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AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Spain1 site
  • Institute for Health Research IdiPAZ

    Madrid, 28046

Other trials in Spain

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 groups in NCT05335863
Study groupRoleWhat they receive
ExperimentalExperimentalIngestion of FontActiv® DiaBest high protein/hypercaloric
Receives: Dietary Supplement: Oral Nutritional Supplement
ControlPlacebo comparatorIngestion 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.

  1. 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.

  1. First posted20 Apr 2022
  2. Study start3 Nov 2021
  3. Primary completion23 Dec 2021
  4. Study completion9 Feb 2022

Resources

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)
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

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.

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