Glucose Metabolism DisordersBEGINSNCT06358716
Glycaemic Index Determination in Oral Nutrition Supplements
A study testing Complete Oral Nutrition Supplement 1, Complete Oral Nutrition Supplement 2 and Complete Oral Nutrition Supplement 3 in people with Glucose Metabolism Disorders, run by Universitat de Lleida at 1 site in Spain.
Trial summary
The glycemic index is the ability of carbohydrates in foods to induce increases in blood glucose levels after consuming them. Based on the capacity for increasing blood glucose levels, foods can be classified as having a low, medium, or high glycemic index. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Metabolism Disorders
- What is being tested?
- Complete Oral Nutrition Supplement 1, Complete Oral Nutrition Supplement 2 and Complete Oral Nutrition Supplement 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- 15 Apr 2024to 15 Aug 2024
- 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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers with no known food allergy or intolerance and pharmacological treatments known to affect glucose tolerance (excluding oral contraceptives)
Who cannot join
- Known history of diabetes mellitus or the use of antihyperglycemic drugs or insulin to treat diabetes and related conditions.
- Any acute, chronic disease or any other serious complications that may interfere with glucose metabolism.
- Subjects using any medication (eg steroids, protease inhibitors or antipsychotics, etc.) that would interfere with the digestion and nutrient absorption.
- Subjects having gastrointestinal diseases that may interfere with nutrient absorption, distribution, metabolism, excretion
- A major medical or surgical event requiring hospitalization within the preceding 3 months.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
University of Lleida
Lleida, 25198
Jose Serrano, PhD, 973702408, josecarlos.serrano@udl.cat
Manuel Portero, PhD, 973702408, manuel.portero@udl.cat
About this study
The glycemic index is the ability of carbohydrates in foods to induce increases in blood glucose levels after consuming them. Based on the capacity for increasing blood glucose levels, foods can be classified as having a low, medium, or high glycemic index. This property is of interest in health and nutrition because it allows estimating the impact the food will have on postprandial glycemia, which may able better food selection in situations where adequate glycemic control is required, such as in individuals diagnosed with Diabetes Mellitus. The objective of this study is to determine the glycemic index of 9 formulations of complete oral nutrition supplements and classify them based on their glycemic response.
Read the detailed description
The determination of the glycemic index will be conducted following the protocol described in the International Standard Organization 26642. Specifically, the glycemic response of each food will be determined in 15 healthy volunteers, using a glucose-containing beverage with 25 g of glucose in 200 mL as a control for glycemic response measurement. The amount of food each volunteer will test will be equivalent to an intake of 25 g of digestible carbohydrates in a single intake. Subsequently, increases in blood glucose levels will be recorded at 15, 30, 45, 60, 90, and 120 minutes after initiating the food intake. Blood glucose measurements will be performed using a portable glucometer via capillary blood. The area under the curve of the increase in glucemia will be estimated using the trapezoidal method, and these will be compared with the glucose increases provided by the glucose-containing beverage.
- Conditions
- Glucose Metabolism Disorders
- Being tested
- Complete Oral Nutrition Supplement 1, Complete Oral Nutrition Supplement 2, Complete Oral Nutrition Supplement 3, Complete Oral Nutrition Supplement 4, Complete Oral Nutrition Supplement 5
- Keywords
- Glycemic index, Glucose, Post-prandial, Digestible carbohydrates
- Medical subject headings
- Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete Oral Nutrition Supplement 1Dietary supplement
Liquid formula produced by several food ingredients to provide a balance nutrient intake
Complete Oral Nutrition Supplement 2Dietary supplement
Liquid formula produced by several food ingredients to provide a balance nutrient intake
Complete Oral Nutrition Supplement 3Dietary supplement
Liquid formula produced by several food ingredients to provide a balance nutrient intake
Complete Oral Nutrition Supplement 4Dietary supplement
Liquid formula produced by several food ingredients to provide a balance nutrient intake
Complete Oral Nutrition Supplement 5Dietary supplement
Liquid formula produced by several food ingredients to provide a balance nutrient intake
Complete Oral Nutrition Supplement 6Dietary supplement
Liquid formula produced by several food ingredients to provide a balance nutrient intake
Complete Oral Nutrition Supplement 7Dietary supplement
Liquid formula produced by several food ingredients to provide a balance nutrient intake
Complete Oral Nutrition Supplement 8Dietary supplement
Liquid formula produced by several food ingredients to provide a balance nutrient intake
Complete Oral Nutrition Supplement 9Dietary supplement
Liquid formula produced by several food ingredients to provide a balance nutrient intake
GlucoseDietary supplement
25 mg of glucose dissolved in 200 mL
| Study group | Role | What they receive |
|---|---|---|
| Oral Nutritional Supplement 1 | Experimental | Oral Nutritional Supplement 1 Receives: Dietary Supplement: Complete Oral Nutrition Supplement 1 |
| Oral Nutritional Supplement 2 | Experimental | Oral Nutritional Supplement 2 Receives: Dietary Supplement: Complete Oral Nutrition Supplement 2 |
| Oral Nutritional Supplement 3 | Experimental | Oral Nutritional Supplement 3 Receives: Dietary Supplement: Complete Oral Nutrition Supplement 3 |
| Oral Nutritional Supplement 4 | Experimental | Oral Nutritional Supplement 4 Receives: Dietary Supplement: Complete Oral Nutrition Supplement 4 |
| Oral Nutritional Supplement 5 | Experimental | Oral Nutritional Supplement 5 Receives: Dietary Supplement: Complete Oral Nutrition Supplement 5 |
| Oral Nutritional Supplement 6 | Experimental | Oral Nutritional Supplement 6 Receives: Dietary Supplement: Complete Oral Nutrition Supplement 6 |
| Oral Nutritional Supplement 7 | Experimental | Oral Nutritional Supplement 7 Receives: Dietary Supplement: Complete Oral Nutrition Supplement 7 |
| Oral Nutritional Supplement 8 | Experimental | Oral Nutritional Supplement 8 Receives: Dietary Supplement: Complete Oral Nutrition Supplement 8 |
| Oral Nutritional Supplement 9 | Experimental | Oral Nutritional Supplement 9 Receives: Dietary Supplement: Complete Oral Nutrition Supplement 9 |
| Glucose | Active comparator | Glucose solution Receives: Dietary Supplement: Glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Index
The area under the curve of glucose levels after the post-prandial intake of the oral nutrition supplement compared with the area under the curve of glucose levels after a post-prandial intake of a glucose solution
Measured: Post-prandial until 120 minutes after food intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start15 Apr 2024 (estimated)
- Primary completion15 Jul 2024 (estimated)
- Study completion15 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose Metabolism DisordersStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat de Lleida
- Sponsor type
- University, hospital or other
- Collaborators
- Lactalis
- Responsible party
- Principal investigator, José Serrano, Universitat de Lleida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06358716
- Sponsor's protocol ID
- CEIC-3037
- Acronym
- BEGINS
- Status last verified
- Apr 2024
- First submitted
- 5 Apr 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycaemic Index Determination in Oral Nutrition Supplements
- ClinicalTrials.gov ID
- NCT06358716
- Acronym / sponsor ID
- BEGINS / CEIC-3037
- Conditions
- Glucose Metabolism Disorders
- Keywords
- Glycemic index, Glucose, Post-prandial, Digestible carbohydrates
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Universitat de LleidaUniversity, hospital or other
- Collaborators
- Lactalis
- Study start
- 15 Apr 2024 (estimated)
- Primary completion
- 15 Jul 2024 (estimated)
- Study completion
- 15 Aug 2024 (estimated)
- First posted
- 10 Apr 2024 (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 glycemic index is the ability of carbohydrates in foods to induce increases in blood glucose levels after consuming them. Based on the capacity for increasing blood glucose levels, foods can be classified as having a low, medium, or high glycemic index. This property is of interest in health and nutrition because it allows estimating the impact the food will have on postprandial glycemia, which may able better food selection in situations where adequate glycemic control is required, such as in individuals diagnosed with Diabetes Mellitus. The objective of this study is to determine the glycemic index of 9 formulations of complete oral nutrition supplements and classify them based on their glycemic response.
Detailed description
The determination of the glycemic index will be conducted following the protocol described in the International Standard Organization 26642. Specifically, the glycemic response of each food will be determined in 15 healthy volunteers, using a glucose-containing beverage with 25 g of glucose in 200 mL as a control for glycemic response measurement. The amount of food each volunteer will test will be equivalent to an intake of 25 g of digestible carbohydrates in a single intake. Subsequently, increases in blood glucose levels will be recorded at 15, 30, 45, 60, 90, and 120 minutes after initiating the food intake. Blood glucose measurements will be performed using a portable glucometer via capillary blood. The area under the curve of the increase in glucemia will be estimated using the trapezoidal method, and these will be compared with the glucose increases provided by the glucose-containing beverage.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Oral Nutritional Supplement 1 | Experimental | Dietary Supplement: Complete Oral Nutrition Supplement 1Oral Nutritional Supplement 1 |
| Oral Nutritional Supplement 2 | Experimental | Dietary Supplement: Complete Oral Nutrition Supplement 2Oral Nutritional Supplement 2 |
| Oral Nutritional Supplement 3 | Experimental | Dietary Supplement: Complete Oral Nutrition Supplement 3Oral Nutritional Supplement 3 |
| Oral Nutritional Supplement 4 | Experimental | Dietary Supplement: Complete Oral Nutrition Supplement 4Oral Nutritional Supplement 4 |
| Oral Nutritional Supplement 5 | Experimental | Dietary Supplement: Complete Oral Nutrition Supplement 5Oral Nutritional Supplement 5 |
| Oral Nutritional Supplement 6 | Experimental | Dietary Supplement: Complete Oral Nutrition Supplement 6Oral Nutritional Supplement 6 |
| Oral Nutritional Supplement 7 | Experimental | Dietary Supplement: Complete Oral Nutrition Supplement 7Oral Nutritional Supplement 7 |
| Oral Nutritional Supplement 8 | Experimental | Dietary Supplement: Complete Oral Nutrition Supplement 8Oral Nutritional Supplement 8 |
| Oral Nutritional Supplement 9 | Experimental | Dietary Supplement: Complete Oral Nutrition Supplement 9Oral Nutritional Supplement 9 |
| Glucose | Active comparator | Dietary Supplement: GlucoseGlucose solution |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy volunteers with no known food allergy or intolerance and pharmacological treatments known to affect glucose tolerance (excluding oral contraceptives)
Key exclusion criteria (6 listed)
- Known history of diabetes mellitus or the use of antihyperglycemic drugs or insulin to treat diabetes and related conditions.
- Any acute, chronic disease or any other serious complications that may interfere with glucose metabolism.
- Subjects using any medication (eg steroids, protease inhibitors or antipsychotics, etc.) that would interfere with the digestion and nutrient absorption.
- Subjects having gastrointestinal diseases that may interfere with nutrient absorption, distribution, metabolism, excretion
- A major medical or surgical event requiring hospitalization within the preceding 3 months.
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 |
|---|---|---|
| Complete Oral Nutrition Supplement 1Liquid formula produced by several food ingredients to provide a balance nutrient intake | Dietary supplement | Oral Nutritional Supplement 1 |
| Complete Oral Nutrition Supplement 2Liquid formula produced by several food ingredients to provide a balance nutrient intake | Dietary supplement | Oral Nutritional Supplement 2 |
| Complete Oral Nutrition Supplement 3Liquid formula produced by several food ingredients to provide a balance nutrient intake | Dietary supplement | Oral Nutritional Supplement 3 |
| Complete Oral Nutrition Supplement 4Liquid formula produced by several food ingredients to provide a balance nutrient intake | Dietary supplement | Oral Nutritional Supplement 4 |
| Complete Oral Nutrition Supplement 5Liquid formula produced by several food ingredients to provide a balance nutrient intake | Dietary supplement | Oral Nutritional Supplement 5 |
| Complete Oral Nutrition Supplement 6Liquid formula produced by several food ingredients to provide a balance nutrient intake | Dietary supplement | Oral Nutritional Supplement 6 |
| Complete Oral Nutrition Supplement 7Liquid formula produced by several food ingredients to provide a balance nutrient intake | Dietary supplement | Oral Nutritional Supplement 7 |
| Complete Oral Nutrition Supplement 8Liquid formula produced by several food ingredients to provide a balance nutrient intake | Dietary supplement | Oral Nutritional Supplement 8 |
| Complete Oral Nutrition Supplement 9Liquid formula produced by several food ingredients to provide a balance nutrient intake | Dietary supplement | Oral Nutritional Supplement 9 |
| Glucose25 mg of glucose dissolved in 200 mL | Dietary supplement | Glucose |
Primary outcome
Glycemic Index
Time frame: Post-prandial until 120 minutes after food intake
The area under the curve of glucose levels after the post-prandial intake of the oral nutrition supplement compared with the area under the curve of glucose levels after a post-prandial intake of a glucose solution
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complete Oral Nutrition Supplement 1, Complete Oral Nutrition Supplement 2 and Complete Oral Nutrition Supplement 3 in people with Glucose Metabolism Disorders, run by Universitat de Lleida 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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 10 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic Index (time frame: Post-prandial until 120 minutes after food intake). 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 10 Apr 2024.