Nuts and Oil Pilot Study

NCT04361617 | Completed Results

• 2 other identifiers: IRB00065273UL1TR001420
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

metabolic syndrome; extra virgin olive oil; tree nuts; DNA methylation

Outcome Measures

Primary Outcomes (5)

• Proportion of Participants With MetS With Epigenetic Age Acceleration

  To characterize the relationship between MetS and epigenetic aging, we will examine epigenetic age acceleration prevalence among the 50 participants with metabolic syndrome.

  In-person 1 day assessment visit

• Proportion of Days for Which EVOO Was Taken

  Adherence for each participant will be measured as the proportion of days in 4 weeks for which EVOO was taken

  4 weeks

• Proportion of Days for Which Nuts Were Taken

  Adherence for each participant will be measured as the proportion of days in 4 weeks for which nuts were taken

  4 weeks

• Proportion of Days for Which Nuts and EVOO Were Taken

  Adherence for each participant will be measured as the proportion of days in 4 weeks for which both nuts and of EVOO were taken

  4 weeks

• Percentage of Participants Would be Able to Continue Eating the Tree Nuts and EVOO for a Study Like This Lasting 3-4 Years

  Qualitative interview with open-ended questions designed to ascertain participant understanding of epigenetic age, and assess the challenges and motivators participants encountered during the intervention. Will be assessed using qualitative analysis methods.

  After 4-week intervention

Secondary Outcomes (1)

• Changes in Epigenetic Age Acceleration

  In-person 1 day assessment visit vs. final 1 day visit after 4-week intervention

Study Arms (2)

Epigenetic age knowledge arm

ACTIVE COMPARATOR

Half of the intervention participants will be randomly selected to be informed of epigenetic age before the intervention.

Behavioral: Daily consumption of tree nuts and extra virgin olive oil

No epigenetic age knowledge arm

ACTIVE COMPARATOR

The other half of intervention participants will not be informed of epigenetic age before the intervention.

Behavioral: Daily consumption of tree nuts and extra virgin olive oil

Interventions

Daily consumption of tree nuts and extra virgin olive oil BEHAVIORAL

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.

Epigenetic age knowledge arm; No epigenetic age knowledge arm

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and Women ≥ 35 years of age
• Metabolic syndrome, defined as \> 3 of the following:
• Waist circumference \>102 cm in men and \>88cm in women, triglycerides \>150 mg/dL and/or drug treatment for elevated triglycerides, HDL cholesterol \<40 mg/dL in men and \<50 mg/dL in women and/or drug treatment for reduced HDL cholesterol, systolic blood pressure \>130 mm Hg or diastolic blood pressure \>85 mmHg and/or antihypertensive drug treatment, and fasting glucose \>100 mg/dL or hemoglobin A1c \> 5.6% and/or oral hypoglycemic medications.
• Willing to comply with study visits, as outlined in the protocol
• Able to read and speak English
• No allergies or hypersensitivities to olive oil or nuts
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Plans to move from the study area in the next 12 weeks
• Body Mass Index (BMI) \> 40 kg/m2
• Dementia that is medically documented or suspected, or clinical evidence of cognitive impairment sufficient to impair protocol adherence
• Candidate with any dietary practice, behavior or attitude that would substantially limit ability to adhere to protocol
• Homebound for medical reasons
• Living in the same household with another participant
• Insulin-dependent Diabetes

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Lindsay Reynolds, PhD
• Organization: Wake Forest University Health Sciences

lireynol@wakehealth.edu

336.713.1134

Study Officials

• Lindsay Reynolds, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Knowledge of intervention arm will not be given to research labs with samples
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: April 24, 2020
• Study Start: July 19, 2021
• Primary Completion: April 20, 2022
• Study Completion: April 20, 2022
• Last Updated: September 18, 2023
• Results First Posted: September 18, 2023

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)