A Feasibility Study of Tree Nut and Extra Virgin Olive Oil Supplementation to Improve Cardiometabolic Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Proportion of Days for Which Nuts and EVOO Were Taken
研究概览
简要总结
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.
详细描述
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:
- To determine the proportion of participants with MetS with epigenetic age acceleration
- 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
- 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
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
Knowledge of intervention arm will not be given to research labs with samples
入排标准
- 年龄范围
- 35 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Proportion of Days for Which Nuts and EVOO Were Taken
时间窗: 4 weeks
Adherence for each participant will be measured as the proportion of days in 4 weeks for which both nuts and of EVOO were taken
Proportion of Participants With MetS With Epigenetic Age Acceleration
时间窗: In-person 1 day assessment visit
To characterize the relationship between MetS and epigenetic aging, we will examine epigenetic age acceleration prevalence among the 50 participants with metabolic syndrome.
Proportion of Days for Which EVOO Was Taken
时间窗: 4 weeks
Adherence for each participant will be measured as the proportion of days in 4 weeks for which EVOO was taken
Proportion of Days for Which Nuts Were Taken
时间窗: 4 weeks
Adherence for each participant will be measured as the proportion of days in 4 weeks for which nuts were taken
Percentage of Participants Would be Able to Continue Eating the Tree Nuts and EVOO for a Study Like This Lasting 3-4 Years
时间窗: After 4-week intervention
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.
次要结局
- Changes in Epigenetic Age Acceleration(In-person 1 day assessment visit vs. final 1 day visit after 4-week intervention)
