Health-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For Health

NCT05218980 | Not Yet Recruiting DMC

• 2 other identifiers: 2000031519000
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Diet; Cholesterol; Healthy Lifestyle; Healthy Nutrition

Keywords

olives

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Mean LDL at Week 5

  Blood draw to assess LDL at baseline and week five. Change will be calculated by comparing means of the differences (5 weeks-Baseline) between the two study groups, a decrease in the mean from baseline is positive.

  at baseline and week 5

• Compliance/adherence to daily intervention

  Assessment and verification of receipt of the olives will be tied to the dining hall card swipe that is part of the student's access to the dining facility, for study participants in the olives group. Swipe=adherent.

  up to week 5

Secondary Outcomes (4)

• Change From Baseline in Mean HDL at Week 5

  at baseline and week 5

• Change From Baseline in Mean LDL/HDL at Week 5

  at baseline and week 5

• Change From Baseline in Mean HbA1c at Week 5

  at baseline and week 5

• Change From Baseline in Mean CRP at Week 5

  at baseline and week 5

Study Arms (2)

Investigational

EXPERIMENTAL

Yale Dining menu + 6 olives daily

Dietary Supplement: Olives

Standard

NO INTERVENTION

Yale Dining menu only

Interventions

Olives DIETARY_SUPPLEMENT

Organic olives (provided by Sakellaropoulos Organic Farms; Sparta, Greece)

Investigational

Eligibility Criteria

• Age: 18 Years - 23 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Yale College Freshman, Sophomore, or Junior
• Ability and desire to sign informed consent
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, age 18 on the day of consent
• Ability and desire to consume 6 olives daily

You may not qualify if:

• Yale College Senior
• Unable to provide informed consent form
• Self-reported pregnancy
• Unwillingness to comply with all study procedures and/or be available for the duration of the study
• Inability and desire to consistently consume 6 olives per day
• Inability to consume fruit with pits
• Current and consistent use of \> 6 olives per day
• Current and consistent use of ≥ 1 tablespoon of extra virgin olive oil (EVOO) per day
• Known allergic reactions to olives and/or their derivatives
• Known reactions to blood draw

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale University

New Haven, Connecticut, 06520, United States

Location

Study Officials

• Tassos Kyriakides, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tassos Kyriakides, PhD

CONTACT

(203) 606-1401; tassos.kyriakides@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 1, 2022
• Study Start: January 1, 2026
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 12 months and ending 36 months following primary publication.
• Access Criteria: Proposals should be directed to tassos.kyriakides@yale.edu. To gain access, data requestors will need to sign a data use access/use agreement and have approval from an institutional review board/ethics board for the proposed use of such data.

Locations

US (1)