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| Name | Class |
|---|---|
| Genosa I+D | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Capsule of placebo. Group 2 | Active Comparator | Intake of one capsule placebo/day without hydroxytyrosol before breakfast for 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group 1, hydroxytyrosol-rich extract capsule | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| LDL-ox as marker of oxidative status | Differences between subjects supplemented with hydroxytyrosol and non-supplemented subjects | Up to six months |
| Measure | Description | Time Frame |
|---|---|---|
| Mental well-being determined by Warwick-Edinburgh Mental Well-being Scale | Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects | Up to two months |
| Sleep quality determined by Pittsburgh Sleep Quality Index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raquel Mateos, PhD | Institute of Food Science, Technology and Nutrition (ICTAN-CSIC) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Food Science, Technology and Nutrition, National Research Council (ICTAN-CSIC) | Madrid | Madrid | 28040 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40690822 | Derived | 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. |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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Group 1, hydroxytyrosol-rich extract pill; Group 2, placebo pill
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Participants will be randomly allocated to treatment A and B. Both pills will have the same aspect and will be packed similarly
|
| Group 2, capsule of placebo | Dietary 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. |
|
Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects
| Up to two months |
| Fatigue test determined by Borg Rating Of Perceived Exertion | Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects | Up to two months |
| Fasting glucose | Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects | Up to six months |
| Fasting insulin | Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects | Up to six months |
| Glycated hemoglobin (HbA1c) | Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects | Up to six months |
| Glucagon-like peptide-1 (GLP-1) | Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects | Up to six months |
| Total cholesterol | Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects | Up to six months |
| High density lipoproteins (HDL) | Differences between subjects supplemented with hydrpxytyrosol and no-supplemented subjects | Up to six months |
| Low density lipoproteins (LDL) | Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects | Up to six months |
| Triglycerides | Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects | Up to six months |
| Apoliporpotein A1 | Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects | Up to six months |
| Apoliporpotein B | Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects | Up to six months |
| Total antioxidant status (TAS) | Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects | Up to six months |
| Total oxidative status (TOS) | Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects | Up to six months |
| Oxides of nitrogen (NOx) | Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects | Up to six months |
| Thiobarbituric acid reactive substances (TBARS) | Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects | Up to six months |
| C reactive protein | Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects | Up to six months |
| Interleukine 6 (IL-6) | Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects | Up to six months |
| Tumor necrosis factor alpha (TNF-α) | Differences between subjects supplemented with hydroxytyrosoland no-supplemented subjects | Up to six months |
| Alanine aminotransfesare (transaminases ALT) | Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects | Up to six months |
| Aspartate aminotransferase (transaminase AST) | Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects | Up to six months |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |