Olives for a Healthy Lifestyle

Overseen By Tassos Kyriakides, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Pregnancy, Olive allergy, Blood draw reactions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 5 weeks

226 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to assess whether introducing table olives into the diet results in health-related benefits for young adults. Several studies have shown that addition of olives as part of somebody's diet has a positive impact on cardiovascular, metabolic, and inflammatory factors. However, there have not been many studies among young, healthy adults. This study will compare levels of specific biomarkers, collected through blood draw, at the beginning of the study and after 5 weeks, to evaluate the effects of investigational daily olive consumption.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is it safe to consume olives or olive extracts?

Research shows that consuming olives and olive extracts, which contain compounds like oleuropein and hydroxytyrosol, is generally safe for humans. Studies have found no safety concerns with olive extracts at certain doses, and traditional consumption of olives is considered safe as part of a regular diet. ^{1 2 3 4 5}

How do olives as a treatment differ from other options for this condition?

Olives are unique as a treatment due to their high content of phenolic antioxidants like hydroxytyrosol and oleuropein, which have various health benefits such as antioxidant and anti-inflammatory properties. Unlike many conventional treatments, olives are a natural food source and part of the Mediterranean diet, offering a novel approach by incorporating dietary changes rather than relying solely on medication. ^{1 6 7 8 9}

What data supports the effectiveness of the treatment Olives for a healthy lifestyle?

Research shows that olive oil, a key component of olives, is linked to a lower risk of heart disease, type 2 diabetes, and certain cancers. The Mediterranean diet, which includes olives, is known for its health benefits, including improved heart health and reduced risk of chronic diseases. ^{10 11 12 13 14}

Who Is on the Research Team?

Tassos Kyriakides, PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for Yale College Freshmen, Sophomores, or Juniors aged 18+, willing to eat 6 olives daily and participate in all study procedures. Excluded are those who already consume lots of olives or olive oil, have allergies to olives, issues with blood draws, are pregnant, or seniors.

Inclusion Criteria

Stated willingness to comply with all study procedures and availability for the duration of the study

I am willing and able to sign the informed consent.

I am a Freshman, Sophomore, or Junior at Yale College.

Exclusion Criteria

Inability to consume fruit with pits

Known allergic reactions to olives and/or their derivatives

Known reactions to blood draw

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Online screening survey

Enrollment

Eligible participants are consented and enrolled in the study

1 week

In-person consent at dining hall

Treatment

Participants consume 6 organic olives daily for 5 weeks

5 weeks

Daily monitoring via dining hall card swipe

Follow-up

Participants are monitored for changes in metabolic and inflammatory biomarkers

1 week

Blood draw at baseline and week 5

What Are the Treatments Tested in This Trial?

Interventions

• Olives

Trial Overview The study tests if eating table olives daily can benefit the health of young adults. It measures changes in cardiovascular and metabolic biomarkers from blood samples before and after a period of five weeks of olive consumption.

How Is the Trial Designed?

Group I: Investigational Experimental Treatment 1 Intervention

Yale Dining menu + 6 olives daily

Group II: Standard Active Control 1 Intervention

Yale Dining menu only

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Published Research Related to This Trial

The Mediterranean Diet (MedDiet) has been linked to numerous health benefits, particularly in reducing the risk of cardiovascular diseases, metabolic disorders, and cancer, as evidenced by an increase in clinical trials over the last decade.

The diet's positive effects are largely attributed to its anti-inflammatory and antioxidant properties, with strict adherence and specific components like olive oil playing crucial roles in managing obesity and waist circumference.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mediterranean Diet: An Update of the Clinical Trials. Finicelli, M., Di Salle, A., Galderisi, U., et al.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Effect of olive oil consumption on cardiovascular disease, cancer, type 2 diabetes, and all-cause mortality: A systematic review and meta-analysis. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

The Mediterranean Diet: An Update of the Clinical Trials. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Olive oil and cardiovascular health. [2015]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Olive oil and health: summary of the II international conference on olive oil and health consensus report, Jaén and Córdoba (Spain) 2008. [2022]

5. Spain pubmed.ncbi.nlm.nih.gov

[Evaluation of a nutritional intervention among elderly people: the Edumay project]. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Identification of Throuba Thassos, a traditional Greek table olive variety, as a nutritional rich source of oleuropein. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Olive oil consumption, BMI, and risk of obesity in Spanish adults. [2015]

8. Ireland pubmed.ncbi.nlm.nih.gov

Olive juice dry extract containing hydroxytyrosol, as a nontoxic and safe substance: Results from pre-clinical studies and review of toxicological studies. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Safety assessment of aqueous olive pulp extract as an antioxidant or antimicrobial agent in foods. [2006]

10. Spain pubmed.ncbi.nlm.nih.gov

[Assessment of cytotoxicity and biosafety of polyphenolic extracts from olive pits]. [2014]

11. United States pubmed.ncbi.nlm.nih.gov

Biophenols in table olives. [2019]

12. Venezuela pubmed.ncbi.nlm.nih.gov

[The quality of fat: olive oil]. [2016]

13. United States pubmed.ncbi.nlm.nih.gov

Olive tree (Olea europaea) leaves: potential beneficial effects on human health. [2022]

14. England pubmed.ncbi.nlm.nih.gov

Evaluation of bioactive compounds in black table olives fermented with selected microbial starters. [2020]