NCT05245188

Brief Summary

The objective of the study is to evaluate the cognitive performance of 4 chocolate milk drinks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 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

January 23, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

January 31, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 17, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

June 21, 2022

Status Verified

January 1, 2022

Enrollment Period

3 months

First QC Date

January 23, 2022

Last Update Submit

June 15, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cognitive performance

    COMPASS cognitive test panel

    The test was carried out half an hour after consumption of the product, except for product 4, which was carried out 15 minutes after consumption.

Secondary Outcomes (2)

  • Depression, Anxiety and Stress

    The test was carried out half an hour after consumption of the product, except for product 4, which was carried out 15 minutes after consumption.

  • Sleep quality

    The test was carried out half an hour after consumption of the product, except for product 4, which was carried out 15 minutes after consumption.

Study Arms (4)

Experimental Product 1

EXPERIMENTAL

Consumption of 200 ml of product 1. Subjects will take this amount only on the day of the visit that they are to consume this product.

Other: Chocolate milk shakes - Product 1

Experimental Product 2

EXPERIMENTAL

Consumption of 200 ml of product 2. Subjects will take this amount only on the day of the visit that they are to consume this product.

Other: Chocolate milk shakes - Product 2

Experimental Product 3

EXPERIMENTAL

Consumption of 200 ml of product 3. Subjects will take this amount only on the day of the visit that they are to consume this product.

Other: Chocolate milk shakes - Product 3

Experimental Product 4

EXPERIMENTAL

Consumption of 200 ml of product 4. Subjects will take this amount only on the day of the visit that they are to consume this product.

Other: Chocolate milk shakes - Product 4

Interventions

11.3 glucose

Experimental Product 1

8.84 glucose

Experimental Product 2

4.24 glucose

Experimental Product 3

4.36 glucose

Experimental Product 4

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects of both sexes (10 men and 10 women).
  • Subjects aged between 20 and 35 years.
  • Subjects with a body mass index between 20 and 25 kg/m2.

You may not qualify if:

  • Subjects suffering from diabetes mellitus or any chronic disease.
  • Subjects with medical problems or a diagnosed psychiatric disorder.
  • Subjects with alcohol abuse or excessive alcohol consumption (\>3 glasses of wine or beer/day).
  • Subjects consuming any pharmacological medication that may affect memory.
  • Participation in another clinical trial in the three months prior to the study.
  • Unwillingness or inability to comply with clinical trial procedures.
  • Subjects whose condition does not make them eligible for the study according to the investigator's criteria.
  • Pregnant or lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University of Murcia

Murcia, 30107, Spain

Location

Study Officials

  • Fco Javier López Román

    Catholic University of Murcia

    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
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 23, 2022

First Posted

February 17, 2022

Study Start

January 31, 2022

Primary Completion

April 29, 2022

Study Completion

June 1, 2022

Last Updated

June 21, 2022

Record last verified: 2022-01

Locations