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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON55015
Enrollment
25
Registered
2021-05-25
Start date
2021-08-17
Completion date
Unknown
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intestinal discomfort lactose intolerance

Interventions

During the three consecutive intervention periods the study participants will consume twice a day 12 grams of sugar. This dose will consist of different ratios between beta-lactose and dextrose: twi

Sponsors

Wageningen Universiteit
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
The main study parameter is the change in fecal microbiota based on shotgun metagenomic sequencing upon repetitive consumption of (an increasing dose of) lactose.

Secondary

MeasureTime frame
The secondary study parameters are exhaled hydrogen with the hydrogen breath test, stool characteristics (such as pH, microbial lactase activity and dry weight), and GI comfort.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)