NCT06138470

Brief Summary

The aim of this study is to confirm by a randomized double-blind controlled study the interest of a combination of saffron (Saffr'Activ®) and scutellaria (Scutell'up®) on the regulation of mood.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

January 29, 2025

Status Verified

January 1, 2025

Enrollment Period

2.2 years

First QC Date

November 14, 2023

Last Update Submit

January 28, 2025

Conditions

Mood Regulation

Outcome Measures

Primary Outcomes (1)

  • Evaluated mood regulation

    observe a difference of the Beck Inventory Depression (BDI) score (adjusted for baseline), after 6 weeks of supplementation. All items are scored on a 4-point scale, ranging from 0 to 3.

    Baseline and 6 weeks

Secondary Outcomes (2)

  • Evaluated mood regulation

    3 and 6 weeks of intervention and after 2 weeks after the end of intervention

  • Evaluated mood regulation

    after 3 and 6 weeks of intervention and after 2 weeks after the end of intervention

Study Arms (4)

Saffron extract

ACTIVE COMPARATOR
Dietary Supplement: Saffron extract

Scutellaria baicalensis extract

ACTIVE COMPARATOR
Dietary Supplement: Scutellaria baicalensis extract

Saffron and Scutellaria baicalensis extract

ACTIVE COMPARATOR
Dietary Supplement: Saffron and Scutellaria baicalensis extract

Placebo (maltodextrin)

PLACEBO COMPARATOR
Dietary Supplement: Placebo (maltodextrin)

Interventions

Saffron extractDIETARY_SUPPLEMENT

Food supplements are taken during 6 weeks by healthy volunteers

Saffron extract
Scutellaria baicalensis extractDIETARY_SUPPLEMENT

Food supplements are taken during 6 weeks by healthy volunteers

Scutellaria baicalensis extract
Saffron and Scutellaria baicalensis extractDIETARY_SUPPLEMENT

Food supplements are taken during 6 weeks by healthy volunteers

Saffron and Scutellaria baicalensis extract
Placebo (maltodextrin)DIETARY_SUPPLEMENT

Food supplements are taken during 6 weeks by healthy volunteers

Placebo (maltodextrin)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Woman or man, aged of 18 to 75 years;
  • Participant presenting a depressive episode, according to the DSM-5 definition;
  • Participant with a recent episode of depression (less than 2 years), not managed by antidepressant or psychotherapeutic treatment;
  • Participant with a current depressive disorder not requiring, in the investigator's opinion, the initiation of antidepressant medication;
  • Provision of signed and dated informed consent form;
  • Stated willingness to comply with all study procedures and availability for the duration of the study;
  • French speaker.

You may not qualify if:

  • Participant with a depressive disorder of another nature or any other mental pathology (schizophrenia, bipolarity, addiction to alcohol or drugs...);
  • Participant at risk of suicide (determined by the Investigator, or HAMD item 3 score \> 2) or having made a suicide attempt in the last 5 years;
  • Participant with depression for more than 2 years;
  • Participant with a serious health problem for which the Investigator considers that it is not in the participant's interest to participate in the study;
  • Participant using products containing piperine or millpertuis, or having a known effect on mood within the last 4 weeks;
  • Pregnant or breastfeeding women, or those planning to become pregnant within the next 8 weeks;
  • Participant with an allergy or contraindication to any component of the study drug;
  • Participant unable to understand study information (mental or linguistic disability);
  • Participant who is participating or has participated in the previous month in another clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université Catholique de Louvain, CICN

Ottignies-Louvain-la-Neuve, 1348, Belgium

Location

MeSH Terms

Interventions

Scutellaria baicalensis extractmaltodextrin

Study Officials

  • Valérie Dormal, PhD

    Université Catholique de Louvain

    STUDY CHAIR

  • Louise Deldicque, Pr

    Université Catholique de Louvain

    STUDY DIRECTOR

  • Laurent Simar, Dr

    Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2023

First Posted

November 18, 2023

Study Start

May 30, 2022

Primary Completion

July 30, 2024

Study Completion

September 30, 2024

Last Updated

January 29, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)