The effect of dietary lactose in lactase non-persistent individuals on gut microbiota
- Conditions
- actose intolerance
- Registration Number
- NL-OMON23633
- Lead Sponsor
- Wageningen Food & Biobased Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25
• Apparently healthy men and women (based on questionnaire)
• Asian ethnicity
• Age between 18 and 50 years
• Body mass index (BMI) between 18.5 and 30 kg/m2
• LNP genotype (based on buccal swab testing)
• Avoiding dietary lactose in habitual diet (self-reported via questionnaire)
• 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), judged by the medical doctor
• 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 preparations (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 (food intolerances are acceptable)
• 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 The change in fecal microbiota based on shotgun metagenomic sequencing
- Secondary Outcome Measures
Name Time Method Exhaled hydrogen measured with the hydrogen breath test, stool characteristics and GI comfort.