Hydroxytyrosol Dietary Supplement and Prevention of Age-Related Diseases

NCT06295913 | Completed

• 1 other identifier: HT15
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Overweight; PreDiabetes

Keywords

Hydroxytyrosol; Prediabetes; Age-related diseases; Antioxidant

Outcome Measures

Primary Outcomes (1)

• LDL-ox as marker of oxidative status

  Differences between subjects supplemented with hydroxytyrosol and non-supplemented subjects

  Up to six months

Secondary Outcomes (22)

• Mental well-being determined by Warwick-Edinburgh Mental Well-being Scale

  Up to two months

• Sleep quality determined by Pittsburgh Sleep Quality Index

  Up to two months

• Fatigue test determined by Borg Rating Of Perceived Exertion

  Up to two months

• Fasting glucose

  Up to six months

• Fasting insulin

  Up to six months

Study Arms (2)

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.

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.

Dietary Supplement: Group 2, capsule of placebo

Interventions

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.

Capsule of an olive extract with a high content of hydroxytytorosol. Group 1

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.

Capsule of placebo. Group 2

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Research Council, Spain: lead
• Genosa I+D: collaborator

Study Sites (1)

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

Madrid, Madrid, 28040, Spain

Location

Related Publications (1)

• 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.

  PMID: 40690822 DERIVED

MeSH Terms

Conditions

Overweight; Prediabetic State

Condition Hierarchy (Ancestors)

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

Study Officials

• Raquel Mateos, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants will be randomly allocated to treatment A and B. Both pills will have the same aspect and will be packed similarly
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Model Details: Group 1, hydroxytyrosol-rich extract pill; Group 2, placebo pill

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: March 6, 2024
• Study Start: December 1, 2023
• Primary Completion: September 30, 2024
• Study Completion: December 20, 2024
• Last Updated: February 12, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)