The primary objective of this study is to assess whether repetitive consumption of an increasing dose of dietary lactose in LNPers induces colonic microbial adaptation by a shift in microbiota composition and functional potential as measured with…
ID
Source
Brief title
Condition
- Gastrointestinal signs and symptoms
- Food intolerance syndromes
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Globally, about 70 percent of the adult population is lactase non-persistent
(LNP), lacking the enzyme required for the digestion of lactose. It has been
shown that most of the LNPers can still consume 12 grams (or more) of lactose
in a single dose without suffering from any gastrointestinal (GI) discomfort.
Dietary lactose might improve intolerance symptoms via the process of colonic
adaptation. This study could provide insight into the threshold levels of
repetitive dietary lactose needed to observe colonic adaptation and into what
positive health effects the intake of lactose may have when colonic adaptation
occurs.
Study objective
The primary objective of this study is to assess whether repetitive consumption
of an increasing dose of dietary lactose in LNPers induces colonic microbial
adaptation by a shift in microbiota composition and functional potential as
measured with shotgun metagenomic sequencing. The secondary objective is to
assess whether repetitive consumption of an increasing dose of dietary lactose
in LNPers results in decreased symptoms of lactose intolerance, by measurements
such as hydrogen breath test, fecal lactase activity, and GI comfort.
Study design
This study will consist of a dose-response single-blinded intervention study,
with three consecutive 4 week intervention periods.
Intervention
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: twice a day respectively 3 grams, 6
grams, and 12 grams of lactose. This will result in a total daily lactose dose
of 6, 12, and 24 grams, respectively.
Study burden and risks
The risks associated with participation are limited. The study participants can
experience some GI discomfort, but the maximal intervention dose of lactose is
chosen in such a way that expected lactose intolerance symptoms are limited.
The study participants will have to visit the research facility in total 10
times (including information meeting) for screening, to pick-up the
intervention product, to hand-in stool samples, and for two hydrogen breath
tests. Study participants are furthermore requested to fill out daily GI
comfort and stool pattern questionnaires via an app, and record their food
intake with a 72-hour food diary at the beginning and ending of the study.
Bornse Weilanden 9
Wageningen 6708 WG
NL
Bornse Weilanden 9
Wageningen 6708 WG
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL74025.081.20 |
| Other | Nog in bewerking |