OverweightHT15NCT06295913
Hydroxytyrosol Dietary Supplement and Prevention of Age-Related Diseases
A study testing Group 1, hydroxytyrosol-rich extract capsule in people with Overweight and PreDiabetes, run by National Research Council, Spain at 1 site in Spain.
Trial summary
The primary objective of this study is to ascertain the effects of chronic consumption of a hydroxytyrosol-rich extract from olive in a population at high risk of developing age-related pathologies such as type 2 diabetes and cardiovascular diseases. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, PreDiabetes
- What is being tested?
- Group 1, hydroxytyrosol-rich extract capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2023to 20 Dec 2024
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Prediabetes (defined as fasting glucose levels according to the American Diabetes Association guideline, with fasting blood glucose ≥100 and <126 mg/dL, or hemoglobin A1c levels ranging from 5.7% to 6.4%)
- Overweight (body mass index BMI 24-29.9 kg/m2)
Who cannot join
- Any prior diagnosis of diabetes, hypertension, hyperlipidemia, other cardiovascular diseases, thyroid gland disorders, asthma, arthritis, or inflammatory conditions, cirrhosis, or other liver diseases
- Weight loss > 2.5 kg in the last 6 months
- Being on pharmacological treatment of any kind
- Taking dietary supplements containing antioxidants other than vitamins
- Being a smoker or habitual alcohol consumer; being HIV positive
- Being pregnant or breastfeeding
- Blood pressure ≥ 140 mmHg (systolic) and ≥ 90 mmHg (diastolic)
- Total cholesterol ≥ 240 mg/dL, LDL cholesterol ≥ 160 mg/dL, or TG ≥ 200 mg/dl
Trial locations and contacts
1 site in 1 country.
Spain1 site
Institute of Food Science, Technology and Nutrition, National Research Council (ICTAN-CSIC)
Madrid, Madrid, 28040
About this study
Official title: Health Effects of Chronic Supplementation with a Natural Extract High in Hydroxytyrosol in Individuals At High Risk of Developing Age-related Diseases
The primary objective of this study is to ascertain the effects of chronic consumption of a hydroxytyrosol-rich extract from olive in a population at high risk of developing age-related pathologies such as type 2 diabetes and cardiovascular diseases. The markers measured will be associated with oxidative stress, inflammation, and homeostasis glucose and lipid profiles. Improvements in these parameters could potentially prevent the onset of pathologies associated with aging.
Read the detailed description
Fifty subjects 40-75 years old overweight (BMI between 24-29,9 kg/m2) and prediabetes (fasting blood sugar between 100-126 mg/dl and/or glycated hemoglobin between 5,7-6,4%) will be recruited. Detailed inclusion and exclusion criteria are provided below.
Participants will be randomly divided into two groups, one to consume the Hytolive® capsule and the other a placebo. The intervention study has been designed for daily consumption before breakfast of one capsule for 16 weeks. The study includes a two-week washout period during which subjects will not be allowed to consume olives or virgin olive oil.
At the beginning and end of the study, upon arrival at the ICTAN-CSIC Human Nutrition Unit, volunteers will provide a urine sample corresponding to the first morning void, and a nurse will draw a fasting blood sample (20 mL distributed in tubes with various anticoagulants for measurements). Additionally, their blood pressure will be measured, and a complete anthropometric and body composition study will be conducted. Furthermore, volunteers will provide a stool sample from the preceding days (these samples will not be used in this study but will be stored at -80°C for potential future determination of the intestinal microbiota metagenomic profile). Subsequently, dietary controls will be conducted, physical activity and emotional well-being tests will be administered, and fatigue will be evaluated. Additionally, there will be an interim visit aimed at verifying adherence to supplementation. For this purpose, volunteers will provide a urine sample corresponding to the first morning void on an empty stomach, in which levels of hydroxytyrosol and its derivatives will be determined. Likewise, dietary and physical activity controls will be conducted to confirm that volunteers are not altering their habits.
- Conditions
- Overweight, PreDiabetes
- Being tested
- Group 1, hydroxytyrosol-rich extract capsule, Group 2, capsule of placebo
- Keywords
- Hydroxytyrosol, Prediabetes, Age-related diseases, Antioxidant
- Medical subject headings
- Overweight, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1, hydroxytyrosol-rich extract capsuleDietary supplement
Following a two-week washout period, the subjects will receive a bottle containing capsules (Group 1). Blood, urine, and fecal samples will be collected from each participant during their stay at the Human Nutrition Unit at the beginning and end of the study. Subjects will be instructed to refrain from consuming products rich in hydroxytyrosol (such as virgin olive oil and olives) and to maintain their usual dietary habits throughout the study. Additionally, olive oil (1L/week) will be provided to each volunteer that will consume during intervention study as the sole source of dietary fat, used for cooking, salad dressing, toasts, etc. in order to control the extra consumption of hydroxytyrosol apart from that provided by the capsule.
Group 2, capsule of placeboDietary supplement
Following a two-week washout period, the subjects will receive a bottle containing capsules (Placebo) (Group 2). Blood, urine, and fecal samples will be collected from each participant during their stay at the Human Nutrition Unit at the beginning and end of the study. Subjects will be instructed to refrain from consuming products rich in hydroxytyrosol (such as virgin olive oil and olives) and to maintain their usual dietary habits throughout the study. Additionally, olive oil (1L/week) will be provided to each volunteer that will consume during intervention study as the sole source of dietary fat, used for cooking, salad dressing, toasts, etc. in order to control the extra consumption of hydroxytyrosol.
| Study group | Role | What they receive |
|---|---|---|
| Capsule of an olive extract with a high content of hydroxytytorosol. Group 1 | Experimental | Intake of one capsule/day containing 15 mg of hydroxytyrosol before breakfast for 16 weeks. Receives: Dietary Supplement: Group 1, hydroxytyrosol-rich extract capsule |
| Capsule of placebo. Group 2 | Active comparator | Intake of one capsule placebo/day without hydroxytyrosol before breakfast for 16 weeks. Receives: Dietary Supplement: Group 2, capsule of placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-ox as marker of oxidative status
Differences between subjects supplemented with hydroxytyrosol and non-supplemented subjects
Measured: Up to six months
Secondary outcomes (22)
Mental well-being determined by Warwick-Edinburgh Mental Well-being Scale
Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects
Measured: Up to two months
Sleep quality determined by Pittsburgh Sleep Quality Index
Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects
Measured: Up to two months
Fatigue test determined by Borg Rating Of Perceived Exertion
Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects
Measured: Up to two months
Fasting glucose
Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects
Measured: Up to six months
Fasting insulin
Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects
Measured: Up to six months
Glycated hemoglobin (HbA1c)
Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects
Measured: Up to six months
Glucagon-like peptide-1 (GLP-1)
Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects
Measured: Up to six months
Total cholesterol
Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects
Measured: Up to six months
High density lipoproteins (HDL)
Differences between subjects supplemented with hydrpxytyrosol and no-supplemented subjects
Measured: Up to six months
Low density lipoproteins (LDL)
Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects
Measured: Up to six months
Triglycerides
Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects
Measured: Up to six months
Apoliporpotein A1
Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects
Measured: Up to six months
Apoliporpotein B
Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects
Measured: Up to six months
Total antioxidant status (TAS)
Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects
Measured: Up to six months
Total oxidative status (TOS)
Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects
Measured: Up to six months
Oxides of nitrogen (NOx)
Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects
Measured: Up to six months
Thiobarbituric acid reactive substances (TBARS)
Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects
Measured: Up to six months
C reactive protein
Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects
Measured: Up to six months
Interleukine 6 (IL-6)
Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects
Measured: Up to six months
Tumor necrosis factor alpha (TNF-α)
Differences between subjects supplemented with hydroxytyrosoland no-supplemented subjects
Measured: Up to six months
Alanine aminotransfesare (transaminases ALT)
Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects
Measured: Up to six months
Aspartate aminotransferase (transaminase AST)
Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects
Measured: Up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start1 Dec 2023
- Primary completion30 Sep 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies 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
- Parallel groups
- Model description
- Group 1, hydroxytyrosol-rich extract pill; Group 2, placebo pill
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Council, Spain
- Sponsor type
- Other government
- Collaborators
- Genosa I+D
- Responsible party
- Principal investigator, María Raquel Mateos Briz, National Research Council, Spain
- Investigators
- Raquel Mateos, PhD, Principal investigator, Institute of Food Science, Technology and Nutrition (ICTAN-CSIC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06295913
- Sponsor's protocol ID
- HT15
- Acronym
- HT15
- Status last verified
- Feb 2024
- First submitted
- 20 Feb 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moratilla-Rivera I, Perez-Jimenez J, Ramos S, Portillo MP, Martin MA, Mateos R. Hydroxytyrosol supplementation improves antioxidant and anti-inflammatory status in individuals with overweight and prediabetes: A randomized, double-blind, placebo-controlled parallel trial. Clin Nutr. 2025 Sep;52:17-26. doi: 10.1016/j.clnu.2025.07.006. Epub 2025 Jul 12.
PubMed 40690822
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Effects of Chronic Supplementation with a Natural Extract High in Hydroxytyrosol in Individuals At High Risk of Developing Age-related Diseases
- ClinicalTrials.gov ID
- NCT06295913
- Acronym / sponsor ID
- HT15 / HT15
- Conditions
- Overweight, PreDiabetes
- Keywords
- Hydroxytyrosol, Prediabetes, Age-related diseases, Antioxidant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- National Research Council, SpainOther government
- Collaborators
- Genosa I+D
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 6 Mar 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.
The primary objective of this study is to ascertain the effects of chronic consumption of a hydroxytyrosol-rich extract from olive in a population at high risk of developing age-related pathologies such as type 2 diabetes and cardiovascular diseases. The markers measured will be associated with oxidative stress, inflammation, and homeostasis glucose and lipid profiles. Improvements in these parameters could potentially prevent the onset of pathologies associated with aging.
Detailed description
Fifty subjects 40-75 years old overweight (BMI between 24-29,9 kg/m2) and prediabetes (fasting blood sugar between 100-126 mg/dl and/or glycated hemoglobin between 5,7-6,4%) will be recruited. Detailed inclusion and exclusion criteria are provided below.
Participants will be randomly divided into two groups, one to consume the Hytolive® capsule and the other a placebo. The intervention study has been designed for daily consumption before breakfast of one capsule for 16 weeks. The study includes a two-week washout period during which subjects will not be allowed to consume olives or virgin olive oil.
At the beginning and end of the study, upon arrival at the ICTAN-CSIC Human Nutrition Unit, volunteers will provide a urine sample corresponding to the first morning void, and a nurse will draw a fasting blood sample (20 mL distributed in tubes with various anticoagulants for measurements). Additionally, their blood pressure will be measured, and a complete anthropometric and body composition study will be conducted. Furthermore, volunteers will provide a stool sample from the preceding days (these samples will not be used in this study but will be stored at -80°C for potential future determination of the intestinal microbiota metagenomic profile). Subsequently, dietary controls will be conducted, physical activity and emotional well-being tests will be administered, and fatigue will be evaluated. Additionally, there will be an interim visit aimed at verifying adherence to supplementation. For this purpose, volunteers will provide a urine sample corresponding to the first morning void on an empty stomach, in which levels of hydroxytyrosol and its derivatives will be determined. Likewise, dietary and physical activity controls will be conducted to confirm that volunteers are not altering their habits.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Group 1, hydroxytyrosol-rich extract pill; Group 2, placebo pill
| Arm | Type | Receives |
|---|---|---|
| Capsule of an olive extract with a high content of hydroxytytorosol. Group 1 | Experimental | Dietary Supplement: Group 1, hydroxytyrosol-rich extract capsuleIntake of one capsule/day containing 15 mg of hydroxytyrosol before breakfast for 16 weeks. |
| Capsule of placebo. Group 2 | Active comparator | Dietary Supplement: Group 2, capsule of placeboIntake of one capsule placebo/day without hydroxytyrosol before breakfast for 16 weeks. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Prediabetes (defined as fasting glucose levels according to the American Diabetes Association guideline, with fasting blood glucose ≥100 and <126 mg/dL, or hemoglobin A1c levels ranging from 5.7% to 6.4%)
- Overweight (body mass index BMI 24-29.9 kg/m2)
Key exclusion criteria (8 listed)
- Any prior diagnosis of diabetes, hypertension, hyperlipidemia, other cardiovascular diseases, thyroid gland disorders, asthma, arthritis, or inflammatory conditions, cirrhosis, or other liver diseases
- Weight loss > 2.5 kg in the last 6 months
- Being on pharmacological treatment of any kind
- Taking dietary supplements containing antioxidants other than vitamins
- Being a smoker or habitual alcohol consumer; being HIV positive
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 |
|---|---|---|
| Group 1, hydroxytyrosol-rich extract capsuleFollowing a two-week washout period, the subjects will receive a bottle containing capsules (Group 1). Blood, urine, and fecal samples will be collected from each participant during their stay at the Human Nutrition Unit at the beginning and end of the study. Subjects will be instructed to refrain from consuming products rich in hydroxytyrosol (such as virgin olive oil and olives) and to maintain their usual dietary habits throughout the study. Additionally, olive oil (1L/week) will be provided to each volunteer that will consume during intervention study as the sole source of dietary fat, used for cooking, salad dressing, toasts, etc. in order to control the extra consumption of hydroxytyrosol apart from that provided by the capsule. | Dietary supplement | Capsule of an olive extract with a high content of hydroxytytorosol. Group 1 |
| Group 2, capsule of placeboFollowing a two-week washout period, the subjects will receive a bottle containing capsules (Placebo) (Group 2). Blood, urine, and fecal samples will be collected from each participant during their stay at the Human Nutrition Unit at the beginning and end of the study. Subjects will be instructed to refrain from consuming products rich in hydroxytyrosol (such as virgin olive oil and olives) and to maintain their usual dietary habits throughout the study. Additionally, olive oil (1L/week) will be provided to each volunteer that will consume during intervention study as the sole source of dietary fat, used for cooking, salad dressing, toasts, etc. in order to control the extra consumption of hydroxytyrosol. | Dietary supplement | Capsule of placebo. Group 2 |
Primary outcome
LDL-ox as marker of oxidative status
Time frame: Up to six months
Differences between subjects supplemented with hydroxytyrosol and non-supplemented subjects
22 secondary outcomes
Mental well-being determined by Warwick-Edinburgh Mental Well-being Scale
Time frame: Up to two months
Sleep quality determined by Pittsburgh Sleep Quality Index
Time frame: Up to two months
Fatigue test determined by Borg Rating Of Perceived Exertion
Time frame: Up to two months
Fasting glucose
Time frame: Up to six months
Fasting insulin
Time frame: Up to six months
Glycated hemoglobin (HbA1c)
Time frame: Up to six months
Glucagon-like peptide-1 (GLP-1)
Time frame: Up to six months
Total cholesterol
Time frame: Up to six months
High density lipoproteins (HDL)
Time frame: Up to six months
Low density lipoproteins (LDL)
Time frame: Up to six months
Triglycerides
Time frame: Up to six months
Apoliporpotein A1
Time frame: Up to six months
Apoliporpotein B
Time frame: Up to six months
Total antioxidant status (TAS)
Time frame: Up to six months
Total oxidative status (TOS)
Time frame: Up to six months
Oxides of nitrogen (NOx)
Time frame: Up to six months
Thiobarbituric acid reactive substances (TBARS)
Time frame: Up to six months
C reactive protein
Time frame: Up to six months
Interleukine 6 (IL-6)
Time frame: Up to six months
Tumor necrosis factor alpha (TNF-α)
Time frame: Up to six months
Alanine aminotransfesare (transaminases ALT)
Time frame: Up to six months
Aspartate aminotransferase (transaminase AST)
Time frame: Up to six months
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 12 Feb 2025.
- Derived from this study: PubMed 40690822Moratilla-Rivera I, Perez-Jimenez J, Ramos S, Portillo MP, Martin MA, Mateos R. Hydroxytyrosol supplementation improves antioxidant and anti-inflammatory status in individuals with overweight and prediabetes: A randomized, double-blind, placebo-controlled parallel trial. Clin Nutr. 2025 Sep;52:17-26. doi: 10.1016/j.clnu.2025.07.006. Epub 2025 Jul 12.
- 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.
Raquel Mateos, PhD principal investigator
Institute of Food Science, Technology and Nutrition (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 Group 1, hydroxytyrosol-rich extract capsule in people with Overweight and PreDiabetes, run by National Research Council, Spain 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 2 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: finished, as of the sponsor's last update on 12 Feb 2025. 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?
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?
LDL-ox as marker of oxidative status (time frame: Up to six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06295913, which also lists 1 linked publication.
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 12 Feb 2025.