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Completed

NCT Number: NCT06295913

Hydroxytyrosol Dietary Supplement and Prevention of 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.

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Key information

Conditions

Overweight Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms PreDiabetes Prediabetic State Signs and Symptoms

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Food Science, Technology and Nutrition, National Research Council (ICTAN-CSIC)

Madrid, 28040, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. LDL-ox as marker of oxidative status

    Time frame: Up to six months

    Differences between subjects supplemented with hydroxytyrosol and non-supplemented subjects

Secondary outcomes

  1. Mental well-being determined by Warwick-Edinburgh Mental Well-being Scale

    Time frame: Up to two months

    Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects

  2. Sleep quality determined by Pittsburgh Sleep Quality Index

    Time frame: Up to two months

    Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects

  3. Fatigue test determined by Borg Rating Of Perceived Exertion

    Time frame: Up to two months

    Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects

  4. Fasting glucose

    Time frame: Up to six months

    Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects

  5. Fasting insulin

    Time frame: Up to six months

    Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects

  6. Glycated hemoglobin (HbA1c)

    Time frame: Up to six months

    Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects

  7. Glucagon-like peptide-1 (GLP-1)

    Time frame: Up to six months

    Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects

  8. Total cholesterol

    Time frame: Up to six months

    Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects

  9. High density lipoproteins (HDL)

    Time frame: Up to six months

    Differences between subjects supplemented with hydrpxytyrosol and no-supplemented subjects

  10. Low density lipoproteins (LDL)

    Time frame: Up to six months

    Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects

  11. Triglycerides

    Time frame: Up to six months

    Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects

  12. Apoliporpotein A1

    Time frame: Up to six months

    Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects

  13. Apoliporpotein B

    Time frame: Up to six months

    Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects

  14. Total antioxidant status (TAS)

    Time frame: Up to six months

    Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects

  15. Total oxidative status (TOS)

    Time frame: Up to six months

    Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects

  16. Oxides of nitrogen (NOx)

    Time frame: Up to six months

    Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects

  17. Thiobarbituric acid reactive substances (TBARS)

    Time frame: Up to six months

    Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects

  18. C reactive protein

    Time frame: Up to six months

    Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects

  19. Interleukine 6 (IL-6)

    Time frame: Up to six months

    Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects

  20. Tumor necrosis factor alpha (TNF-α)

    Time frame: Up to six months

    Differences between subjects supplemented with hydroxytyrosoland no-supplemented subjects

  21. Alanine aminotransfesare (transaminases ALT)

    Time frame: Up to six months

    Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects

  22. Aspartate aminotransferase (transaminase AST)

    Time frame: Up to six months

    Differences between subjects supplemented with hydroxytyrosol and no-supplemented subjects

Sponsors and collaborators

Lead sponsor

National Research Council, Spain

Other Gov

Collaborators

  • Genosa I+D

Registry information

Official study title

Health Effects of Chronic Supplementation with a Natural Extract High in Hydroxytyrosol in Individuals At High Risk of Developing Age-related Diseases

Acronym: HT15

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 6, 2024
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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