The main objective of this study is to assess the effect of GOS in combination with 2*-FL on perceived stress. The secondary objective is to assess the effect of GOS in combination with 2-FL on saliva cortisol levels, as well as on perceived anxiety…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Stress
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess the effect of 28-days consumption of GOSplus on the DASS42 derived
stress sub-score in a population of healthy Dutch women (25-45 years), who
perceive stress on a regular basis, compared to a placebo (maltodextrin).
Secondary outcome
To assess the effect of 14 days consumption of GOSplus on the DASS42 derived
stress sub-score, compared to a placebo (maltodextrin).
To assess the effect of 28- and 14-days consumption of GOSplus on the DASS42
derived anxiety sub-score, compared to a placebo (maltodextrin).
To assess the effect of 28 days consumption of GOSplus on early morning
cortisol levels in saliva, compared to placebo (maltodextrin).
To assess the effect of 28- and 14-days consumption of GOSplus, or
maltodextrin, on the changes (baseline versus endline) in DASS42 derived stress
and anxiety sub-score, and early morning cortisol levels in saliva.
Background summary
In modern life, many people state to experience stress. Women compared to men
report more and higher levels of stress. Recent research found that
supplementation of galactose-oligosaccharides (GOS) resulted in reduced anxiety
levels in British female students with higher anxiety scores at baseline in
self-reported trait anxiety. Moreover, supplementation of probiotics in
germ-free rodents resulted in reduced levels of circulating corticosterone
(cortisol in humans). These findings illustrate the potential of prebiotic
supplementation, through the microbiota-gut-brain (MGB) axis, to improve mental
health and wellbeing.
The present study aims to study the effect of GOS and 2'-FL on self-perceived
stress.
Study objective
The main objective of this study is to assess the effect of GOS in combination
with 2*-FL on perceived stress. The secondary objective is to assess the effect
of GOS in combination with 2-FL on saliva cortisol levels, as well as on
perceived anxiety .
Study design
The study is double-blind randomized placebo controlled.
Intervention
The participants will consume GOSplus (5.0 g BiotisTMGOS + 0.5 g 2*-FL) or a
placebo (5.5 g maltodextrin) daily during the first consumption moment of the
day (preferably in the morning) for 28 days.
Study burden and risks
The risk for the present study is limited. The burden (filling in
questionnaires and taking saliva) is very acceptable. On the other hand, if a
positive effect is shown, this is a simple way to improve feelings of stress
through food.
Bronland 20
Wageningen 6708 WH
NL
Bronland 20
Wageningen 6708 WH
NL
Listed location countries
Age
Inclusion criteria
* Apparently healthy women (based on lifestyle questionnaire)
* Moderate or high stress level; DASS42 stress sub-score *19
* Age between 25 and 45 years
* Body mass index (BMI) between 18.5 and 30 kg/m2
* Access to internet and a smart phone, and willing to install an app
Exclusion criteria
* Any metabolic, gastrointestinal, inflammatory or chronic disease
* History of gastro-intestinal surgery or having (serious) gastrointestinal
discomfort
* Use of supplement to relief stress during or within 2 weeks prior to the
start of the study
* Use of pre- and/or probiotics during the study (except for the study product)
or within 4 weeks prior to the start of the study
* Use of medication that may influence the study results, such as laxatives
* Self-reported and/or clinical lactose intolerance
* Self-reported and/or active cow*s milk protein allergy
* Pregnant or lactating (or having the wish to become pregnant during the study
period, self-reported)
* Having used antibiotics in the 6 months prior to the start of the study
* Being an employee of 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
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL80003.028.21 |