Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04361617 |
| Other study ID # |
IRB00065273 |
| Secondary ID |
UL1TR001420 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 19, 2021 |
| Est. completion date |
April 20, 2022 |
Study information
| Verified date |
June 2021 |
| Source |
Wake Forest University Health Sciences |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Metabolic syndrome (MetS) is a collection of at least three out of five cardiometabolic risk
factors including abdominal obesity, hypertension, elevated blood glucose,
hypertriglyceridemia, and low high-density lipoprotein cholesterol. MetS is a major risk
factor for cardiovascular disease and is considered a state of prediabetes. Improving
metabolic parameters through dietary, behavioral, and pharmacological interventions can
improve or reverse MetS. For example, increased consumption of extra virgin olive oil (EVOO)
and mixed nuts was shown to reduce cardiovascular event rates and reverse MetS in a 5-year
study in Spain (PREDIMED study). However, lower levels of adherence to the PREDIMED
intervention was found in participants with a higher number of cardiovascular risk factors,
larger waist circumference, and lower physical activity levels at baseline. New strategies to
convey one's risk of morbidity and mortality at the onset of a dietary intervention may
improve intervention adherence, particularly among individuals meeting the criteria for MetS.
A greater DNA methylation-based predicted age relative to chronological age, often referred
to as "epigenetic age acceleration", has been associated with many lifestyle factors,
including physical activity and diet, as well as components of MetS, including obesity, blood
pressure, HDL cholesterol and blood glucose levels.
The investigators hypothesize that the majority of people with MetS have advanced epigenetic
aging, and among those that have advanced epigenetic age, learning one's epigenetic age, and
epigenetic age-based predicted risk of morbidity and mortality at the onset of a dietary
intervention will improve participant adherence to the dietary intervention. Further, the
investigators hypothesize that EVOO and tree nut supplementation in participants with MetS
and advanced epigenetic age could help reverse MetS and potentially slow epigenetic aging.
Therefore, the investigators plan to conduct a feasibility pilot study to:
1. To determine the proportion of participants with MetS with epigenetic age acceleration
2. To assess adherence to daily EVOO and tree nut consumption over a 4-week intervention in
participants informed of epigenetic age acceleration at baseline compared to the control
group
3. Qualitatively explore how participants perceive epigenetic age, and how participants'
experiences would impact the feasibility of a larger clinical intervention in terms of
challenges and motivators
4. Compare epigenetic age acceleration before and after the 4-week intervention
For this study the investigators will recruit ~50 individuals with MetS aged 35 years or
older. An in-person assessment visit will be scheduled for a morning time and participants
will be asked to be fasting and will be instructed to bring their medications to the visit.
Candidates will review the informed consent document at an in-person screening with study
staff prior to beginning their participation. For all participants providing informed
consent, who were fasting and met the MetS criteria at the initial in-person assessment
visit, collected blood samples will be used to calculate epigenetic age acceleration. Other
measures to be collected include body weight, height, waist circumference, blood pressure,
and questionnaires about demographics, health history and health habits. Participants that
meet the inclusion criteria during the in-person screening visit will be contacted to
schedule a baseline intervention visit.
At the intervention visit, all participants will receive a 4-week supply of EVOO and tree
nuts, including unsalted English walnuts, almonds or pistachios (approximately 10-day supply
of each type). Participants will be asked to supplement their normal diets with these
products and will be provided recipes and other information that will allow them to replace
other foods with the nuts and oil. The investigators 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. Dietary adherence diaries will be given to measure incorporation of the
study foods.
Participants will be randomized to learn about epigenetic age acceleration (arm 1) or not to
learn about epigenetic age acceleration (arm 2) in a 1:1 allocation at the baseline visit.
Those in the intervention arm 1 that are to learn about epigenetic age acceleration will
receive some educational materials and a brief description of epigenetic age acceleration.
A telephone visit will be scheduled to take place at the end of week 1 for additional diet
counseling, to assess safety/potential side effects and to collect adherence diaries. A
follow-up phone call for compliance assessment and to answer participant questions will be
conducted at the end of week 2. A final measurement visit will be scheduled for the end of
week 4 for a morning time and participants will be asked to be fasting. At the final
measurement visit, the same measures as listed in the in-person assessment visit will be
performed and study questionnaires, with the exception of demographics and health history,
will be distributed.
After the intervention, participants will be asked to come in for the end of week 4 visit,
For participants in the intervention arm 1 (participants educated about epigenetic age
acceleration), a self- administered exit questionnaire will be given to qualitatively explore
participants' perception of epigenetic age, and challenges and motivators for behavior change
during the intervention, The open-ended questions will be designed to ascertain understanding
of epigenetic age, and assess the challenges and motivators participants encounter during the
intervention.
Participants in both arms will be administered an Intervention Experience Assessment to
explore how participant's experiences would impact the feasibility of a larger clinical
intervention in terms of challenges and motivators.
This feasibility study, incorporating epigenetic age estimates with a dietary intervention in
individuals with MetS, is an initial step in building our understanding of 1) the
relationship between MetS and epigenetic age, 2) how epigenetic age estimates may be
perceived by patients at high risk for CVD, and 3) will provide preliminary longitudinal data
examining the potential to slow epigenetic age acceleration predictions after a 4-week
dietary intervention to provide feasibility for a larger future study.
