The primary objective is to investigate the effect of a 3 week intervention with either 1.,3 gram or 2 gram of GOS on the abundance of the genus Bifidobacterium in faecal samples in healthy women of 40 - 70 years old. The secondary objective is to…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
n.v.t.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the absolute abundance of faecal Bifidobacterium.
Secondary outcome
The secondary study parameters are faecal microbiota composition. Tertiary
Objectives are gastrointestinal (GI) comfort, sleep quality (Athens Insomnia
scale), well-being and stress (DASS-21).
Background summary
Gut microbiota homeostasis is important for maintaining overall human health.
The ageing process is associated with a loss of microbiota diversity, with a
reducing proportion of beneficial bacteria, including bifidobacteria.
Disturbances in gut microbiota are associated with several medical conditions.
Acting as substrates, prebiotics as part of a dietary habit can support the gut
microbiota composition. However most of the clinical proof comes from studies
done with higher dosages of prebiotics and data on the effect of low dosages
are limited. Low dosages have the benefit that they can be incorporated in a
tablet or capsule. Even though supplements are not a substitute for a balanced
healthy diet, they might support people to fulfil the daily nutrient
requirements and contribute to (gastrointestinal) health and wellbeing.
Therefore, there is a need for scientifically substantiated insights into the
effect of low dosages of prebiotics on the gut microbiota composition
Study objective
The primary objective is to investigate the effect of a 3 week intervention
with either 1.,3 gram or 2 gram of GOS on the abundance of the genus
Bifidobacterium in faecal samples in healthy women of 40 - 70 years old. The
secondary objective is to determine the effect of both interventions (dose of 2
-gram and 1.,3 -gram) on faecal microbiota composition in healthy women of 40 -
70 years old. Tertiary objective is to investigate the effect both
interventions (dose of 2- gram and 1.,3 gram) on subjective measures of GI
comfort, sleep quality, well-being and stress. Interest is in the within-group
effects only; the two different groups will not be compared with each other.
Study design
The study has a randomized, double-blind design of 6 weeks (3 weeks control + 3
weeks intervention).
Intervention
Subjects receive 1 sachet of GOS (1.3 or 2 grams) per day. They have to
dissolve this in a product of their choice (water, yogurt, milk, tea, coffee,
custard) at breakfast. Subjects are instructed to dissolve the sachets in a
product the are used to consume during breakfast, to avoid unintended changes
in diet during the study.
Study burden and risks
Study participants have to invest about 12 hours of their time in this study
mainly to complete several questionnaires (weekly online questionnaire), which
is conveniently all possible from home. On three occasions they have to record
their food intake in an app and to collect a faecal sample. They have to comply
to consume an intervention product once a day for three weeks. Furthermore,
they have to visit the Research unit twice. There are minor risks for the
participants of this study (bloating and flatulence). There are no direct
benefits for the participants.
Bornse Weilanden 9
Wageningen 6708WG
NL
Bornse Weilanden 9
Wageningen 6708WG
NL
Listed location countries
Age
Inclusion criteria
- Apparently healthy women (based on screening questionnaire), living in the
surrounding of Wageningen (+50 km )
- Aged between 40 - 70 year
- Body Mass Index (BMI) between 18,5 - 30 kg/m2
Exclusion criteria
- Having a gastro-intestinal disease, such as celiac disease, Crohn*s disease,
Ulcerative colitis, or diagnosed irritable bowel disease;
- Having a history of intestinal surgery that might interfere with study
outcomes. This does not include an appendectomy or cholecystectomy;
- Diagnosed with diabetes mellitus; Use of medication that may influence the
study results, such as laxatives, lactase preparations, metformin, antibiotics,
proton pomp inhibitors, antipsychotics, NSAID*s (judged by our research
physician);
- Self-perceived or diagnosed constipation;
- Having a food allergy to cow*s milk or being lactose intolerant;
- Reported slimming, medically prescribed or other diets
- Reported weight loss or weight gain of >5kg in the month prior to screening
- Use of pre-, pro- , syn- and/or postbiotics (should be stopped at least 4
weeks before the start of the study), or other supplements that can influence
the study results (to be determined by the medical investigator);
- History of side effects with the use of prebiotic supplements
- Use of antibiotic treatment less than 3 months before start of the study
- Pregnant or lactating (or having the wish to become pregnant during the study
period, self-reported);
- Not able to comply with study procedures;
- Abuse of drugs (should be stopped at least 4 weeks before the study);
- Alcohol intake >=7 glasses of alcoholic beverages per week, on average
- Participation in another clinical trial at the same time;
- Being an employee of the Food, Health & Consumer Research group of Wageningen
Food & Biobased Research or employee of FrieslandCampina R&D.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL81854.091.22 |