion Criteria

* 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
NameTimeMethod
<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
NameTimeMethod
<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>
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