Hydroxytyrosol Dietary Supplement and Prevention of Age-Related Diseases

Overweight Clinical Trial

— HYTOLIVE15  

Official title:

Health Effects of Chronic Supplementation With a Natural Extract High in Hydroxytyrosol (Hytolive®) in Individuals at High Risk of Developing Age-related Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06295913
• Other study ID #: HYTOLIVE15
• Status: Recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: National Research Council, Spain
• Contact: Raquel Mateos, PhD
• Phone: +34 91 549 23 00
• Email: raquel.mateos[@]ictan.csic.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to ascertain the effects of chronic consumption of a hydroxytyrosol-rich extract from olive (Hytolive®) 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Intolerance
• Overweight
• PreDiabetes
• Prediabetic State

Intervention

Dietary Supplement:
• Group 1, hydroxytyrosol-rich extract capsule (Hytolive®)
Following a two-week washout period, the subjects will receive a bottle containing capsules (Hytolive®) (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 with (Hytolive®).
• Group 2, capsule of placebo
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.

Locations

Country	Name	City	State
Spain	Institute of Food Science, Technology and Nutrition, National Research Council (ICTAN-CSIC)	Madrid	Comunidad Autónoma De Madrid

Sponsors (2)

Lead Sponsor	Collaborator
National Research Council, Spain	Genosa I+D

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL-ox as marker of oxidative status	Differences between subjects supplemented with Hytolive® and non-supplemented subjects	Up to six months
Secondary	Emotional well-being determined by Warwick-Edinburgh Mental Well-being Scale	Differences between subjects supplemented with Hytolive and no-supplemented subjects	Up to two months
Secondary	Sleep quality determined by Pittsburgh Sleep Quality Index	Differences between subjects supplemented with Hytolive and no-supplemented subjects	Up to two months
Secondary	Fatigue test determined by Borg Rating Of Perceived Exertion	Differences between subjects supplemented with Hytolive and no-supplemented subjects	Up to two months
Secondary	Fasting glucose	Differences between subjects supplemented with Hytolive and no-supplemented subjects	Up to six months
Secondary	Fasting insulin	Differences between subjects supplemented with Hytolive and no-supplemented subjects	Up to six months
Secondary	Glycated hemoglobin (HbA1c)	Differences between subjects supplemented with Hytolive and no-supplemented subjects	Up to six months
Secondary	Glucagon-like peptide-1 (GLP-1)	Differences between subjects supplemented with Hytolive and no-supplemented subjects	Up to six months
Secondary	Total cholesterol	Differences between subjects supplemented with Hytolive and no-supplemented subjects	Up to six months
Secondary	High density lipoproteins (HDL)	Differences between subjects supplemented with Hytolive and no-supplemented subjects	Up to six months
Secondary	Low density lipoproteins (LDL) triglicéridos, apoliporpotein A1 and B)	Differences between subjects supplemented with Hytolive and no-supplemented subjects	Up to six months
Secondary	Triglycerides	Differences between subjects supplemented with Hytolive and no-supplemented subjects	Up to six months
Secondary	Apoliporpotein A1	Differences between subjects supplemented with Hytolive and no-supplemented subjects	Up to six months
Secondary	Apoliporpotein B	Differences between subjects supplemented with Hytolive and no-supplemented subjects	Up to six months
Secondary	Total antioxidant status (TAS)	Differences between subjects supplemented with Hytolive and no-supplemented subjects	Up to six months
Secondary	Total oxidative status (TOS)	Differences between subjects supplemented with Hytolive and no-supplemented subjects	Up to six months
Secondary	Oxides of nitrogen (NOx)	Differences between subjects supplemented with Hytolive and no-supplemented subjects	Up to six months
Secondary	Thiobarbituric acid reactive substances (TBARS)	Differences between subjects supplemented with Hytolive and no-supplemented subjects	Up to six months
Secondary	C reactive protein	Differences between subjects supplemented with Hytolive and no-supplemented subjects	Up to six months
Secondary	Interleukine 6 (IL-6)	Differences between subjects supplemented with Hytolive and no-supplemented subjects	Up to six months
Secondary	Tumor necrosis factor alpha (TNF-a)	Differences between subjects supplemented with Hytolive and no-supplemented subjects	Up to six months
Secondary	Interleukine 10 (IL-10)	Differences between subjects supplemented with Hytolive and no-supplemented subjects	Up to six months
Secondary	Alanine aminotransfesare (transaminases ALT)	Differences between subjects supplemented with Hytolive and no-supplemented subjects	Up to six months
Secondary	Aspartate aminotransferase (transaminase AST)	Differences between subjects supplemented with Hytolive and no-supplemented subjects	Up to six months