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Nuts and Oil Pilot Study

NCT04361617 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2023-09-18

Study results available
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Summary

Metabolic syndrome is considered to be a state of prediabetes and is a major risk factor for cardiovascular disease. Dietary interventions involving extra virgin olive oil (EVOO) supplementation and tree nut consumption can improve cardiometabolic health and reverse metabolic syndrome. The goal of this exploratory study is to establish the feasibility of using a novel measure - epigenetic age - to motivate behavior change and improve cardiometabolic health in individuals with metabolic syndrome.

Conditions

  • Metabolic Syndrome

Interventions

BEHAVIORAL

Daily consumption of tree nuts and extra virgin olive oil

All participants will receive a 4-week supply of extra virgin olive oil and tree nuts, including unsalted English walnuts, almonds or pistachios (approximately 3-day supply of each type). Participants will be asked to include in their normal diets these products and will be provided recipes and other information that will allow them to replace other foods with the nuts and oil. We will ask participants to consume one ounce of tree nuts per day and two tablespoons of EVOO per day by incorporating these foods into their diet.

Sponsors & Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

    collaborator NIH

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Lindsay Reynolds, PhD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-19
Primary Completion
2022-04-20
Completion
2022-04-20

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04361617 on ClinicalTrials.gov