HealthyTERATROFONCT05335863
Glycemic Index Evaluation of a Hypercaloric/High-protein Nutritional Supplement in Healthy Adults
A study testing Oral Nutritional Supplement and Glucose in people with Healthy, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial summary
Diabetes mellitus (DM) is a chronic disease with a higher prevalence in the world population, especially in the elderly population.The main consequence of the alteration of DM is the increase in blood glucose levels. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Oral Nutritional Supplement and Glucose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- 3 Nov 2021to 9 Feb 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women between 18 and 65 years
- Patients without chronic uncontrolled diseases
- Patients willing to consume the Oral Nutritional Supplement (ONS) to carry out the study
- Patients with adequate cultural level and understanding of the clinical study
- Patients who agree to voluntarily participate in the study and who give their informed consent in writing
Who cannot join
- Subjects with any serious chronic pathology.
- Subjects with metabolic or intestinal pathologies that interfere with the homeostatic mechanisms of glucose
- Subjects with neurological pathologies or eating disorders that interfere with acute tests.
- Subjects with allergies or intolerances to any of the ingredients in the formula
- Subjects with socio-family problems that prevent them from participating in the study
- Subjects with intense physical activity
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial to Evaluate Hypercaloric/High-protein Nutritional Supplement Glycemic Index Enriched With Calcium, Vitamin D and Docosahexaenoic Acid (DHA) in Healthy Adults
Diabetes mellitus (DM) is a chronic disease with a higher prevalence in the world population, especially in the elderly population.The main consequence of the alteration of DM is the increase in blood glucose levels. When the concentration reaches levels above 180-200 mg / dl after ingestion, the following symptoms appear: polyphagia, polydipsia, polyuria and weight loss. Diet, on some occasions, is the only therapy necessary. The commercialized formulas considered as "standard", have a high content of carbohydrates with a high glycemic index (approximately 50%) and low in lipids (30-35%) and do not usually contain fiber. This type of liquid formulations seem to increase the insulin and glycemic response in healthy people, and to a greater extent in patients with DM, compared to what would cause a similar intake of nutrients in a mixed diet.
All diabetic formulas provide carbohydrates with low glycemic index. They are made from starches, with a variable contribution of fructose, which in all cases should be less than 20% of the total caloric intake, due to its lower glycemic index, its greater sweetening power and its entry into the cell is insulin-independent. However, it is necessary to determine the glycemic index of the new specific formulas for this population through clinical trials.Based on these initial facts, researchers consider it appropriate to carry out a pilot study to evaluate the glycemic index of a Oral Nutritional Supplement (ONS) especially indicated for diabetic people in a group of healthy people.
Read the detailed description
Diabetes mellitus (DM) is a chronic disease with a higher prevalence in the world population, especially in the elderly population. It is considered one of the main health problems worldwide. Taking into account the aging of the population, the increase in obesity and the sedentary lifestyle, the World Health Organization (WHO) predicts that disease incidence in developed countries will increase. In Spain, DM affects 6% of the population; being more frequent type 2 DM in the elderly population. Nearby 20% of the Spanish population> 60 years of age suffers from it. In type 2 DM there is resistance to insulin, in addition to a deficit in its production. Concerning hyperglycemia, both phenomena must be present.
The main consequence of the alteration of DM is the increase in blood glucose levels. When the concentration reaches levels above 180-200 mg / dL after ingestion, the following symptoms appear: polyphagia, polydipsia, polyuria and weight loss. These short-term symptoms are the most common. Diabetes prevention is based on an integrated holistic approach based on healthy eating, daily physical exercise and adequate health education. To achieve a proper balance between these three pillars, patient collaboration is required.
Most of cases just need diet as the only therapy needed. The importance of weight loss is highlighted, since approximately 80% of patients with DM 2 have a BMI> 25 kg / m2. The main objective of the diet is to achieve normal blood glucose levels both in the fasting state and in the postprandial phase. Blood pressure and lipid control are also important. However, elderly diabetic patients are more likely to suffer from malnutrition associated with the disease, with a higher prevalence than in the general population. The prevalence of the diabetic patient referring to the hospital setting ranges between 5-11%. However, extracted data from hospital discharges rise up to 20%, if medical records are considered.
The main indications for enteral nutrition (EN) application, according to data from 2001, were neurological alterations (43.3%) and neoplasms (39%), which are frequent pathologies in elderly patients. Regarding hospitalized patients, between 5-10% receive some type of nutritional support. When prevalence rate of diabetic patients is applied to this population group, 1-2% of hospitalized diabetic patients are prescribed with some type of nutritional supplement. Malnutrition in diabetic patients worsens if the supplements are not correctly tolerated, leading to a worse diagnosis due to the difficulty in healing and the greater propensity for infections, leading to longer hospital stays.
The commercialized formulas considered as "standard", have a high content of carbohydrates with a high glycemic index (approximately 50%) and low lipids (30-35%) and do not usually contain fiber. This type of liquid formulations seems to increase the insulin and glycemic response in healthy people, and to a greater extent in patients with DM, compared to what would cause a similar intake of nutrients in a mixed diet. It seems that when ingesting a formula with a low carbohydrate content and high content of monounsaturated fatty acids, the postprandial glycemic response depends fundamentally on the total carbohydrate content, downplaying the source (starch or fructose) or even the addition or type of fiber. Therefore, it seems that as the carbohydrate content increases, the lipid content could contribute to the attenuation of the glycemic response. However, more comparisons are needed between specific diabetes diets (high, moderate, and low fat) with each other and with other standard diets (with and without fiber).
All diabetic formulas provide carbohydrates with low glycemic index. They are made from starches, with a variable contribution of fructose. Fructose should be less than 20% of the total caloric intake in all cases, due to its lower glycemic index, its greater sweetening power and its entry into the cell as insulin-independent. However, it is necessary to determine the glycemic index of the new specific formulas for this population through clinical trials.
Based on these initial facts, researchers consider to carry out a pilot study to evaluate the glycemic index of a Oral Nutritional Supplement (ONS) especially indicated for diabetic patients in a group of healthy people.
- Conditions
- Healthy
- Being tested
- Oral Nutritional Supplement, Glucose
- Keywords
- diabetes, oral nutritional supplement, glycemic index, healthy population
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Nutritional SupplementDietary supplement
Also called Experimental
Participants must consume 416 mL of ONS FontActiv® DiaBest HP / HC vanilla flavor. A maximum time of 10 min will be given to consume the entire product.
GlucoseDietary supplement
Participants must consume a 50 g glucose solution in 10 min to obtain the ares under the curve (AUC) data from glucose consumption
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Ingestion of FontActiv® DiaBest high protein/hypercaloric Receives: Dietary Supplement: Oral Nutritional Supplement |
| Control | Placebo comparator | Ingestion of glucose standard solution Receives: Dietary Supplement: Glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Areas under the glucose metabolism curve for the determination of the glycemic index
Statistical calculation of the area under the curve at different times of blood collection (baseline, 0, 30, 60, 90 and 120 minutes)
Measured: 0-120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start3 Nov 2021
- Primary completion23 Dec 2021
- Study completion9 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossed, controlled and randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacio Eurecat
- Responsible party
- Sponsor
- Investigators
- Bricia López-Plaza, MsC, PhD, Principal investigator, Instituto de Investigación Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335863
- Sponsor's protocol ID
- HULP 5921
- Acronym
- TERATROFO
- Status last verified
- Feb 2022
- First submitted
- 18 Jul 2021
- Last updated
- 30 May 2023
- 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 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate Hypercaloric/High-protein Nutritional Supplement Glycemic Index Enriched With Calcium, Vitamin D and Docosahexaenoic Acid (DHA) in Healthy Adults
- ClinicalTrials.gov ID
- NCT05335863
- Acronym / sponsor ID
- TERATROFO / HULP 5921
- Conditions
- Healthy
- Keywords
- diabetes, oral nutritional supplement, glycemic index, healthy population
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Collaborators
- Fundacio Eurecat
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 23 Dec 2021 (actual)
- Study completion
- 9 Feb 2022 (actual)
- First posted
- 20 Apr 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.
Diabetes mellitus (DM) is a chronic disease with a higher prevalence in the world population, especially in the elderly population.The main consequence of the alteration of DM is the increase in blood glucose levels. When the concentration reaches levels above 180-200 mg / dl after ingestion, the following symptoms appear: polyphagia, polydipsia, polyuria and weight loss. Diet, on some occasions, is the only therapy necessary. The commercialized formulas considered as "standard", have a high content of carbohydrates with a high glycemic index (approximately 50%) and low in lipids (30-35%) and do not usually contain fiber. This type of liquid formulations seem to increase the insulin and glycemic response in healthy people, and to a greater extent in patients with DM, compared to what would cause a similar intake of nutrients in a mixed diet.
All diabetic formulas provide carbohydrates with low glycemic index. They are made from starches, with a variable contribution of fructose, which in all cases should be less than 20% of the total caloric intake, due to its lower glycemic index, its greater sweetening power and its entry into the cell is insulin-independent. However, it is necessary to determine the glycemic index of the new specific formulas for this population through clinical trials.Based on these initial facts, researchers consider it appropriate to carry out a pilot study to evaluate the glycemic index of a Oral Nutritional Supplement (ONS) especially indicated for diabetic people in a group of healthy people.
Detailed description
Diabetes mellitus (DM) is a chronic disease with a higher prevalence in the world population, especially in the elderly population. It is considered one of the main health problems worldwide. Taking into account the aging of the population, the increase in obesity and the sedentary lifestyle, the World Health Organization (WHO) predicts that disease incidence in developed countries will increase. In Spain, DM affects 6% of the population; being more frequent type 2 DM in the elderly population. Nearby 20% of the Spanish population> 60 years of age suffers from it. In type 2 DM there is resistance to insulin, in addition to a deficit in its production. Concerning hyperglycemia, both phenomena must be present.
The main consequence of the alteration of DM is the increase in blood glucose levels. When the concentration reaches levels above 180-200 mg / dL after ingestion, the following symptoms appear: polyphagia, polydipsia, polyuria and weight loss. These short-term symptoms are the most common. Diabetes prevention is based on an integrated holistic approach based on healthy eating, daily physical exercise and adequate health education. To achieve a proper balance between these three pillars, patient collaboration is required.
Most of cases just need diet as the only therapy needed. The importance of weight loss is highlighted, since approximately 80% of patients with DM 2 have a BMI> 25 kg / m2. The main objective of the diet is to achieve normal blood glucose levels both in the fasting state and in the postprandial phase. Blood pressure and lipid control are also important. However, elderly diabetic patients are more likely to suffer from malnutrition associated with the disease, with a higher prevalence than in the general population. The prevalence of the diabetic patient referring to the hospital setting ranges between 5-11%. However, extracted data from hospital discharges rise up to 20%, if medical records are considered.
The main indications for enteral nutrition (EN) application, according to data from 2001, were neurological alterations (43.3%) and neoplasms (39%), which are frequent pathologies in elderly patients. Regarding hospitalized patients, between 5-10% receive some type of nutritional support. When prevalence rate of diabetic patients is applied to this population group, 1-2% of hospitalized diabetic patients are prescribed with some type of nutritional supplement. Malnutrition in diabetic patients worsens if the supplements are not correctly tolerated, leading to a worse diagnosis due to the difficulty in healing and the greater propensity for infections, leading to longer hospital stays.
The commercialized formulas considered as "standard", have a high content of carbohydrates with a high glycemic index (approximately 50%) and low lipids (30-35%) and do not usually contain fiber. This type of liquid formulations seems to increase the insulin and glycemic response in healthy people, and to a greater extent in patients with DM, compared to what would cause a similar intake of nutrients in a mixed diet. It seems that when ingesting a formula with a low carbohydrate content and high content of monounsaturated fatty acids, the postprandial glycemic response depends fundamentally on the total carbohydrate content, downplaying the source (starch or fructose) or even the addition or type of fiber. Therefore, it seems that as the carbohydrate content increases, the lipid content could contribute to the attenuation of the glycemic response. However, more comparisons are needed between specific diabetes diets (high, moderate, and low fat) with each other and with other standard diets (with and without fiber).
All diabetic formulas provide carbohydrates with low glycemic index. They are made from starches, with a variable contribution of fructose. Fructose should be less than 20% of the total caloric intake in all cases, due to its lower glycemic index, its greater sweetening power and its entry into the cell as insulin-independent. However, it is necessary to determine the glycemic index of the new specific formulas for this population through clinical trials.
Based on these initial facts, researchers consider to carry out a pilot study to evaluate the glycemic index of a Oral Nutritional Supplement (ONS) especially indicated for diabetic patients in a group of healthy people.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Crossed, controlled and randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Dietary Supplement: Oral Nutritional SupplementIngestion of FontActiv® DiaBest high protein/hypercaloric |
| Control | Placebo comparator | Dietary Supplement: GlucoseIngestion of glucose standard solution |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women between 18 and 65 years
- Patients without chronic uncontrolled diseases
- Patients willing to consume the Oral Nutritional Supplement (ONS) to carry out the study
- Patients with adequate cultural level and understanding of the clinical study
- Patients who agree to voluntarily participate in the study and who give their informed consent in writing
Key exclusion criteria (7 listed)
- Subjects with any serious chronic pathology.
- Subjects with metabolic or intestinal pathologies that interfere with the homeostatic mechanisms of glucose
- Subjects with neurological pathologies or eating disorders that interfere with acute tests.
- Subjects with allergies or intolerances to any of the ingredients in the formula
- Subjects with socio-family problems that prevent them from participating in 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 |
|---|---|---|
| Oral Nutritional SupplementAlso: ExperimentalParticipants must consume 416 mL of ONS FontActiv® DiaBest HP / HC vanilla flavor. A maximum time of 10 min will be given to consume the entire product. | Dietary supplement | Experimental |
| GlucoseParticipants must consume a 50 g glucose solution in 10 min to obtain the ares under the curve (AUC) data from glucose consumption | Dietary supplement | Control |
Primary outcome
Areas under the glucose metabolism curve for the determination of the glycemic index
Time frame: 0-120 minutes
Statistical calculation of the area under the curve at different times of blood collection (baseline, 0, 30, 60, 90 and 120 minutes)
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 30 May 2023.
- 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.
Bricia López-Plaza, MsC, PhD principal investigator
Instituto de Investigación Hospital Universitario La Paz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Nutritional Supplement and Glucose in people with Healthy, run by Instituto de Investigación Hospital Universitario La Paz 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 5 inclusion and 7 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 30 May 2023. 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. Some participants in this study may receive a placebo. 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?
Areas under the glucose metabolism curve for the determination of the glycemic index (time frame: 0-120 minutes). 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 30 May 2023.