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NCT05335863: TERATROFO
Glycemic Index Evaluation of a Hypercaloric/High-protein Nutritional Supplement in Healthy Adults
NA trial testing Oral Nutritional Supplement in Healthy in 12 participants. Completed in 9 February 2022.
23 December 2021
Quick facts
| Lead sponsor | Instituto de Investigación Hospital Universitario La Paz |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 12 |
| Start date | 3 November 2021 |
| Primary completion | 23 December 2021 |
| Estimated completion | 9 February 2022 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Oral Nutritional Supplement
- Glucose — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Instituto de Investigación Hospital Universitario La Paz
Who can join
Adults 18 to 65, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05335863
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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Trials by the same sponsor.
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- NCT06488898 — Abdominal Aortic Aneurysm Stabilization With Truncal Cells: Controlled Clinical Trial With Historical Cohorts · Phase 2 · recruiting
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- NCT06302647 — Assessing Interest in Web/App Platforms for Early Phase Clinical Trial Recruitment · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05335863 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Instituto de Investigación Hospital Universitario La Paz
- Last refreshed: 30 May 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05335863.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing