Clinical trial NCT06295913: Hydroxytyrosol Dietary Supplement and Prevention of Age-Related Diseases
Official title: Health Effects of Chronic Supplementation with a Natural Extract High in Hydroxytyrosol in Individuals At High Risk of Developing Age-related Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
PreDiabetes
Keywords: Hydroxytyrosol
Prediabetes
Age-related diseases
Antioxidant
Lead sponsor: National Research Council, Spain
Sponsor class: OTHER_GOV
Collaborators: name: Genosa I+D
First posted: 2024-03-06
Enrollment: 49
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1, hydroxytyrosol-rich extract pill; Group 2, placebo pill
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: LDL-ox as marker of oxidative status
timeFrame: Up to six months
Secondary outcomes:
measure: Mental well-being determined by Warwick-Edinburgh Mental Well-being Scale
timeFrame: Up to two months
measure: Sleep quality determined by Pittsburgh Sleep Quality Index
timeFrame: Up to two months
measure: Fatigue test determined by Borg Rating Of Perceived Exertion
timeFrame: Up to two months
measure: Fasting glucose
timeFrame: Up to six months
measure: Fasting insulin
timeFrame: Up to six months
measure: Glycated hemoglobin (HbA1c)
timeFrame: Up to six months
measure: Glucagon-like peptide-1 (GLP-1)
timeFrame: Up to six months
measure: Total cholesterol
timeFrame: Up to six months
measure: High density lipoproteins (HDL)
timeFrame: Up to six months
measure: Low density lipoproteins (LDL)
timeFrame: Up to six months
measure: Triglycerides
timeFrame: Up to six months
measure: Apoliporpotein A1
timeFrame: Up to six months
measure: Apoliporpotein B
timeFrame: Up to six months
measure: Total antioxidant status (TAS)
timeFrame: Up to six months
measure: Total oxidative status (TOS)
timeFrame: Up to six months
measure: Oxides of nitrogen (NOx)
timeFrame: Up to six months
measure: Thiobarbituric acid reactive substances (TBARS)
timeFrame: Up to six months
measure: C reactive protein
timeFrame: Up to six months
measure: Interleukine 6 (IL-6)
timeFrame: Up to six months
measure: Tumor necrosis factor alpha (TNF-α)
timeFrame: Up to six months
measure: Alanine aminotransfesare (transaminases ALT)
timeFrame: Up to six months
measure: Aspartate aminotransferase (transaminase AST)
timeFrame: Up to six months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Institute of Food Science, Technology and Nutrition, National Research Council (ICTAN-CSIC)
state: Comunidad Autónoma de Madrid
Study officials:
affiliation: Institute of Food Science, Technology and Nutrition (ICTAN-CSIC)
name: Raquel Mateos, PhD
role: PRINCIPAL_INVESTIGATOR
References: