Type 2 Diabetes MellitusOPODIABENCT06723886
Antidiabetic Effect of Olive Pomace Oil
A study testing Experimental arm: Olive pomace oil and High-oleic acid sunflower oil in people with Type 2 Diabetes Mellitus and Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), run by Instituto de Ciencia y Tecnología de Alimentos y Nutrición at 1 site in Spain.
Trial summary
This clinical trial aims at assessing whether consumption of olive pomace oil in the diet may benefit persons with type 2 diabetes mellitus or persons at risk of developing the disease (prediabetic persons). Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Prediabetic State
- What is being tested?
- Experimental arm: Olive pomace oil and High-oleic acid sunflower oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fasting blood glucose between 100-126 mg/dL and/or
- Glycated haemoglobin (HbA1c) between 5.7-6.4% and/or
- Diabetic persons with Fasting blood glucose >126 mg/dL and/or
- Diabetic persons with Glycated haemoglobin (HbA1c) > 6.4%
Who cannot join
- Kidney or liver diseases
- Gastrointestinal diseases (irritable bowel syndrome, Crohn disease, chronic bowel inflammation)
- Food allergies/intolerances
- Vegetarians/vegans
- Smoking
- Pregnant or lactating women
- On prescription drugs other than for hypertension/thyroid/dyslipidemia/glucose control, or changes in dosage in the last 3 months
- Consumption of vitamins, dietary supplements or nutraceuticals
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Institute of Food Science, Technology and Nutrition (ICTAN-CSIC)
Madrid, Madrid, 28040
Laura Bravo, Professor, +34 91 5492300 ext. 436350, lbravo@ictan.csic.es
Beatriz Sarria, Dr, +34 91 5492300 ext. 436342, beasarria@ictan.csic.es
About this study
Official title: Assessment of the Potential Antidiabetic Effects of Olive Pomace Oil in Diabetic or Prediabetic Subjects: Postprandial Study and Chronic Intervention
This clinical trial aims at assessing whether consumption of olive pomace oil in the diet may benefit persons with type 2 diabetes mellitus or persons at risk of developing the disease (prediabetic persons).
The main questions the study aims to answer are:
Read more
- May olive pomace oil prevent a high increase of blood glucose levels when consumed in a meal together with carbohydrates in diabetic/prediabetic patients?
- May olive pomace oil decrease fasting blood glucose levels of diabetic/prediabetic patients after consuming it daily?
- May daily consumption of olive pomace oil improve glucose homeostasis and other alterations like elevated blood lipids or inflammation, which also affect persons with diabetes or prediabetes?
Researchers will compare the effect of consuming olive pomace oil to the effects of a comparison oil (high-oleic acid sunflower oil).
Participants will:
In different days, they will consume white bread alone or the oils (olive pomace oil, high-oleic acid sunflower oil or extra virgin olive oil) spread on white bread and blood will be collected at different times during 2 h. This study to observe the increase of blood glucose after a carbohydrate-rich breakfast will be part of the so-called "postprandial" study, and will be conducted during 3 weeks, during which participants will consume corn oil on a daily basis.
Participants will also take part in the "chronic" study, that will last 22 weeks in total. During this study, they will firstly "wash" the effects of the oil they normally consume in their diets by consuming corn oil during 3 weeks. It is during these weeks when they will attend the Human Nutrition Unit (HNU) of ICTAN to carry on the "postprandial" study described in the previous paragraph.
After the initial 3 weeks, participants will consume olive pomace oil as the only oil in their diets during 8 weeks, "wash" its effects again by consuming corn oil during 3 weeks and then change to consume the other oil (high-oleic acid sunflower oil) during 8 weeks.
During the chronic study, they will visit the clinic once every 4 weeks for checkups and tests. They will refrain from eating other oils or specific fat-rich foods. Participants will also attend our phone calls to ask them what they ate the day before on different weeks during the study, and wear an accelerometer during 1 week to record their physical activity. They will keep a diary of the doses of insulin/metformin used and the blood glucose levels they measured at home.
Read the detailed description
This trial comprises 2 studies in parallel, a postprandial study and a chronic intervention.
In the postprandial study, participants will attend the Human Nutrition Unit (HNU) of ICTAN in different days. During these visits, they will consume white bread (50 g) alone or with 10 g of extra virgin olive oil (EVOO), olive pomace oil (OPO) or high-oleic acid sunflower oil (HOSO). A nurse will insert a catheter in the non-prevailing arm and collect fasting blood (0 h) and blood samples 1 and 2 h after consuming the bread/oil to measure the postprandial glycemic/insulinemic response, as well as incretins (GLP-1, GIP). Blood lipids will also be determined. These visits will be carried out during the 3-week run-in period prior to the chronic intervention, when the EVOO and control (white bread) tests will be carried out (weeks 1 and 2, respectively). Then, coinciding with the first day of the chronic intervention, participants will consume either OPO or HOSO as corresponding to the randomized allocation to each oil. The other postprandial test will be carried out at the beginning of the second intervention after crossover and wash-out, thus avoiding additional visits and discomfort to the participants.
The chronic study is a crossover, randomized, blind, clinical trial. After a 3-week run-in during which participants will consume corn oil as the only dietary oil, they will be randomly allocated to one of each intervention arms, OPO or HOSO, each lasting 8 weeks. Then, a 3-week wash-out period with corn oil will follow before changing to consuming the other oil.
During the study, participants should avoid other oils and fats such as olives, sunflower seeds, butter, margarine, nuts or avocados.
During the chronic intervention, participants will visit the HNU at the beginning (week 1), middle (week 4) and at the end (week 8) of each intervention arm. A nurse will collect a fasting blood sample and measure blood pressure. An analysis of body weight and body composition (anthropometric and bioimpedance measurements) will be performed. Participants should maintain their habitual diet and exercise level throughout the study; diet will be monitored by periodic 24-h recall questionnaires (a trained member of the team will phone participants on 3 different days (including a festive one) before each visit to the HNU to enquire what they ate the previous day). In addition, a physical activity questionnaire will be completed at the beginning of the study and, on each intervention arm, participants will carry during 7 days an accelerometer to monitor real physical activity.
Biochemical, hormonal and inflammatory markers will be measured in blood samples to assess the potential effect of olive pomace oil on different outcomes of relevance in the management of blood glucose in diabetic/prediabetic persons, including glucose homeostasis, insulin resistance, blood lipid levels, liver function, different hormones, incretins, adipokines, pro- and anti-inflammatory cytokines, on integrity of the intestinal barrier.
- Conditions
- Type 2 Diabetes Mellitus, Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Prediabetic State, Diabetes, Diabetes Mellitus
- Being tested
- Experimental arm: Olive pomace oil, High-oleic acid sunflower oil
- Keywords
- Olive pomace oil, Diabetes, Prediabetes, Antidiabetic effect, Postprandial study, Chronic intervention, High-oleic acid sunflower oil
- Medical subject headings
- Diabetes Mellitus, Type 2, Prediabetic State, Insulin Resistance, Glucose Intolerance, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental arm: Olive pomace oilDietary supplement
Participants will consume during 8 weeks either the test oil (olive pomace oil) as the only dietary fat. They will consume 45 g/day of oil, using it in salads, fried foods, as spread on toasts, etc.
High-oleic acid sunflower oilDietary supplement
Participants will consume during 8 weeks either the test active comparator oil (high-oleic acid sunflower oil) as the only dietary fat. They will consume 45 g/day of oil, using it in salads, fried foods, as spread on toasts, etc.
| Study group | Role | What they receive |
|---|---|---|
| Olive pomace oil | Experimental | Consumption of olive pomace oil as the only dietary fat. Receives: Dietary Supplement: Experimental arm: Olive pomace oil |
| High-sunflower olive oil | Active comparator | Consumption of high-oleic acid sunflower oil as the only dietary fat. Receives: Dietary Supplement: High-oleic acid sunflower oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting blood glucose
Change of fasting blood glucose levels at the end of the chronic intervention
Measured: From enrollment to the end of each treatment at 8 weeks
Postprandial blood glucose response
Change of postprandial blood glucose levels after consuming white bread with oil in comparison with white bread only.
Blood will be collected at 0 h and 1 and 2 h after consuming the bread alone or with the corresponding oil. Olive pomace oil (active comparator) and high-oleic acid sunflower oil (active comparator) will be tested. Only in this postprandial study extra virgin olive oil will also be tested as a positive control (at the beginning of the run-in), along with white bread only (at week 2 of the run-in). Test/comparator oils will be assessed at the beginning of each arm, week 1 of each intervention arm (corresponding to weeks 4 and 14 of the study).
Measured: From enrollment until week 14 of the study
Secondary outcomes (8)
Insulin levels
Change in fasting blood insulin levels at the end of the chronic intervention
Measured: From enrollment to the end of each treatment at 8 weeks
Insulin resistance
Change in homeostasis model assessment (HOMA) of insulin resistance (HOMA-IR) at the end of the chronic intervention
Measured: From enrollment to the end of each treatment at 8 weeks
Insulin sensitivity
Change in quantitative insulin levels sensitivity check index (QUICKI) at the end of the chronic intervention. Higher score in QUICKI means a better outcome compared to initial values.
Measured: From enrollment to the end of each treatment at 8 weeks
Glycated hemoglobin
Change in blood levels of glycated hemoglobin (HbA1c) at the end of the chronic intervention
Measured: From enrollment to the end of each treatment at 8 weeks
Beta-cell function
Change in homeostasis model assessment (HOMA) of beta-cell function (HOMA-B) at the end of the chronic intervention
Measured: From enrollment to the end of each treatment at 8 weeks
Postprandial insulin response
Change of postprandial blood insulin levels after consuming white bread with oil in comparison with white bread only.
Blood will be collected at 0 h and 1 and 2 h after consuming the bread alone or with the corresponding oil. Olive pomace oil (active comparator) and high-oleic acid sunflower oil (active comparator) will be tested. Only in this postprandial study extra virgin olive oil will also be tested as a positive control (at the beginning of the run-in), along with white bread only (at week 2 of the run-in). Test/comparator oils will be assessed at the beginning of each arm, week 1 of each intervention arm (corresponding to weeks 4 and 14 of the study).
Measured: From enrollment to week 14 of the study
Postprandial incretins
Change of postprandial levels of GLP-1 and GIP after consuming white bread with oil in comparison with white bread only.
Blood will be collected at 0 h and 1 and 2 h after consuming the bread alone or with the corresponding oil. Olive pomace oil (active comparator) and high-oleic acid sunflower oil (active comparator) will be tested. Only in this postprandial study extra virgin olive oil will also be tested as a positive control (at the beginning of the run-in), along with white bread only (at week 2 of the run-in). Test/comparator oils will be assessed at the beginning of each arm, week 1 of each intervention arm (corresponding to weeks 4 and 14 of the study).
Measured: From enrollment to week 14 of the study
Postprandial blood lipids
Change of postprandial blood lipid levels after consuming white bread with oil in comparison with white bread only.
Blood will be collected at 0 h and 1 and 2 h after consuming the bread alone or with the corresponding oil. Olive pomace oil (active comparator) and high-oleic acid sunflower oil (active comparator) will be tested. Only in this postprandial study extra virgin olive oil will also be tested as a positive control (at the beginning of the run-in), along with white bread only (at week 2 of the run-in). Test/comparator oils will be assessed at the beginning of each arm, week 1 of each intervention arm (corresponding to weeks 4 and 14 of the study).
Measured: From enrollment to week 14 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start15 Jan 2025 (estimated)
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Crossover, controlled, randomized, blind study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Ciencia y Tecnología de Alimentos y Nutrición
- Sponsor type
- Other government
- Collaborators
- ICTAN-CSIC - Madrid - Spain
- Responsible party
- Sponsor
- Investigators
- Laura Bravo, Professor, Principal investigator, ICTAN-CSIC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723886
- Sponsor's protocol ID
- 20232949
- Other IDs
- 253405
- Acronym
- OPODIABE
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Interesting researchers may contact the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Potential Antidiabetic Effects of Olive Pomace Oil in Diabetic or Prediabetic Subjects: Postprandial Study and Chronic Intervention
- ClinicalTrials.gov ID
- NCT06723886
- Acronym / sponsor ID
- OPODIABE / 20232949
- Conditions
- Type 2 Diabetes Mellitus, Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Prediabetic State, Diabetes, Diabetes Mellitus
- Keywords
- Olive pomace oil, Diabetes, Prediabetes, Antidiabetic effect, Postprandial study, Chronic intervention, High-oleic acid sunflower oil
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Instituto de Ciencia y Tecnología de Alimentos y NutriciónOther government
- Collaborators
- ICTAN-CSIC - Madrid - Spain
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 9 Dec 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.
This clinical trial aims at assessing whether consumption of olive pomace oil in the diet may benefit persons with type 2 diabetes mellitus or persons at risk of developing the disease (prediabetic persons).
The main questions the study aims to answer are:
- May olive pomace oil prevent a high increase of blood glucose levels when consumed in a meal together with carbohydrates in diabetic/prediabetic patients?
- May olive pomace oil decrease fasting blood glucose levels of diabetic/prediabetic patients after consuming it daily?
- May daily consumption of olive pomace oil improve glucose homeostasis and other alterations like elevated blood lipids or inflammation, which also affect persons with diabetes or prediabetes?
Researchers will compare the effect of consuming olive pomace oil to the effects of a comparison oil (high-oleic acid sunflower oil).
Participants will:
In different days, they will consume white bread alone or the oils (olive pomace oil, high-oleic acid sunflower oil or extra virgin olive oil) spread on white bread and blood will be collected at different times during 2 h. This study to observe the increase of blood glucose after a carbohydrate-rich breakfast will be part of the so-called "postprandial" study, and will be conducted during 3 weeks, during which participants will consume corn oil on a daily basis.
Participants will also take part in the "chronic" study, that will last 22 weeks in total. During this study, they will firstly "wash" the effects of the oil they normally consume in their diets by consuming corn oil during 3 weeks. It is during these weeks when they will attend the Human Nutrition Unit (HNU) of ICTAN to carry on the "postprandial" study described in the previous paragraph.
After the initial 3 weeks, participants will consume olive pomace oil as the only oil in their diets during 8 weeks, "wash" its effects again by consuming corn oil during 3 weeks and then change to consume the other oil (high-oleic acid sunflower oil) during 8 weeks.
During the chronic study, they will visit the clinic once every 4 weeks for checkups and tests. They will refrain from eating other oils or specific fat-rich foods. Participants will also attend our phone calls to ask them what they ate the day before on different weeks during the study, and wear an accelerometer during 1 week to record their physical activity. They will keep a diary of the doses of insulin/metformin used and the blood glucose levels they measured at home.
Detailed description
This trial comprises 2 studies in parallel, a postprandial study and a chronic intervention.
In the postprandial study, participants will attend the Human Nutrition Unit (HNU) of ICTAN in different days. During these visits, they will consume white bread (50 g) alone or with 10 g of extra virgin olive oil (EVOO), olive pomace oil (OPO) or high-oleic acid sunflower oil (HOSO). A nurse will insert a catheter in the non-prevailing arm and collect fasting blood (0 h) and blood samples 1 and 2 h after consuming the bread/oil to measure the postprandial glycemic/insulinemic response, as well as incretins (GLP-1, GIP). Blood lipids will also be determined. These visits will be carried out during the 3-week run-in period prior to the chronic intervention, when the EVOO and control (white bread) tests will be carried out (weeks 1 and 2, respectively). Then, coinciding with the first day of the chronic intervention, participants will consume either OPO or HOSO as corresponding to the randomized allocation to each oil. The other postprandial test will be carried out at the beginning of the second intervention after crossover and wash-out, thus avoiding additional visits and discomfort to the participants.
The chronic study is a crossover, randomized, blind, clinical trial. After a 3-week run-in during which participants will consume corn oil as the only dietary oil, they will be randomly allocated to one of each intervention arms, OPO or HOSO, each lasting 8 weeks. Then, a 3-week wash-out period with corn oil will follow before changing to consuming the other oil.
During the study, participants should avoid other oils and fats such as olives, sunflower seeds, butter, margarine, nuts or avocados.
During the chronic intervention, participants will visit the HNU at the beginning (week 1), middle (week 4) and at the end (week 8) of each intervention arm. A nurse will collect a fasting blood sample and measure blood pressure. An analysis of body weight and body composition (anthropometric and bioimpedance measurements) will be performed. Participants should maintain their habitual diet and exercise level throughout the study; diet will be monitored by periodic 24-h recall questionnaires (a trained member of the team will phone participants on 3 different days (including a festive one) before each visit to the HNU to enquire what they ate the previous day). In addition, a physical activity questionnaire will be completed at the beginning of the study and, on each intervention arm, participants will carry during 7 days an accelerometer to monitor real physical activity.
Biochemical, hormonal and inflammatory markers will be measured in blood samples to assess the potential effect of olive pomace oil on different outcomes of relevance in the management of blood glucose in diabetic/prediabetic persons, including glucose homeostasis, insulin resistance, blood lipid levels, liver function, different hormones, incretins, adipokines, pro- and anti-inflammatory cytokines, on integrity of the intestinal barrier.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Crossover, controlled, randomized, blind study
| Arm | Type | Receives |
|---|---|---|
| Olive pomace oil | Experimental | Dietary Supplement: Experimental arm: Olive pomace oilConsumption of olive pomace oil as the only dietary fat. |
| High-sunflower olive oil | Active comparator | Dietary Supplement: High-oleic acid sunflower oilConsumption of high-oleic acid sunflower oil as the only dietary fat. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Fasting blood glucose between 100-126 mg/dL and/or
- Glycated haemoglobin (HbA1c) between 5.7-6.4% and/or
- Diabetic persons with Fasting blood glucose >126 mg/dL and/or
- Diabetic persons with Glycated haemoglobin (HbA1c) > 6.4%
Key exclusion criteria (8 listed)
- Kidney or liver diseases
- Gastrointestinal diseases (irritable bowel syndrome, Crohn disease, chronic bowel inflammation)
- Food allergies/intolerances
- Vegetarians/vegans
- Smoking
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 |
|---|---|---|
| Experimental arm: Olive pomace oilParticipants will consume during 8 weeks either the test oil (olive pomace oil) as the only dietary fat. They will consume 45 g/day of oil, using it in salads, fried foods, as spread on toasts, etc. | Dietary supplement | Olive pomace oil |
| High-oleic acid sunflower oilParticipants will consume during 8 weeks either the test active comparator oil (high-oleic acid sunflower oil) as the only dietary fat. They will consume 45 g/day of oil, using it in salads, fried foods, as spread on toasts, etc. | Dietary supplement | High-sunflower olive oil |
Primary outcome
Fasting blood glucose
Time frame: From enrollment to the end of each treatment at 8 weeks
Change of fasting blood glucose levels at the end of the chronic intervention
Postprandial blood glucose response
Time frame: From enrollment until week 14 of the study
Change of postprandial blood glucose levels after consuming white bread with oil in comparison with white bread only. Blood will be collected at 0 h and 1 and 2 h after consuming the bread alone or with the corresponding oil. Olive pomace oil (active comparator) and high-oleic acid sunflower oil (active comparator) will be tested. Only in this postprandial study extra virgin olive oil will also be tested as a positive control (at the beginning of the run-in), along with white bread only (at week 2 of the run-in). Test/comparator oils will be assessed at the beginning of each arm, week 1 of each intervention arm (corresponding to weeks 4 and 14 of the study).
8 secondary outcomes
Insulin levels
Time frame: From enrollment to the end of each treatment at 8 weeks
Insulin resistance
Time frame: From enrollment to the end of each treatment at 8 weeks
Insulin sensitivity
Time frame: From enrollment to the end of each treatment at 8 weeks
Glycated hemoglobin
Time frame: From enrollment to the end of each treatment at 8 weeks
Beta-cell function
Time frame: From enrollment to the end of each treatment at 8 weeks
Postprandial insulin response
Time frame: From enrollment to week 14 of the study
Postprandial incretins
Time frame: From enrollment to week 14 of the study
Postprandial blood lipids
Time frame: From enrollment to week 14 of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: Yes. Interesting researchers may contact the principal investigator
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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.
Laura Bravo, Professor principal investigator
ICTAN-CSIC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental arm: Olive pomace oil and High-oleic acid sunflower oil in people with Type 2 Diabetes Mellitus and Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), run by Instituto de Ciencia y Tecnología de Alimentos y Nutrición 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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 11 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Bravo, Professor (+34 91 5492300 ext. 436350, lbravo@ictan.csic.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting blood glucose (time frame: From enrollment to the end of each treatment at 8 weeks). 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 11 Dec 2024; AzTrials last refreshed its copy on 6 Nov 2026.