Last reviewed · How we verify
NCT05372601
Prebiotics and Stress Reduction in Women
NA trial testing Relax+ in Stress, Psychological in 124 participants. Completed in 18 June 2022.
18 June 2022
Quick facts
| Lead sponsor | FrieslandCampina |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 124 |
| Start date | 17 February 2022 |
| Primary completion | 18 June 2022 |
| Estimated completion | 18 June 2022 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- Relax+
- Maltodextrin (MALTODEXTRIN) — full drug profile →
Conditions studied
- Stress, Psychological — all drugs for Stress, Psychological →
Sponsor
FrieslandCampina — full company profile →
Who can join
Adults 25 to 45, female only, with Stress, Psychological. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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 oligosaccharides on self-perceived stress.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Gut Microbiome-Brain Alliance: A Landscape View into Mental and Gastrointestinal Health and Disorders.
Sasso JM, Ammar RM, Tenchov R, Lemmel S, et al · · 2023 · cited 100× · PMID 37156006 · DOI 10.1021/acschemneuro.3c00127
Verify or expand the search:
- PubMed search for NCT05372601
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other FrieslandCampina trials
Trials by the same sponsor.
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- NCT06251427 — Assessing the Effectiveness of a Multiple-micronutrient Fortified Maize Pap on the Nutrient Status of Nigerian School-ag · NA · completed
- NCT05813769 — Dairy and Plant Amino Acid Uptake. An Explorative Study · NA · completed
- NCT05670002 — Nutrition Intervention of Complementary Milk Feeding to Improve Linear Growth of at Risk and Stunted Children · NA · completed
- NCT05418491 — The Prolonged Effect of Consumption of a Partially Hydrolyzed Infant Formula During the First 6 Months of Life on the De · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05372601 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by FrieslandCampina
- Last refreshed: 4 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05372601.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing