Glycemic IndexIGNCT05204823
Evaluation of the Glycemic Index in 4 Dairy Beverages.
A study testing Experimental product in people with Glycemic Index and Cognitive Performance, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
The objective of the study is to evaluate the glycemic index and glycemic load of 4 chocolate milk drinks. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycemic Index, Cognitive Performance
- What is being tested?
- Experimental product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 6 Dec 2021to 16 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of the study is to evaluate the glycemic index and glycemic load of 4 chocolate milk drinks.
Read the 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.
- Conditions
- Glycemic Index, Cognitive Performance
- Being tested
- Experimental product, Control product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental productOther
Chocolate milk shakes
Control productOther
Glucose
| Study group | Role | What they receive |
|---|---|---|
| Experimental Product 1 | Experimental | 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. Receives: Other: Experimental product |
| Experimental Product 2 | Experimental | 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. Receives: Other: Experimental product |
| Experimental Product 3 | Experimental | 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. Receives: Other: Experimental product |
| Experimental Product 4 | Experimental | 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. Receives: Other: Experimental product |
| Control product | Active comparator | Consumption of 25g of glucose. Subjects will take this amount only on the day of the visit that they are to consume this product. Receives: Other: Control product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose
It will be evaluated by means of a glucometer.
Measured: The glucose evolution will be measured for 210 minutes after product consumption.
Secondary outcomes (1)
Glucose
It will be evaluated by means of a glucometer.
Measured: Each product will be measured at 15, 30, 45, 60, 90, 120 and 150 minutes after consumption.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start6 Dec 2021
- Primary completion28 Jan 2022
- Study completion16 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycemic IndexStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Javier López Román, Universidad Católica San Antonio de Murcia
- Investigators
- Fco Javier López Román, Principal investigator, Catholic University of Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204823
- Sponsor's protocol ID
- UCAMCFE-00023
- Acronym
- IG
- Status last verified
- Nov 2021
- First submitted
- 22 Dec 2021
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Glycemic Index in 4 Dairy Beverages.
- ClinicalTrials.gov ID
- NCT05204823
- Acronym / sponsor ID
- IG / UCAMCFE-00023
- Conditions
- Glycemic Index, Cognitive Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 28 Jan 2022 (actual)
- Study completion
- 16 May 2022 (actual)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to evaluate the glycemic index and glycemic load of 4 chocolate milk drinks.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Experimental Product 1 | Experimental | Other: Experimental productConsumption 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. |
| Experimental Product 2 | Experimental | Other: Experimental productConsumption 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. |
| Experimental Product 3 | Experimental | Other: Experimental productConsumption 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. |
| Experimental Product 4 | Experimental | Other: Experimental productConsumption 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. |
| Control product | Active comparator | Other: Control productConsumption of 25g of glucose. Subjects will take this amount only on the day of the visit that they are to consume this product. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental productChocolate milk shakes | Other | Experimental Product 1, Experimental Product 2, Experimental Product 3, Experimental Product 4 |
| Control productGlucose | Other | Control product |
Primary outcome
Glucose
Time frame: The glucose evolution will be measured for 210 minutes after product consumption.
It will be evaluated by means of a glucometer.
1 secondary outcome
Glucose
Time frame: Each product will be measured at 15, 30, 45, 60, 90, 120 and 150 minutes after consumption.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fco Javier López Román principal investigator
Catholic University of Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental product in people with Glycemic Index and Cognitive Performance, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose (time frame: The glucose evolution will be measured for 210 minutes after product consumption.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.