Evaluation of the Glycemic Index in 4 Dairy Beverages. (IG)

The objective of the study is to evaluate the glycemic index and glycemic load of 4 chocolate milk drinks.

Study Overview

• Status: Completed
• Conditions: Glycemic Index; Cognitive Performance
• Intervention / Treatment: Other: Experimental product; Other: Control product

Detailed Description

Subjects will make a total of 5 visits. Four visits where they will drink a chocolate milkshake at each visit. In the other visit they will take glucose, as a comparator product.

Due to the low amount of sugars in the shakes, subjects will drink the equivalent of 25g of glucose.

At each visit subjects will have to come fasting, and samples will be collected at 9 different times.

• 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: No
• 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: Crossover Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Product 1; Consumption of 221.24 ml of product 1 (corresponding to 25g of glucose). Subjects will take this amount only on the day of the visit that they are to consume this product.	Other: Experimental product; Chocolate milk shakes
Experimental: Experimental Product 2; Consumption of 282.81 ml of product 1 (corresponding to 25g of glucose). Subjects will take this amount only on the day of the visit that they are to consume this product.	Other: Experimental product; Chocolate milk shakes
Experimental: Experimental Product 3; Consumption of 589,62 ml of product 1 (corresponding to 25g of glucose). Subjects will take this amount only on the day of the visit that they are to consume this product.	Other: Experimental product; Chocolate milk shakes
Experimental: Experimental Product 4; Consumption of 573,39 ml of product 1 (corresponding to 25g of glucose). Subjects will take this amount only on the day of the visit that they are to consume this product.	Other: Experimental product; Chocolate milk shakes
Active Comparator: Control product; Consumption of 25g of glucose. Subjects will take this amount only on the day of the visit that they are to consume this product.	Other: Control product; Glucose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose	It will be evaluated by means of a glucometer.	The glucose evolution will be measured for 210 minutes after product consumption.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose	It will be evaluated by means of a glucometer.	Each product will be measured at 15, 30, 45, 60, 90, 120 and 150 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): December 6, 2021
• Primary Completion (Actual): January 28, 2022
• Study Completion (Actual): May 16, 2022

Study Registration Dates

• First Submitted: December 22, 2021
• First Submitted That Met QC Criteria: January 10, 2022
• First Posted (Actual): January 24, 2022

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 15, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: UCAMCFE-00023

Drug and device information, study documents

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