NCT05323825

Brief Summary

Single-center, randomized, double-blind, placebo-controlled clinical study with two study groups. One group will consume a product with functional ingredients and the other group will consume a placebo product. will consume a placebo product.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 12, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

April 25, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2023

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2023

Completed
Last Updated

June 18, 2023

Status Verified

March 1, 2022

Enrollment Period

9 months

First QC Date

March 26, 2022

Last Update Submit

June 15, 2023

Conditions

Cognitive Change

Keywords

ProbioticFermented milk

Outcome Measures

Primary Outcomes (1)

  • Cognitive performance

    COMPASS cognitive test panel

    Change in baseline cognitive performance after 8 weeks of consumption

Secondary Outcomes (13)

  • Perceived Stress Scale

    Day 1, at 4 and 8 weeks later

  • Mood profile

    Day 1, at 4 and 8 weeks later

  • Depression, Anxiety and Stress

    Day 1, at 4 and 8 weeks later

  • State of mind

    Day 1, at 4 and 8 weeks later

  • Stress status using VAS scale

    Day 1, at 4 and 8 weeks later

  • +8 more secondary outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL

The content of the package is 100 g and should be consumed once a day for 8 weeks.

Dietary Supplement: Probiotic

Control group

PLACEBO COMPARATOR

The content of the package is 100 g and should be consumed once a day for 8 weeks.

Dietary Supplement: Placebo

Interventions

ProbioticDIETARY_SUPPLEMENT

Fermented milk product containing a probiotic

Experimental group
PlaceboDIETARY_SUPPLEMENT

Product with identical characteristics to the experimental product.

Control group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men and women aged 18-60 years.
  • Individuals with a diagnosis of mild-moderate stress according to the Cohen's perceived stress scale perceived stress scale (PSS-10).
  • Subjects with poor adherence to the Mediterranean diet according to the PREDIMED questionnaire (value below 9 points)\*.
  • BMI between 19 and 30 kg/m2.

You may not qualify if:

  • Present chronic and/or acute digestive pathologies that may interfere in the absorption of nutrients (inflammatory intestinal diseases, inflammatory bowel absorption of nutrients (inflammatory intestinal diseases, etc.), etc.)
  • Vegan diet.
  • Being taking any type of supplementation that interacts with cognitive level in the 2 weeks prior to the start of the study.
  • Individuals who had taken or were taking any medications or supplementation for stress management, mood, or to induce sleep in the 2 weeks prior to the start of the study.
  • A history of allergic hypersensitivity or poor tolerance to any component of the products under study.
  • Consumption of 2 or more Standard Drink Units (UBE) daily or 17 weekly in women, or consume 4 or more UBE daily or 28 weekly in men.
  • Smoking and non-smoking subjects who have modified their nicotinic habits in the last 3 months.
  • Pregnant or lactating women.
  • Been participating or have participated in another clinical trial in the 2 months prior to the study to the study.
  • Unwillingness or inability to comply with the procedures of the clinical trial.
  • Subjects with any diagnosed psychiatric disorder.
  • Subjects whose condition makes them ineligible for the study in accordance with the criteria of the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University of Murcia

Murcia, 30107, Spain

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Fco Javier López Román

    Catholic University of Murcia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 26, 2022

First Posted

April 12, 2022

Study Start

April 25, 2022

Primary Completion

January 16, 2023

Study Completion

January 25, 2023

Last Updated

June 18, 2023

Record last verified: 2022-03

Locations

ES(1)