PreDiabetesGLUCOCAPSNCT05560412
Zein Nanoparticles for Glycemic Control
A study testing Zein nanocapsules in people with PreDiabetes and Overweight and Obesity, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial summary
The use of zein nanoparticles as vehicles for drug delivery is under study, but of the effects observed in empty nanoparticles, in laboratory animals, the reduction of glucose levels was something worth studying. Thus, the present research on patients with prediabetes has been proposed. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes, Overweight and Obesity, Adult ALL
- What is being tested?
- Zein nanocapsules
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2023to 19 Dec 2023
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overweight or obesity (BMI between 25 and 40 kg/m2
- Presence of prediabetes (fasting glycemia in blood between 100 and 126 mg/dL)
- No weight variations considered relevant (+/- 5%) in the last 3 months
- Metformin treatment is allowed, as far as dose is stable (at least 2 months with unvaried dose).
- Good physical and psychological state.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Spain1 site
Centro de Investigacion en Nutricion. Universidad de Navarra
Pamplona, Navarre, 31008
About this study
The use of zein nanoparticles as vehicles for drug delivery is under study, but of the effects observed in empty nanoparticles, in laboratory animals, the reduction of glucose levels was something worth studying. Thus, the present research on patients with prediabetes has been proposed. The objective is to assess the efficacy of zein nanoparticles on the glycemic control. For this purpose, a randomized, double blind crossover study has been designed.
Target sample size is 60.
- Conditions
- PreDiabetes, Overweight and Obesity, Adult ALL
- Being tested
- Zein nanocapsules, control
- Keywords
- Prediabetes, Glycemia and glucose metabolism, Zein, Glucose monitoring
- Medical subject headings
- Prediabetic State, Overweight, Obesity, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zein nanocapsulesDietary supplement
1 g of Zein nanoencapsulated daily
controlDietary supplement
1 g of Zein non-encapsulated daily
| Study group | Role | What they receive |
|---|---|---|
| Zein nanocapsules | Experimental | Subjects will consume daily a powder dissolved in water with nanoencapsulated zein Receives: Dietary Supplement: Zein nanocapsules |
| control | Placebo comparator | Subjects will consume daily a powder dissolved in water with zein Receives: Dietary Supplement: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fructosamine
Change in the levels of Fructosamine From day 0 to day 28
Measured: 28 days
Change in GLP-1 AUC
Change in AUC of postprandial GLP-1 levels after OGTT
Measured: Baseline, 15, 30, 45 and 60 minutes
Secondary outcomes (3)
Fasting Plasma glucose
Change in Fasting Plasma glucose from day 0 to day 28
Measured: 28 days
Continuous glucose levels
Area under the curve of 28 days of plasma glucose levels
Measured: 28 days
Insulin Levels
Change in Fasting insulin levels from day 0 to day 28
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start10 Jan 2023
- Primary completion19 Dec 2023
- Study completion19 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomised, double blind crossover intervention
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560412
- Sponsor's protocol ID
- 2022.152
- Acronym
- GLUCOCAPS
- Status last verified
- Nov 2023
- First submitted
- 26 Sep 2022
- Last updated
- 31 Jan 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 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zein Nanoparticles for Glycemic Control
- ClinicalTrials.gov ID
- NCT05560412
- Acronym / sponsor ID
- GLUCOCAPS / 2022.152
- Conditions
- PreDiabetes, Overweight and Obesity, Adult ALL
- Keywords
- Prediabetes, Glycemia and glucose metabolism, Zein, Glucose monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 19 Dec 2023 (actual)
- Study completion
- 19 Dec 2023 (actual)
- First posted
- 29 Sep 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 use of zein nanoparticles as vehicles for drug delivery is under study, but of the effects observed in empty nanoparticles, in laboratory animals, the reduction of glucose levels was something worth studying. Thus, the present research on patients with prediabetes has been proposed. The objective is to assess the efficacy of zein nanoparticles on the glycemic control. For this purpose, a randomized, double blind crossover study has been designed.
Target sample size is 60.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised, double blind crossover intervention
| Arm | Type | Receives |
|---|---|---|
| Zein nanocapsules | Experimental | Dietary Supplement: Zein nanocapsulesSubjects will consume daily a powder dissolved in water with nanoencapsulated zein |
| control | Placebo comparator | Dietary Supplement: controlSubjects will consume daily a powder dissolved in water with zein |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Overweight or obesity (BMI between 25 and 40 kg/m2
- Presence of prediabetes (fasting glycemia in blood between 100 and 126 mg/dL)
- No weight variations considered relevant (+/- 5%) in the last 3 months
- Metformin treatment is allowed, as far as dose is stable (at least 2 months with unvaried dose).
- Good physical and psychological state.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Zein nanocapsules1 g of Zein nanoencapsulated daily | Dietary supplement | Zein nanocapsules |
| control1 g of Zein non-encapsulated daily | Dietary supplement | control |
Primary outcome
Change in Fructosamine
Time frame: 28 days
Change in the levels of Fructosamine From day 0 to day 28
Change in GLP-1 AUC
Time frame: Baseline, 15, 30, 45 and 60 minutes
Change in AUC of postprandial GLP-1 levels after OGTT
3 secondary outcomes
Fasting Plasma glucose
Time frame: 28 days
Continuous glucose levels
Time frame: 28 days
Insulin Levels
Time frame: 28 days
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 31 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zein nanocapsules in people with PreDiabetes and Overweight and Obesity, run by Clinica Universidad de Navarra, Universidad de Navarra 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 1 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 31 Jan 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. 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?
Change in Fructosamine (time frame: 28 days). The study lists 2 primary outcomes in all. 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 31 Jan 2024.