Evaluation of Cognitive Performance in 4 Dairy Beverages (COG)

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

Study Overview

• Status: Completed
• Conditions: Cognitive Performance
• Intervention / Treatment: Other: Chocolate milk shakes - Product 1; Other: Chocolate milk shakes - Product 2; Other: Chocolate milk shakes - Product 3; Other: Chocolate milk shakes - Product 4

Detailed Description

Subjects will make a total of 4 visits. Four visits in which they will drink a chocolate milkshake at each visit.

At each visit the subjects will have to come fasting, and they will have to perform the cognitive test at the time when they have their peak glycemic level.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30107
    • Catholic University of Murcia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Product 1; 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; 11.3 glucose
Experimental: Experimental Product 2; 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; 8.84 glucose
Experimental: Experimental Product 3; 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; 4.24 glucose
Experimental: Experimental Product 4; 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; 4.36 glucose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression, Anxiety and Stress	DASS21 test	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	Pittsburgh test	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.

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia
• Investigators: Principal Investigator: Fco Javier López Román, Catholic University of Murcia

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2022
• Primary Completion (Actual): April 29, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: January 23, 2022
• First Submitted That Met QC Criteria: February 16, 2022
• First Posted (Actual): February 17, 2022

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 15, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: UCAMCFE-00024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No