The effect of Galacto-oligosaccharides (GOS) on self-perceived stress in apparently healthy but stressed Dutch women: randomized controlled study

The effect of Galacto-oligosaccharides (GOS) on self-perceived stress in apparently healthy but stressed Dutch women: randomized controlled study - Prebiotics and stress reduction in women

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51276

Enrollment

120

Registered

2022-01-31

Start date

2022-02-17

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Stress self-perceived stress stress

Interventions

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

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)